Early ART to Limit Infection and Establishment of Reservoir | NCT02859558 | Trialant
NCT02859558
Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Status
Completed
Last Update Posted
Aug 29, 2025Actual
Enrollment
195Actual
Phase
Phase 2
Conditions
HIV-1 Infection
Interventions
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
Early ART to Limit Infection and Establishment of Reservoir
Official Title
Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses
Acronym
EARLIER
Organization
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsNETWORK
Status Module
Record Verification Date
Aug 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 24, 2017Actual
Primary Completion Date
Dec 2, 2020Actual
Completion Date
Apr 16, 2025Actual
First Submitted Date
Aug 4, 2016
First Submission Date that Met QC Criteria
Aug 4, 2016
First Posted Date
Aug 9, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 2, 2021
Results First Submitted that Met QC Criteria
Dec 2, 2021
Results First Posted Date
Jan 3, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 11, 2025
Last Update Posted Date
Aug 29, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsNETWORK
Collaborators
Name
Class
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The study was done to:
Start antiretroviral therapy (ART) early in those recently or acutely infected with HIV-1
See how starting ART as soon as the infection is found affects the amount of HIV-1 in blood and how well the body fights the HIV-1 infection
Look at the amount of HIV-1 DNA (genetic material for HIV-1) seen in CD4+ T-cells (infection-fighting cells in blood) after 48 weeks of ART
See how early treatment for HIV affects the numbers of HIV-1 infection fighting cells (CD4+ and CD8+ T-cells) in blood
Detailed Description
This was a Phase II, prospective, open-label two-step study to measure the effects of early ART on the establishment of HIV-1 reservoir and HIV-1-specific immunity. Participants were enrolled if they fulfilled the inclusion criteria for acute HIV-1 infection (AHI) diagnosis within 7 days prior to entry and had an enrollment visit with the immediate initiation of ART. Plasma and serum samples for Fiebig staging were collected at the time of ART initiation.
Participants were followed for up to 216 weeks (72 weeks on Step 1 and 144 weeks on Step 2). Evaluations at weeks 2 and 8 on Step 1 were performed via telephone.
The Fiebig stage-classification system was used to characterize the progression from HIV-1 exposure to HIV-1 seroconversion at the time of ART initiation. In this study, the five Fiebig stages of interest were simplified into three study groups as described below (based on HIV-1 antibody diagnostic profile at time of ART initiation).
The primary analysis was based on Step 1. Step 2 was added to the study for long term follow-up. The rationale for the extended follow-up period was to expand the number of available participants for future therapeutic and cure studies without the burden of frequent visits and the cost of study-provided laboratory testing.
Group 1: Fiebig I/II (non-reactive HIV-1 antibody)
Group 2: Fiebig III/IV (reactive HIV-1 antibody and negative or indeterminate results on the Western Blot (WB) or Geenius HIV-1/HIV-2)
Group 3: Fiebig V (reactive HIV-1 antibody and positive WB or Geenius HIV-1/HIV-2 without p31 band)
Although participants in Fiebig VI (positive WB or Geenius HIV-1/HIV-2 with p31 band) were not specifically targeted for enrollment in this study, it was possible that a small number of participants would be determined to be in Fiebig VI (positive Western blot or Geenius HIV-1/HIV-2 with p31 band) based on analysis of the entry samples. Participants who were determined to be in Fiebig VI were followed on the study for no more than 24 weeks on Step 1, allowing ample time for them to pursue alternative sources for ART. Enrolled participants without HIV or in Fiebig VI were replaced.
The study-provided regimen was single tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Other non-study-provided antiretroviral (ARV) regimens were also allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
Conditions Module
Conditions
HIV-1 Infection
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
195Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1: Fiebig I/II
Experimental
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
Arm 2: Fiebig III/IV
Experimental
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
Arm 3: Fiebig V
Experimental
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
Interventions
Name
Type
Description
Arm Group Labels
Other Names
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
Drug
Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)
Proportion of participants with 0 copies of CAHD per 5 million CD4+ blood-derived CD4+ T-cells (assayed by quantitative polymerase chain reaction [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.
At week 48
Secondary Outcomes
Measure
Description
Time Frame
HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
Percent of HIV-1-specific CD4+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero.
