Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum
Official Title
Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention During Pregnancy and Postpartum in Adolescents and Young Women and Their Infants
Acronym
Not provided
Organization
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Status Module
Record Verification Date
Jan 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
Jul 3, 2018Actual
Primary Completion Date
Oct 25, 2023Actual
Completion Date
Feb 24, 2024Actual
First Submitted Date
Dec 18, 2017
First Submission Date that Met QC Criteria
Dec 21, 2017
First Posted Date
Dec 29, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Oct 24, 2024
Results First Submitted that Met QC Criteria
Jan 27, 2025
Results First Posted Date
Feb 19, 2025Actual
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
Jan 27, 2025
Last Update Posted Date
Feb 19, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Collaborators
Name
Class
Gilead Sciences
INDUSTRY
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 purpose of this study was to evaluate the pharmacokinetics, feasibility, acceptability, and safety of a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) as oral daily pre-exposure prophylaxis (PrEP) to prevent HIV during pregnancy and postpartum in adolescents and young women and their infants.
Detailed Description
This study evaluated the pharmacokinetics, feasibility, acceptability, and safety of FTC/TDF as oral daily PrEP to prevent HIV during pregnancy and postpartum in adolescents and young women and their infants. The study was conducted in two consecutive components: 1) Pharmacokinetics (PK) Component and 2) PrEP Comparison Component.
In the PK Component, women enrolled in one of two groups. Group 1 included pregnant women at 14 to 24 weeks' gestation and Group 2 included postpartum women who delivered 6 to 12 weeks prior to enrollment. Both groups received a fixed-dose combination of FTC/TDF administered once daily by direct observation from Day 0 through Week 12.
Mothers in the PK Component had weekly study visits through Week 12. Infants in Group 1, whose mothers enrolled during pregnancy, had study visits at birth and six weeks of life; infants in Group 2, who were enrolled with their mothers 6-12 weeks after birth, had study visits at Week 6 and Week 12. Study visits for mothers and infants in the PK Component included evaluation of drug levels and monitoring for adverse effects.
In the PrEP Comparison Component, pregnant women enrolled in one of two cohorts. Mothers in Cohort 1 chose to initiate PrEP at study entry, and mothers in Cohort 2 declined PrEP at entry. Participants in both Cohorts received a standard of care package of HIV prevention services, a study-specific behavioral risk reduction intervention, and periodic one-way short message service (SMS) messages to promote maternal and child health from Day 0 through Week 26. Cohort 1 opted to also receive daily oral FTC/TDF as PrEP and enhanced adherence support, including weekly two-way SMS messaging and feedback of drug levels with tailored adherence counseling. Participants who changed their mind about using PrEP during study participation were able to subsequently stop PrEP (Cohort 1) or initiate PrEP (Cohort 2/Step 2).
Mothers in the PrEP Comparison Component had regular study visits through delivery and Week 26 (postpartum). Infants in the PrEP Comparison Component had four study visits from birth through week 26 of life. For mothers, study visits included physical examinations, blood and urine collection, vaginal and (optional) rectal swab collection, vaginal secretions collection, ultrasounds, and dual-energy x-ray absorptiometry (DXA) scans. For infants, study visits included physical examinations, rectal swab and blood collection, and DXA scans.
In the PrEP Comparison Component analysis, maternal and infant participants were classified based on their PrEP exposure. The PrEP-exposed group included participants from Cohort 1 (throughout the entire study follow-up) and from Cohort 2/Step 2 (from Step 2 entry to the end of follow-up). The PrEP-unexposed group comprised participants from Cohort 2/Step 1 who did not enroll in Cohort 2/Step 2 (throughout the entire study follow-up) or who enrolled in Cohort 2/Step 2 (from study entry until enrolling in Cohort 2/Step 2).