Appropriate documentation from medical records of diagnosis of acute HIV-1 infection (AHI) within 7 days prior to enrollment, that includes one of the following:
A detectable HIV-1 RNA within 28 days prior to study entry AND a non-reactive HIV-1 antibody within 7 days prior to entry OR
A detectable HIV-1 RNA or a reactive HIV-1 antibody within 28 days prior to study entry AND a negative/indeterminate WB or negative/indeterminate Geenius HIV-1/HIV-2 Supplemental Assay within 7 days prior to entry OR
A documented non-reactive HIV-1 antibody or negative HIV-1 RNA within 90 days prior to study entry AND a documented reactive HIV-1 antibody or positive WB that is negative for p31 band or a positive Geenius HIV-1/HIV-2 Supplemental Assay that is negative for p31 band within 7 days prior to entry OR
ARCHITECT or GSCOMBO S/CO ≥10 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry OR
ARCHITECT or GSCOMBO S/CO ≥1 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry AND a known prior S/CO <0.5 within 90 days prior to entry OR
ARCHITECT or GSCOMBO S/CO >0.5 but <10 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry AND detectable HIV-1 RNA within 7 days prior to entry
Note A: HIV-1 RNA result must be reported from an FDA-approved or CE-marked assay.
Note B: Since characterization of Fiebig stage using samples at the time of ART initiation was performed with results known within 12 weeks based on standardized, centralized testing, an estimated Fiebig group at enrollment based on inclusion criteria as shown in the table above will provide additional real-time monitoring for accruals into each study group.
Ability and willingness of candidate to provide written informed consent.
Ability and willingness to initiate ART at enrollment.
Ability and willingness to participate in scheduled study visits for up to 72 weeks.
Female candidates of reproductive potential who are not pregnant at the time of enrollment and who will receive the study-provided EVG/COBI/FTC/TAF and must agree not to participate in the conception process (ie, active attempt to become pregnant, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the female candidate must agree to use at least one reliable form of contraceptive while receiving study-provided treatment.
Female candidates are considered to be of reproductive potential if any of the following conditions apply:
Candidate has experienced menarche.
Candidate has not undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.
Candidate has not experienced menopause, defined as lack of menstruation within the preceding 12 months.
Acceptable contraceptive methods include:
Condoms (male or female) with or without a spermicidal agent
Diaphragm or cervical cap with spermicide
Intrauterine device
Hormonal contraceptive
Female candidates who are not of reproductive potential or whose male partner(s) has documented azoospermia are not required to use contraceptives. Any statement of self-reported sterility or that of her partner must be entered in the source documents.
NOTE: Acceptable documentation of lack of reproductive potential is oral or written documentation from the individual.
Female candidates who are prescribed a non-study-provided ARV regimen should discuss the safety of that regimen during conception and pregnancy with the prescribing physician. Such individuals should follow medical guidance regarding any potential need for contraception while using the non-study-provided ARV regimen.
Note: Pregnant and breastfeeding women may enroll in the study provided that they meet the eligibility requirements and have access to non-study-provided ARV regimens.
Exclusion Criteria:
Positive HIV-1 antibody test ≥90 days prior to study entry.
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Any acute, chronic, or recent and clinically significant medical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements or jeopardize the safety or rights of the participant.
Receipt of an investigational study agent within 28 days prior to enrollment
Chronic or recurrent use of medications that modify host immune response, eg, oral or parenteral steroids, cancer chemotherapy.
AHI diagnosis within 60 days after receiving any investigational ARV or HIV-1 vaccine or immune prophylaxis for HIV-1 infection.
Use of ARVs for pre- or post-exposure prophylaxis within 60 days prior to the diagnosis of AHI.
Crowell TA, Ritz J, Coombs RW, Zheng L, Eron JJ, Mellors JW, Dragavon J, van Zyl GU, Lama JR, Ruxrungtham K, Grinsztejn B, Arduino RC, Fox L, Ananworanich J, Daar ES; AIDS Clinical Trials Group A5354/EARLIER (Early ART to Limit Infection and Establishment of Reservoir) Study Team. Novel Criteria for Diagnosing Acute and Early Human Immunodeficiency Virus Infection in a Multinational Study of Early Antiretroviral Therapy Initiation. Clin Infect Dis. 2021 Aug 2;73(3):e643-e651. doi: 10.1093/cid/ciaa1893.
See Also Links
Label
URL
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 2.1, July 2017
Individual participant data that underlie results in the publication, after deidentification.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Time Frame
Beginning 3 months following publication and available throughout period of funding of the Advancing Clinical Therapeutics Globally (ACTG) by NIH.