Conditions Module
Conditions
HIV Infections
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
780Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Maternal PK Component Group 1
Experimental
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
200 mg/300 mg of FTC/TDF administered orally as a fixed-dose combination tablet once daily
Maternal PK Component Group 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Estimated Threshold of Maternal Steady-state Tenofovir Diphosphate (TFV-DP) Concentration Levels Corresponding to Optimal Adherence in the PK Component
TFV-DP concentration levels were measured using dried blood spots (DBS) collected weekly during pregnancy and postpartum. These concentrations accumulated each week, and the plateau observed in the concentration-time curve represents the steady-state TFV-DP concentration, achieved at week 12. Predicted TFV-DP concentration levels for each maternal participant were obtained using a population PK model, and descriptive statistics were generated. The estimated steady-state TFV-DP concentration threshold for optimal adherence during pregnancy and postpartum is the 25th percentile when taking 7 doses per week. For more details, refer to the published paper (PubMed ID: 33341883).
Measured from study week 1 to study week 12 during pregnancy for Maternal PK Component Group 1 and from study week 1 to study week 12 during postpartum for Maternal PK Component Group 2
Proportion of Mothers With Optimal Adherence at Antepartum Study Week 4
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Antepartum study week 4
Proportion of Mothers With Optimal Adherence at Antepartum Study Week 8
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Antepartum study week 8
Proportion of Mothers With Optimal Adherence at Antepartum Study Week 12
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Antepartum study week 12
Secondary Outcomes
Measure
Description
Time Frame
Maternal Median Steady State TFV-DP Concentration Levels at Study Week 12 During Pregnancy and Postpartum
TFV-DP concentration levels were measured using dried blood spots (DBS). Concentrations measured at week 12 represent the steady-state TFV-DP concentration.
Assessed at study Week 12 during pregnancy for Maternal PK Component Group 1 and at study Week 12 during postpartum for Maternal PK Component Group 2
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
PK Component (Groups 1 and 2) Inclusion Criteria:
At study entry, pregnant or recently delivered, in one of the following two enrollment windows:
Group 1: Gestational age of 14 to 24 weeks.
Group 2: 6 to 12 weeks postpartum.
Willing to initiate daily PrEP for 12 weeks under directly observed therapy.
HIV and Hepatitis B negative.
At screening:
Grade 1 or normal alanine transaminase (ALT), hemoglobin (HB), absolute neutrophil count (ANC) and normal creatinine clearance (CrCl).
Negative or trace proteinuria (less than Grade 1).
Normal dipstick urine for glucose (less than Grade 1).
Mother weighs greater than 35 kg.
Intention to stay within the study site's catchment area for at least 12 weeks (or through delivery).
Exclusion Criteria (PK Component and PrEP Comparison Component):
Any current significant uncontrolled, active or chronic disease process.
History of any of the following:
Sickle cell anemia, chronic bleeding, blood transfusion within the past 120 days or other blood dyscrasias
Bone fracture not explained by trauma
Allergy/sensitivity to FTC/TDF or its components
Fetus has a known or suspected major congenital anomaly
Mother has confirmed renal insufficiency, a history of renal parenchymal disease or single kidney
Current use of prohibited medications listed in the protocol
Concurrent participation in any biomedical HIV prevention or investigational drug in an HIV vaccine or microbicide study
Past participation in an HIV vaccine study
Currently taking a PrEP regimen from non-study sources
Any other condition or adverse social situation
Past participation in IMPAACT 2009
PrEP Comparison Component (Cohorts 1 and 2) Inclusion Criteria:
At screening, evidence of a viable singleton pregnancy with gestational age of 32 weeks or less.
Within 14 days prior to study entry, negative HIV RNA test.
HIV and Hepatitis B negative.
At screening:
Grade 1 or normal ALT, HB, ANC and normal CrCl.
Negative or trace proteinuria (less than Grade 1).
Normal dipstick urine for glucose (less than Grade 1).
Intention to stay within the study site's catchment area through 26 weeks postpartum
A cellular phone that is able to receive SMS messages, and for Cohort 1 only, is also able to send SMS messages.