Access Criteria
With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the ACTG.
For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group.
By what mechanism will data be made available? Researchers may submit a request for access to data using the ACTG "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
There was no randomization in this study. Participants who were determined to be in Fiebig VI were followed on the study for no more than 24 weeks on Step 1. Confirmed Fiebig VI and HIV negative participants were replaced.
Recruitment Details
Participants were enrolled from January 2017 to December 2019 at 30 sites in Brazil, Malawi, Peru, Thailand, United States, and Zimbabwe.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm 1: Fiebig I/II
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
Periods
Title
Milestones
Reasons Not Completed
Step 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 17, 2021
Dec 2, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
South Africa
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Arm 1: Fiebig I/II
Arm 2: Fiebig III/IV
Arm 3: Fiebig V
Single-tablet regimen EVG/COBI/FTC/TAF or Genvoya
Single-tablet regimen BIC/FTC/TAF or Biktarvy
At week 48
HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
Percent of HIV-1-specific CD8+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero.
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation
Proportion of participants with 0 copies of CAHD per million CD4+ blood-derived CD4+ T-cells (assayed by quantitative PCR [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.
At week 0
San Diego
California
92103
United States
Harbor-UCLA Med. Ctr. CRS (603)
Torrance
California
90502
United States
Whitman Walker Health CRS (31791)
Washington D.C.
District of Columbia
20009
United States
The Ponce de Leon Center CRS (5802)
Atlanta
Georgia
30308
United States
Northwestern University CRS (2701)
Chicago
Illinois
60611
United States
Rush Univ. Med. Ctr. ACTG CRS (2702)
Chicago
Illinois
60612
United States
Massachusetts General Hospital ACTG CRS (101)
Boston
Massachusetts
02114
United States
Brigham and Women's Hosp. ACTG CRS (107)
Boston
Massachusetts
02115
United States
Washington University CRS (2101)
St Louis
Missouri
63110
United States
31786 New Jersey Medical School Clinical Research Center CRS
Newark
New Jersey
07103
United States
7804 Weill Cornell Chelsea CRS
New York
New York
10010
United States
Columbia Physicians and Surgeons CRS (30329)
New York
New York
10032
United States
3201 Chapel Hill CRS
Chapel Hill
North Carolina
27516
United States
Greensboro CRS (3203)
Greensboro
North Carolina
27401
United States
Univ. of Cincinnati CRS (2401)
Cincinnati
Ohio
45267
United States
The Ohio State Univ. AIDS CRS (2301)
Columbus
Ohio
43210
United States
6201 Penn Therapeutics CRS
Philadelphia
Pennsylvania
19104
United States
Pittsburgh CRS (1001)
Pittsburgh
Pennsylvania
15213
United States
The Miriam Hosp. ACTG CRS (2951)
Providence
Rhode Island
02906
United States
31443 Trinity Health and Wellness Center CRS
Dallas
Texas
75208
United States
31473 Houston AIDS Research Team (HART) CRS
Houston
Texas
77030
United States
University of Washington AIDS CRS (1401)
Seattle
Washington
98104
United States
Hospital Nossa Senhora da Conceicao CRS (12201)
Porto Alegre
Rio Grande do Sul
9043010
Brazil
Instituto de Pesquisa Clinica Evandro Chagas (12101)
Rio de Janeiro
21045
Brazil
Malawi CRS (12001)
Lilongwe
Malawi
San Miguel CRS (11302)
San Isidro
Lima region
Peru
Barranco CRS
Lima
18
Peru
31802 Thai Red Cross AIDS Research Center Treatment (TRC-ARC Treatment) CRS
Bangkok
Patumwan
10330
Thailand
Milton Park CRS (30313)
Harare
Zimbabwe
Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
FG002
Arm 3: Fiebig V
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
FG003
Fiebig VI
Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
FG004
HIV-negative
Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.