Cohort 1 only: Willingness to take PrEP from pregnancy up to 26 weeks postpartum
Cohort 2 only: Unwillingness to take PrEP from pregnancy up to 26 weeks postpartum
Mother weighs greater than 35 kg
Mother is literate in one or more of the study languages
Accepts Healthy Volunteers
Yes
Sex
Female
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
16 Years
Maximum Age
24 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Benjamin Chi, MD, MSc
University of North Carolina, Chapel Hill
Study Chair
Lynda Stranix-Chibanda, MBChB, MMED
University of Zimbabwe Faculty of Medicine and Health Sciences
Stranix-Chibanda L, Anderson PL, Kacanek D, Hosek S, Huang S, Nematadzira TG, Taulo F, Korutaro V, Nakabiito C, Masenya M, Lypen K, Brown E, Ibrahim ME, Yager J, Wiesner L, Johnston B, Amico KR, Rooney JF, Chakhtoura N, Spiegel HML, Chi BH; IMPAACT 2009 Team. Tenofovir Diphosphate Concentrations in Dried Blood Spots From Pregnant and Postpartum Adolescent and Young Women Receiving Daily Observed Pre-exposure Prophylaxis in Sub-Saharan Africa. Clin Infect Dis. 2021 Oct 5;73(7):e1893-e1900. doi: 10.1093/cid/ciaa1872.
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 International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
Access Criteria
With whom?
Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.
For what types of analyses?
To achieve aims in the proposal approved by the IMPAACT Network.
By what mechanism will data be made available?
Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Maternal PK Component Group 1
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
FG001
Maternal PK Component Group 2
Periods
Title
Milestones
Reasons Not Completed
PK Component
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_ICF
Yes
No
Yes
Study Protocol and Informed Consent Form
Nov 19, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
Infants born to women in PK Component Group 1. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
Infant PK Component Group 2
No Intervention
Infants born to women in PK Component Group 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through breastmilk transfer.
Infant PrEP Comparison Cohort 1
No Intervention
Infants born to women in PrEP Comparison Cohort 1. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
Infant PrEP Comparison Cohort 2/Step 1
No Intervention
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study.
Infant PrEP Comparison Cohort 2/Step 2
No Intervention
Infants born to women in PrEP Comparison Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
Maternal PK Component Group 2
Maternal PrEP Comparison Cohort 1
Maternal PrEP Comparison Cohort 2/Step 2
Truvada
Behavioral HIV risk reduction package
Behavioral
Included cohort-appropriate SMS messages.
Maternal PrEP Comparison Cohort 1
Maternal PrEP Comparison Cohort 2/Step 1
Maternal PrEP Comparison Cohort 2/Step 2
Enhanced adherence support
Behavioral
Included two-way SMS messaging and tailored counseling with drug level feedback.
Maternal PrEP Comparison Cohort 1
Maternal PrEP Comparison Cohort 2/Step 2
Proportion of Mothers With Optimal Adherence at Delivery
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Delivery
Proportion of Mothers With Optimal Adherence at Postpartum Week 6
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Postpartum Week 6
Proportion of Mothers With Optimal Adherence at Postpartum Week 14
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Postpartum week 14
Proportion of Mothers With Optimal Adherence at Postpartum Week 26
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Postpartum Week 26
Proportion of Maternal Visits With Optimal Adherence During Study Follow-up
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Study entry through 26 weeks postpartum, up to one year
Incidence Rate of Maternal Adverse Events Per 100 Person-years
Adverse events (AEs) were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. Maternal AEs were defined as the occurrence of at least one grade 2 (moderate) chemistry abnormality, or one grade 3 (severe), grade 4 (potentially life-threatening), or grade 5 (death) adverse event, during the study follow-up.
Study entry through 26 weeks postpartum, up to one year
Number of Composite Adverse Pregnancy Outcomes
Adverse outcomes are defined as at least one of the following: spontaneous abortion (less than 20 weeks gestation), stillbirth (greater than or equal to 20 weeks gestation), preterm delivery (less than 37 weeks), or small for gestational age (less than 10th percentile using INTERGROWTH-21 norms)
Measured at delivery
Incidence Rate of Infant Grade 3 or Higher Adverse Events Per 100 Person-years
Adverse events were assessed according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. An infant grade 3 or higher adverse event was defined as a grade 3 (severe), grade 4 (potentially life-threatening), or grade 5 (death) adverse event.