FG00049 subjects
FG00179 subjects
FG00260 subjects
FG0034 subjects
FG0043 subjects
Completed Week 48
FG00041 subjects
FG00168 subjects
FG00250 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG00037 subjects
FG00167 subjects
FG00249 subjects
FG0034 subjects
FG0040 subjects
NOT COMPLETED
FG00012 subjects
FG00112 subjects
FG00211 subjects
FG0030 subjects
FG0043 subjects
Type
Comment
Reasons
Not Eligible
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
Lost to Follow-up
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0030 subjects
FG004
Did Not Return to Clinic
FG0002 subjects
FG0013 subjects
FG0024 subjects
FG0030 subjects
FG004
Moved
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal By Participant
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Had to Interrupt antiretroviral (ARV)
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Incarceration
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Non-Adherence to Study Drug
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Non-Adherence to Study Requirements
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Virologic Failure
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Step 2
Type
Comment
Milestone Data
STARTED
Some participants who completed Step 1 did not enroll to Step 2.
FG00026 subjects
FG00142 subjects
FG00223 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG00022 subjects
FG00137 subjects
FG00219 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0004 subjects
FG0015 subjects
FG0024 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0003 subjects
FG0013 subjects
FG0021 subjects
FG003
All participants with available baseline measurements.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm 1: Fiebig I/II
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
BG001
Arm 2: Fiebig III/IV
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
BG002
Arm 3: Fiebig V
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
BG003
Fiebig VI
Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
BG004
HIV-negative
Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00049
BG00179
BG00260
BG0034
BG0043
BG005195
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Inter-Quartile Range
years
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG00260
ParticipantsBG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
18-29 years
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG002
Sex/Gender, Customized
Count of Participants
Participants
Title
Denominators
Categories
Cisgender
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG002
Sex: Female, Male
Sex at birth.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG002
BMI
Median
Inter-Quartile Range
kg/m^2
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG002
HIV-1 RNA (log10 copies per mL)
RNA levels below the lower limit of quantification (40 copies per mL) were imputed as 39 copies per mL.
Median
Inter-Quartile Range
log10(copies per mL)
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG002
HIV-1 RNA
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG002
CD4 Count
Baseline CD4 measurements were not obtained for three participants.
Median
Inter-Quartile Range
cells per mm^3
Title
Denominators
Categories
ParticipantsBG00048
ParticipantsBG00178
ParticipantsBG002
CD8 Count
Baseline CD8 measurements were not obtained for seven participants.
Median
Inter-Quartile Range
cells per mm^3
Title
Denominators
Categories
ParticipantsBG00047
ParticipantsBG00176
ParticipantsBG002
Cell-associated HIV-1 DNA
Median
Inter-Quartile Range
copies per 5 million CD4+ T-cells
Title
Denominators
Categories
Integrase Assay
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)
Proportion of participants with 0 copies of CAHD per 5 million CD4+ blood-derived CD4+ T-cells (assayed by quantitative polymerase chain reaction [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.
Participants who maintained HIV-1 RNA<50 copies/mL at week 48 with no ART interruption of 7 or more consecutive days, no prior virologic failure (defined as having two consecutive HIV-1 RNA >200 copies/mL at week 24 or later or at any time after achieving HIV-1 RNA <50 copies/mL ), had available CAHD results from week 48 or week 49, and were enrolled during Fiebig Stage I-V.
Posted
Number
95% Confidence Interval
Proportion of participants
At week 48
ID
Title
Description
OG000
Arm 1: Fiebig I/II
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
OG001
Arm 2: Fiebig III/IV
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
OG002
Arm 3: Fiebig V
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
Units
Counts
Participants
OG00040
OG00164
OG00250
Title
Denominators
Categories
Joint Assay (Integrase + Gag)
Title
Measurements
OG0000.00(0.00 to 0.09)
OG0010.00(0.00 to 0.06)
OG0020.00(0.00 to 0.07)
Integrase Assay
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.
Fisher Exact
0.48
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG002
Secondary
HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
Percent of HIV-1-specific CD4+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero.
Participants who maintained HIV-1 RNA<50 copies/mL at week 48 with no ART interruption of 7 or more consecutive days, no prior virologic failure (defined as having two consecutive HIV-1 RNA >200 copies/mL at week 24 or later or at any time after achieving HIV-1 RNA <50 copies/mL ), had available CAHD results from week 48 or week 49, had available immunology marker results where active control result is greater than or equal to the media control, and were enrolled during Fiebig Stage I-V.
Posted
Median
Inter-Quartile Range
Percentage of CD4+ T-cells
At week 48
ID
Title
Description
OG000
Arm 1: Fiebig I/II
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
Secondary
HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
Percent of HIV-1-specific CD8+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero.