From birth through week 26
Mean Infant Bone Mineral Content of Whole Body at Birth
Infant bone mineral content was measured by a dual-energy x-ray absorptiometry (DXA) scan of the whole body (WB-BMC)
Measured at birth
Mean Infant Bone Mineral Content of Lumbar Spine at Birth
Infant bone mineral content was measured by a dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine (LS-BMC)
Measured at birth
Mean Infant Bone Mineral Content of Lumbar Spine at Week 26
Infant bone mineral content was measured by a dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine (LS-BMC)
Measured at week 26 post-birth
Mean Infant Creatinine Levels at Birth in the PrEP Comparison Component
Infant creatinine levels were obtained from the chemistry/hematology test results at the birth visit
Measured at birth
Mean Infant Creatinine Levels at Week 26 in the PrEP Comparison Component
Infant creatinine levels were obtained from the chemistry/hematology test results at week 26 visit
Measured at week 26 post-birth
Mean Infant Creatinine Clearance (CrCl) Rate at Birth in the PrEP Comparison Component
The infant creatinine clearance (CrCl) rate was calculated using creatinine levels and length based on the Schwartz equation.
Measured at birth
Mean Infant Creatinine Clearance (CrCl) Rate at Week 26 in the PrEP Comparison Component
The infant creatinine clearance (CrCl) rate was calculated using creatinine levels and length based on the Schwartz equation.
Measured at week 26 post-birth
Mean Infant Length-for-age Z-score at Birth
The infant length-for-age Z-score was calculated based on the infant's sex, length, and age (in days) using WHO child growth standards. The Z-scores range from a minimum of -6 to a maximum of +6. Higher Z-scores indicate better outcomes, reflecting closer adherence to the WHO standards for infant length-for-age. A Z-score of 0 means that the infant's length is exactly at the mean length of the reference population. Z-score between -2 and +2 is considered normal or average. Infants within this range are typically seen as having an appropriate length for their age. Z-score < -3 is a threshold to identify severe stunting, indicating that the infant's length is significantly below the average and pointing to severe chronic undernutrition or other serious health concerns.
Measured at birth
Mean Infant Length-for-age Z-score at Week 26
The infant length-for-age z-score was calculated based on the infant's sex, length, and age (in days) using WHO child growth standards. The z-scores range from a minimum of -6 to a maximum of +6. Higher z-scores indicate better outcomes, reflecting closer adherence to the WHO standards for infant length-for-age. A Z-score of 0 means that the infant's length is exactly at the mean length of the reference population. Z-score between -2 and +2 is considered normal or average. Infants within this range are typically seen as having an appropriate length for their age. Z-score < -3 is a threshold to identify severe stunting, indicating that the infant's length is significantly below the average and pointing to severe chronic undernutrition or other serious health concerns.
Measured at week 26 post-birth
Johannesburg
Gauteng
2001
South Africa
Baylor-Uganda CRS
Kampala
Uganda
MU-JHU Care Limited CRS
Kampala
Uganda
St Mary's CRS
Saint Mary's
Chitungwiza
Zimbabwe
Seke North CRS
Chitungwiza
Zimbabwe
Harare Family Care CRS
Harare
Zimbabwe
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, July 2017
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
FG002
Maternal PrEP Comparison Cohort 1
Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
FG003
Maternal PrEP Comparison Cohort 2/Step 1
Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
FG004
Maternal PrEP Comparison Cohort 2/Step 2
Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
FG005
Infant PK Component Group 1
Infants born to women in PK Component Group 1. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
FG006
Infant PK Component Group 2
Infants born to women in PK Component Group 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through breastmilk transfer.
FG007
Infant PrEP Comparison Cohort 1
Infants born to women in PrEP Comparison Cohort 1. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
FG008
Infant PrEP Comparison Cohort 2/Step 1
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study.
FG009
Infant PrEP Comparison Cohort 2/Step 2
Infants born to women in PrEP Comparison Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
FG00020 subjects
FG00120 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00520 subjects
FG00620 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG00020 subjects
FG00119 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00518 subjects
FG00619 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Stillbirth/Abortion
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
PrEP Comparison Component Step 1
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG002229 subjects
FG003121 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG007229 subjects
FG008121 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG002202 subjects
FG00395 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00227 subjects
FG00326 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG00217 subjects
FG003
PrEP Comparison Component Step 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00413 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00913 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
In the PrEP Comparison Component, baseline characteristics are summarized at enrollment into Cohort 1 or Cohort 2/Step 1. The study was primarily designed to enroll pregnant women, with infants being born during the course of the study. Therefore, the baseline analysis population only includes pregnant women at the time of enrollment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Maternal PK Component Group 1
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
BG001
Maternal PK Component Group 2
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
BG002
Maternal PrEP Comparison Cohort 1
Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
BG003
Maternal PrEP Comparison Cohort 2/Step 1
Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
BG004
Maternal PrEP Comparison Cohort 2/Step 2
Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00020
BG00120
BG002229
BG003121
BG0040
BG005390
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Baseline age is reported separately for PK Component and PrEP Comparison Component participants.
Median
Full Range
years
Title
Denominators
Categories
PK Component
ParticipantsBG00020
ParticipantsBG00120
ParticipantsBG0020
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG00020
ParticipantsBG00120
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00020
ParticipantsBG00120
ParticipantsBG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Malawi
ParticipantsBG00020
ParticipantsBG00120
ParticipantsBG002
Gestational Age
Baseline gestational age is reported separately for PK Component and PrEP Comparison Component participants. PK Component Group 2 participants were enrolled during postpartum.
Median
Full Range
weeks
Title
Denominators
Categories
PK Component
ParticipantsBG00020
ParticipantsBG0010
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
Estimated Threshold of Maternal Steady-state Tenofovir Diphosphate (TFV-DP) Concentration Levels Corresponding to Optimal Adherence in the PK Component
TFV-DP concentration levels were measured using dried blood spots (DBS) collected weekly during pregnancy and postpartum. These concentrations accumulated each week, and the plateau observed in the concentration-time curve represents the steady-state TFV-DP concentration, achieved at week 12. Predicted TFV-DP concentration levels for each maternal participant were obtained using a population PK model, and descriptive statistics were generated. The estimated steady-state TFV-DP concentration threshold for optimal adherence during pregnancy and postpartum is the 25th percentile when taking 7 doses per week. For more details, refer to the published paper (PubMed ID: 33341883).
Mothers from PK Component were included in this outcome measure.
Posted
Number
fmol/punch
Measured from study week 1 to study week 12 during pregnancy for Maternal PK Component Group 1 and from study week 1 to study week 12 during postpartum for Maternal PK Component Group 2
ID
Title
Description
OG000
Maternal PK Component Group 1
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
OG001
Maternal PK Component Group 2
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
Units
Counts
Participants
OG00020
OG00120
Title
Denominators
Categories
Title
Measurements
OG000965
OG0011050
Primary
Proportion of Mothers With Optimal Adherence at Antepartum Study Week 4
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) who were formally prescribed PrEP and had available PK data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
Posted
Number
95% Confidence Interval
proportion of participants
Antepartum study week 4
ID
Title
Description
OG000
Maternal PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Cohort 1: Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
Cohort 2/Step 2: Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
Cohort 2/Step 1: Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
Primary
Proportion of Mothers With Optimal Adherence at Antepartum Study Week 8
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) who were formally prescribed PrEP and had available PK data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
Posted
Number
95% Confidence Interval
proportion of participants
Antepartum study week 8
ID
Title
Description
OG000
PrEP Comparison: PrEP Exposed (Cohort 1 and Cohort 2/Step 2)
Cohort 1: Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
Cohort 2/Step 2: Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
OG001
PrEP Comparison: PrEP Unexposed (Cohort 2/Step 1)
Cohort 2/Step 1: Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
Primary
Proportion of Mothers With Optimal Adherence at Antepartum Study Week 12
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) who were formally prescribed PrEP and had available PK data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
Posted
Number
95% Confidence Interval
proportion of participants
Antepartum study week 12
ID
Title
Description
OG000
Maternal PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Cohort 1: Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
Cohort 2/Step 2: Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
Cohort 2/Step 1: Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
Primary
Proportion of Mothers With Optimal Adherence at Delivery
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) who were formally prescribed PrEP and had available PK data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
Posted
Number
95% Confidence Interval
proportion of participants
Delivery
ID
Title
Description
OG000
Maternal PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Cohort 1: Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
Cohort 2/Step 2: Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
Cohort 2/Step 1: Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
Primary
Proportion of Mothers With Optimal Adherence at Postpartum Week 6
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) who were formally prescribed PrEP and had available PK data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
Posted
Number
95% Confidence Interval
proportion of participants
Postpartum Week 6
ID
Title
Description
OG000
Maternal PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Cohort 1: Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
Cohort 2/Step 2: Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
Cohort 2/Step 1: Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
Primary
Proportion of Mothers With Optimal Adherence at Postpartum Week 14
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) who were formally prescribed PrEP and had available PK data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
Posted
Number
95% Confidence Interval
proportion of participants
Postpartum week 14
ID
Title
Description
OG000
Maternal PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Cohort 1: Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
Cohort 2/Step 2: Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
Cohort 2/Step 1: Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
Primary
Proportion of Mothers With Optimal Adherence at Postpartum Week 26
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) who were formally prescribed PrEP and had available PK data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
Posted
Number
95% Confidence Interval
proportion of participants
Postpartum Week 26
ID
Title
Description
OG000
Maternal PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Cohort 1: Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
Cohort 2/Step 2: Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
Cohort 2/Step 1: Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
Primary
Proportion of Maternal Visits With Optimal Adherence During Study Follow-up
TFV-DP concentration levels were measured using dried blood spots (DBS). Mothers with optimal adherence were identified based on TFV-DP concentration levels and the threshold established in the PK Component.