Participants who maintained HIV-1 RNA<50 copies/mL at week 48 with no ART interruption of 7 or more consecutive days, no prior virologic failure (defined as having two consecutive HIV-1 RNA >200 copies/mL at week 24 or later or at any time after achieving HIV-1 RNA <50 copies/mL ), had available CAHD results from week 48 or week 49, had available immunology marker results where active control result is greater than or equal to the media control, and were enrolled during Fiebig Stage I-V.
Posted
Median
Inter-Quartile Range
Percentage of CD8+ T-cells
At 48 weeks
ID
Title
Description
OG000
Arm 1: Fiebig I/II
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
Secondary
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation
Proportion of participants with 0 copies of CAHD per million CD4+ blood-derived CD4+ T-cells (assayed by quantitative PCR [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.
All participants who enrolled during Fiebig Stage I-V and had available CAHD at week 0.
Posted
Number
95% Confidence Interval
Proportion of participants
At week 0
ID
Title
Description
OG000
Arm 1: Fiebig I/II
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
OG001
Time Frame
Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
Description
All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Step 1 Arm 1: Fiebig I/II
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
0
49
5
49
48
49
EG001
Step 1 Arm 2: Fiebig III/IV
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
0
79
7
79
67
79
EG002
Step 1 Arm 3: Fiebig V
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
0
60
4
60
50
60
EG003
Step 1 Fiebig VI
Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
0
4
0
4
4
4
EG004
Step1 HIV Negative
Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.
0
3
0
3
2
3
EG005
Step 2 Arm 1: Fiebig I/II
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody) that enrolled to Step 2.
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
1
26
6
26
18
26
EG006
Step 2 Arm 2: Fiebig III/IV
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2) that enrolled to Step 2.
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
0
42
4
42
30
42
EG007
Step 2 Arm 3: Fiebig V
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band) that enrolled to Step 2.
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
0
23
3
23
15
23
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial infarction
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected26 at risk
EG0060 affected42 at risk
EG0070 affected23 at risk
Pericarditis
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Large intestinal ulcer
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Rectal fissure
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
COVID-19
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Escherichia pyelonephritis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Fascial infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Groin abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Hepatitis A
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Lymphadenitis bacterial
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Monkeypox
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Pneumococcal sepsis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Secondary syphilis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Hepatitis B surface antigen positive
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Cervical cord compression
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Headache
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Adjustment disorder with depressed mood
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Substance-induced psychotic disorder
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0002 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Vascular skin disorder
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected26 at risk
EG0061 affected42 at risk
EG0070 affected23 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Tachycardia paroxysmal
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Thalassaemia
Congenital, familial and genetic disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Chalazion
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Anogenital dysplasia
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0002 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Fatigue
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0012 affected79 at risk
EG0020 affected60 at risk
EG003
Pain
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Pyrexia
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Acute hepatitis C
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0002 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Anal chlamydia infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0004 affected49 at risk
EG0010 affected79 at risk
EG0022 affected60 at risk
EG003
Anal gonococcal infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Bacterial diarrhoea
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Balanitis candida
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Body tinea
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
COVID-19
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0022 affected60 at risk
EG003
Chlamydial cervicitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Genital herpes simplex
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0012 affected79 at risk
EG0020 affected60 at risk
EG003
Genitourinary chlamydia infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Genitourinary tract gonococcal infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Helicobacter gastritis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Hepatitis A
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Hepatitis C
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Herpes simplex anorectal
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Large intestine infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Latent syphilis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0004 affected49 at risk
EG0012 affected79 at risk
EG0021 affected60 at risk
EG003
Latent tuberculosis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Molluscum contagiosum
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Monkeypox
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Neurosyphilis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Oropharyngeal gonococcal infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0004 affected49 at risk
EG0011 affected79 at risk
EG0023 affected60 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Pharyngeal chlamydia infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Primary syphilis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0002 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Proctitis chlamydial
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Proctitis gonococcal
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0013 affected79 at risk
EG0023 affected60 at risk
EG003
Scabies
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Secondary syphilis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0004 affected49 at risk
EG0015 affected79 at risk
EG0023 affected60 at risk
EG003
Shigella infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Sinusitis bacterial
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Syphilis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Syphilis genital
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0002 affected49 at risk
EG0013 affected79 at risk
EG0021 affected60 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Tonsillitis bacterial
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Trichomoniasis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Tubo-ovarian abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Urethritis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Urethritis chlamydial
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0011 affected79 at risk
EG0022 affected60 at risk
EG003
Urethritis gonococcal
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Urethritis ureaplasmal
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0002 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0012 affected79 at risk
EG0020 affected60 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Vulvovaginitis gonococcal
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0006 affected49 at risk
EG0015 affected79 at risk
EG0022 affected60 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0005 affected49 at risk
EG0015 affected79 at risk
EG0024 affected60 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0002 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Blood creatine increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 28.0
Systematic Assessment
EG00016 affected49 at risk
EG00123 affected79 at risk
EG00216 affected60 at risk
EG003
Blood glucose decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Blood glucose increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0013 affected79 at risk
EG0021 affected60 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Blood pressure increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Chlamydia test positive
Investigations
MedDRA 28.0
Systematic Assessment
EG0002 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG00037 affected49 at risk
EG00161 affected79 at risk
EG00245 affected60 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0005 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Neisseria test positive
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0022 affected60 at risk
EG003
Platelet count decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Syphilis test positive
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Trichomonal test positive
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Tuberculin test positive
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Weight decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0002 affected49 at risk
EG0011 affected79 at risk
EG0022 affected60 at risk
EG003
Abnormal loss of weight
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0002 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Vitamin B complex deficiency
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Facet joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Sacral pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Anal papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Anogenital warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0012 affected79 at risk
EG0020 affected60 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Headache
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0002 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Tremor
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Adjustment disorder with mixed anxiety and depressed mood
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Agitated depression
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0002 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Depression
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0011 affected79 at risk
EG0021 affected60 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0022 affected60 at risk
EG003
Mixed anxiety and depressive disorder
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Penile discharge
Reproductive system and breast disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Testicular swelling
Reproductive system and breast disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0021 affected60 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Dyshidrotic eczema
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Penile ulceration
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected79 at risk
EG0020 affected60 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Essential hypertension
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected79 at risk
EG0020 affected60 at risk
EG003
Hypertension
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0002 affected49 at risk
EG0012 affected79 at risk
EG0021 affected60 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Point of Contact
Title
Organization
Phone
Extension
Email
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company
bictegravir, emtricitabine, tenofovir alafenamide, drug combination
D000069545
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Ancestor Terms
ID
Term
D000069547
Cobicistat
D002219
Carbamates
D000144
Acids, Acyclic
D002264
Carboxylic Acids
D009930
Organic Chemicals
D000068698
Tenofovir
D063065
Organophosphonates
D009943
Organophosphorus Compounds
D013844
Thiazoles
D013457
Sulfur Compounds
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D000068679
Emtricitabine
D003841
Deoxycytidine
D003562
Cytidine
D011741
Pyrimidine Nucleosides
D011743
Pyrimidines
D000225
Adenine
D011687
Purines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D003853
Deoxyribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D004338