Mothers from the PrEP Comparison PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) with PK data from any study visits were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
Posted
Number
95% Confidence Interval
proportion of visits
Study entry through 26 weeks postpartum, up to one year
Visits
Visits
ID
Title
Description
OG000
Maternal PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Cohort 1: Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
Cohort 2/Step 2: Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
Cohort 2/Step 1: Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
Primary
Incidence Rate of Maternal Adverse Events Per 100 Person-years
Adverse events (AEs) were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. Maternal AEs were defined as the occurrence of at least one grade 2 (moderate) chemistry abnormality, or one grade 3 (severe), grade 4 (potentially life-threatening), or grade 5 (death) adverse event, during the study follow-up.
Mothers from the PrEP Comparison Component were included in the analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group. The incidence of adverse events was calculated per 100 person-years. Maternal participants in Cohort 2/Step 2 contributed to person-years for both groups, with Cohort 2/Step 1 censored upon enrollment in Step 2.
Posted
Number
95% Confidence Interval
number of new cases per 100 person years
Study entry through 26 weeks postpartum, up to one year
ID
Title
Description
OG000
Maternal PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Cohort 1: Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
Cohort 2/Step 2: Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
Primary
Number of Composite Adverse Pregnancy Outcomes
Adverse outcomes are defined as at least one of the following: spontaneous abortion (less than 20 weeks gestation), stillbirth (greater than or equal to 20 weeks gestation), preterm delivery (less than 37 weeks), or small for gestational age (less than 10th percentile using INTERGROWTH-21 norms)
Mothers from PrEP Comparison Component with available pregnancy outcome data were included in this analysis. All primary analyses, as described in the SAP, were conducted by two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 together were defined as the PrEP-exposed group and were analyzed together.
Posted
Number
participants
Measured at delivery
ID
Title
Description
OG000
Maternal PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Cohort 1: Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
Cohort 2/Step 2: Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
Cohort 2/Step 1: Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
Primary
Incidence Rate of Infant Grade 3 or Higher Adverse Events Per 100 Person-years
Adverse events were assessed according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. An infant grade 3 or higher adverse event was defined as a grade 3 (severe), grade 4 (potentially life-threatening), or grade 5 (death) adverse event.
Live-born infants from PrEP Comparison Component were included in the analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group. The incidence of adverse events was calculated per 100 person-years. Infant participants in Cohort 2/Step 2 contributed to person-years for both groups, with Cohort 2/Step 1 censored upon enrollment in Step 2.
Posted
Number
95% Confidence Interval
number of new cases per 100 person years
From birth through week 26
ID
Title
Description
OG000
Infant PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Infants born to women in PrEP Comparison Cohort 1 or Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study.
Primary
Mean Infant Bone Mineral Content of Whole Body at Birth
Infant bone mineral content was measured by a dual-energy x-ray absorptiometry (DXA) scan of the whole body (WB-BMC)
Infants from PrEP Comparison Component with available DXA data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
Posted
Mean
Standard Deviation
gram
Measured at birth
ID
Title
Description
OG000
Infant PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Infants born to women in PrEP Comparison Cohort 1 or Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study.