Drug Combinations
D004364
Pharmaceutical Preparations
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
0 subjects
0 subjects
0 subjects
0 subjects
0 subjects
0 subjects
0 subjects
0 subjects
0 subjects
0 subjects
0 subjects
FG0040 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Unexpected Closure of Site
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Incarceration
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
4
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG00026(22 to 35)
BG00130(24 to 40)
BG00226(23 to 38)
BG00336(22 to 48)
BG00425(19 to 39)
BG00527(23 to 39)
60
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG00031
BG00139
BG00236
BG0032
BG0042
BG005110
30-39 years
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG00260
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG00012
BG00118
BG00212
BG003
40-49 years
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG00260
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG0004
BG00112
BG0026
BG003
50+ years
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG00260
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG0002
BG00110
BG0026
BG003
60
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG00047
BG00173
BG00260
BG0034
BG0042
BG005186
Transgender Spectrum
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG00260
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG0001
BG0015
BG0020
BG003
Not Reported
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG00260
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG0001
BG0011
BG0020
BG003
60
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
Female
BG0004
BG00112
BG00211
BG0032
BG0041
BG00530
Male
BG00045
BG00167
BG00249
BG0032
BG004
60
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
Hispanic or Latino
BG00017
BG00130
BG00218
BG0031
BG0042
BG00568
Not Hispanic or Latino
BG00032
BG00148
BG00242
BG0033
BG004
Unknown or Not Reported
BG0000
BG0011
BG0020
BG0030
BG004
60
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Asian
BG00012
BG0011
BG0021
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG00019
BG00135
BG00239
BG0033
BG004
White
BG00014
BG00136
BG00216
BG0030
BG004
More than one race
BG0000
BG0010
BG0020
BG0031
BG004
Unknown or Not Reported
BG0004
BG0017
BG0024
BG0030
BG004
60
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG00025
BG00165
BG00242
BG0031
BG0040
BG005133
Malawi
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG00260
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG0004
BG0013
BG0023
BG003
Brazil
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG00260
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG0006
BG00110
BG0028
BG003
Zimbabwe
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG00260
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG0000
BG0010
BG0026
BG003
Thailand
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG00260
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG00012
BG0011
BG0020
BG003
Peru
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG00260
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG0002
BG0010
BG0021
BG003
60
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG00022.5(20.3 to 25.6)
BG00125.9(21.4 to 28.8)
BG00223.8(21.4 to 28.2)
BG00322.7(17.7 to 28.4)
BG00423.2(19.4 to 26.1)
BG00524.0(21.2 to 28.0)
60
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG0006.4(5.3 to 7.0)
BG0016.5(6.0 to 7.0)
BG0025.4(5.0 to 6.4)
BG0035.0(3.0 to 6.3)
BG0041.6(1.6 to 1.6)
BG0056.2(5.2 to 6.8)
60
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
<40 copies per mL
BG0000
BG0010
BG0021
BG0031
BG0043
BG0055
40 - <1000 copies per mL
BG0001
BG0010
BG0020
BG0030
BG004
1000 - <10,000 copies per mL
BG0000
BG0012
BG0026
BG0030
BG004
10,000 - <100,000 copies per mL
BG0009
BG0014
BG00210
BG0031
BG004
100,000 - <1,000,000 copies per mL
BG0009
BG00113
BG00223
BG0031
BG004
1,000,000 - <10,000,000 copies per mL
BG00017
BG00139
BG00216
BG0030
BG004
>= 10,000,000 copies per mL
BG00013
BG00121
BG0024
BG0031
BG004
60
ParticipantsBG0034
ParticipantsBG0042
ParticipantsBG005192
Title
Measurements
BG000348(211 to 493)
BG001383(264 to 538)
BG002490(366 to 652)
BG003436(401 to 647)
BG0041090(604 to 1576)
BG005406(284 to 575)
59
ParticipantsBG0034
ParticipantsBG0042
ParticipantsBG005188
Title
Measurements
BG000322(176 to 463)
BG001544(309 to 923)
BG0021016(766 to 1777)
BG0031401(932 to 1843)
BG004474(372 to 575)
BG005613(336 to 1030)
60
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG0007739(219 to 28351)
BG00115440(3716 to 34658)
BG00210104(1333 to 29716)
BG0034575(0 to 9533)
BG0040(0 to 0)
BG00510507(1759 to 29499)
Gag Assay
ParticipantsBG00049
ParticipantsBG00179
ParticipantsBG00260
ParticipantsBG0034
ParticipantsBG0043
ParticipantsBG005195
Title
Measurements
BG0004455(1183 to 11782)
BG0016357(2794 to 17213)
BG0025388(2270 to 12938)
BG003
Title
Measurements
OG0000.10(0.03 to 0.24)
OG0010.06(0.02 to 0.15)
OG0020.10(0.03 to 0.22)
Gag Assay
Title
Measurements
OG0000.03(0.00 to 0.13)
OG0010.02(0.00 to 0.08)
OG0020.00(0.00 to 0.07)
Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.
Fisher Exact
1
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG001
OG002
Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.
Fisher Exact
0.50
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG001
Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.
Fisher Exact
1
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG002
Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.
Fisher Exact
0.44
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG001
OG002
Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.
Fisher Exact
1
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG001
Arm 2: Fiebig III/IV
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
OG002
Arm 3: Fiebig V
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
Units
Counts
Participants
OG00037
OG00160
OG00246
Title
Denominators
Categories
CD4+ T-cell Response to Env
Title
Measurements
OG0000.00(0.00 to 0.24)
OG0010.00(0.00 to 0.09)
OG0020.08(0.00 to 0.17)
CD4+ T-cell Response to Gag
Title
Measurements
OG0000.06(0.00 to 0.23)
OG0010.19(0.03 to 0.31)
OG0020.14(0.05 to 0.27)
CD4+ T-cell Response to Nef
Title
Measurements
OG0000.04(0.00 to 0.15)
OG0010.10(0.00 to 0.26)
OG0020.10(0.00 to 0.23)
CD4+ T-cell Response to Pol
Title
Measurements
OG0000.00(0.00 to 0.03)
OG0010.04(0.00 to 0.13)
OG0020.04(0.00 to 0.19)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.
Wilcoxon (Mann-Whitney)
0.39
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG002
Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.
Wilcoxon (Mann-Whitney)
0.46
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG001
OG002
Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.
Wilcoxon (Mann-Whitney)
0.056
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG001
Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.
Wilcoxon (Mann-Whitney)
0.025
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG002
Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.
Wilcoxon (Mann-Whitney)
0.072
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG001
OG002
Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.
Wilcoxon (Mann-Whitney)
0.47
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG001
Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.
Wilcoxon (Mann-Whitney)
0.086
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG002
Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.
Wilcoxon (Mann-Whitney)
0.18
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG001
OG002
Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.
Wilcoxon (Mann-Whitney)
0.88
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG001
Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.
Wilcoxon (Mann-Whitney)
0.061
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG002
Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.
Wilcoxon (Mann-Whitney)
0.042
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG001
OG002
Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.
Wilcoxon (Mann-Whitney)
0.54
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG001
Arm 2: Fiebig III/IV
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
OG002
Arm 3: Fiebig V
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
Units
Counts
Participants
OG00037
OG00160
OG00246
Title
Denominators
Categories
CD8+ T-cell Response to Env
Title
Measurements
OG0000.00(0.00 to 0.03)
OG0010.00(0.00 to 0.08)
OG0020.00(0.00 to 0.36)
CD8+ T-cell Response to Gag
Title
Measurements
OG0000.15(0.00 to 0.36)
OG0010.33(0.06 to 0.67)
OG0020.28(0.00 to 0.61)
CD8+ T-cell Response to Nef
Title
Measurements
OG0000.03(0.00 to 0.32)
OG0010.15(0.00 to 0.44)
OG0020.33(0.04 to 0.68)
CD8+ T-cell Response to Pol
Title
Measurements
OG0000.00(0.00 to 0.08)
OG0010.05(0.00 to 0.23)
OG0020.08(0.00 to 0.26)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.
Wilcoxon (Mann-Whitney)
0.97
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG002
Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.
Wilcoxon (Mann-Whitney)
0.21
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG001
OG002
Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.
Wilcoxon (Mann-Whitney)
0.12
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG001
Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.
Wilcoxon (Mann-Whitney)
0.055
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG002
Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.
Wilcoxon (Mann-Whitney)
0.28
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG001
OG002
Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.
Wilcoxon (Mann-Whitney)
0.38
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG001
Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.
Wilcoxon (Mann-Whitney)
0.35
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG002
Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.
Wilcoxon (Mann-Whitney)
0.007
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG001
OG002
Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.
Wilcoxon (Mann-Whitney)
0.045
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG001
Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.
Wilcoxon (Mann-Whitney)
0.085
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG002
Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.
Wilcoxon (Mann-Whitney)
0.044
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG001
OG002
Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.
Wilcoxon (Mann-Whitney)
0.60
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
Arm 2: Fiebig III/IV
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
OG002
Arm 3: Fiebig V
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
Units
Counts
Participants
OG00048
OG00178
OG00260
Title
Denominators
Categories
Joint Assay (Integrase + Gag)
Title
Measurements
OG0000.00(0.00 to 0.07)
OG0010.01(0.00 to 0.07)
OG0020.00(0.00 to 0.06)
Integrase Assay
Title
Measurements
OG0000.04(0.01 to 0.14)
OG0010.03(0.00 to 0.09)
OG0020.07(0.02 to 0.16)
Gag Assay
Title
Measurements
OG0000.00(0.00 to 0.07)
OG0010.01(0.00 to 0.07)
OG0020.00(0.00 to 0.06)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Results from Joint Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.
Fisher Exact
1
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG001
OG002
Results from Joint Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.
Fisher Exact
1
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG001
Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.
Fisher Exact
0.64
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG002
Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.
Fisher Exact
0.69
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG001
OG002
Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.
Fisher Exact
0.40
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG000
OG001
Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.
Fisher Exact
1
No adjustments for multiple comparisons. P-value based on two-sided test.
Superiority
OG001
OG002
Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.
Fisher Exact
1
No adjustments for multiple comparisons. P-value based on two-sided test.