Units
Counts
Participants
Primary
Mean Infant Bone Mineral Content of Lumbar Spine at Birth
Infant bone mineral content was measured by a dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine (LS-BMC)
Infants from PrEP Comparison Component with available DXA data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
Posted
Mean
Standard Deviation
gram
Measured at birth
ID
Title
Description
OG000
Infant PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Infants born to women in PrEP Comparison Cohort 1 or Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study.
Units
Counts
Participants
Primary
Mean Infant Bone Mineral Content of Lumbar Spine at Week 26
Infant bone mineral content was measured by a dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine (LS-BMC)
Infants from PrEP Comparison Component with available DXA data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
Posted
Mean
Standard Deviation
gram
Measured at week 26 post-birth
ID
Title
Description
OG000
Infant PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Infants born to women in PrEP Comparison Cohort 1 or Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study.
Units
Counts
Participants
Primary
Mean Infant Creatinine Levels at Birth in the PrEP Comparison Component
Infant creatinine levels were obtained from the chemistry/hematology test results at the birth visit
Infants from PrEP Comparison Component with available creatinine data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
Posted
Mean
Standard Deviation
mg/dL
Measured at birth
ID
Title
Description
OG000
Infant PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Infants born to women in PrEP Comparison Cohort 1 or Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study.
Units
Counts
Participants
Primary
Mean Infant Creatinine Levels at Week 26 in the PrEP Comparison Component
Infant creatinine levels were obtained from the chemistry/hematology test results at week 26 visit
Infants from PrEP Comparison Component with available creatinine data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
Posted
Mean
Standard Deviation
mg/dL
Measured at week 26 post-birth
ID
Title
Description
OG000
Infant PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Infants born to women in PrEP Comparison Cohort 1 or Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study.
Units
Counts
Participants
Primary
Mean Infant Creatinine Clearance (CrCl) Rate at Birth in the PrEP Comparison Component
The infant creatinine clearance (CrCl) rate was calculated using creatinine levels and length based on the Schwartz equation.
Infants from PrEP Comparison Component with available creatinine clearance data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
Posted
Mean
Standard Deviation
mL/min
Measured at birth
ID
Title
Description
OG000
Infant PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Infants born to women in PrEP Comparison Cohort 1 or Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study.
Units
Counts
Participants
Primary
Mean Infant Creatinine Clearance (CrCl) Rate at Week 26 in the PrEP Comparison Component
The infant creatinine clearance (CrCl) rate was calculated using creatinine levels and length based on the Schwartz equation.
Infants from PrEP Comparison Component with available creatinine clearance data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
Posted
Mean
Standard Deviation
mL/min
Measured at week 26 post-birth
ID
Title
Description
OG000
Infant PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Infants born to women in PrEP Comparison Cohort 1 or Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study.
Units
Counts
Participants
Primary
Mean Infant Length-for-age Z-score at Birth
The infant length-for-age Z-score was calculated based on the infant's sex, length, and age (in days) using WHO child growth standards. The Z-scores range from a minimum of -6 to a maximum of +6. Higher Z-scores indicate better outcomes, reflecting closer adherence to the WHO standards for infant length-for-age. A Z-score of 0 means that the infant's length is exactly at the mean length of the reference population. Z-score between -2 and +2 is considered normal or average. Infants within this range are typically seen as having an appropriate length for their age. Z-score < -3 is a threshold to identify severe stunting, indicating that the infant's length is significantly below the average and pointing to severe chronic undernutrition or other serious health concerns.
Infants from PrEP Comparison Component with available length-for-age z-score data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
Posted
Mean
Standard Deviation
Z-score
Measured at birth
ID
Title
Description
OG000
Infant PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Infants born to women in PrEP Comparison Cohort 1 or Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
The infant length-for-age z-score was calculated based on the infant's sex, length, and age (in days) using WHO child growth standards. The z-scores range from a minimum of -6 to a maximum of +6. Higher z-scores indicate better outcomes, reflecting closer adherence to the WHO standards for infant length-for-age. A Z-score of 0 means that the infant's length is exactly at the mean length of the reference population. Z-score between -2 and +2 is considered normal or average. Infants within this range are typically seen as having an appropriate length for their age. Z-score < -3 is a threshold to identify severe stunting, indicating that the infant's length is significantly below the average and pointing to severe chronic undernutrition or other serious health concerns.
Infants from PrEP Comparison Component with available length-for-age z-score data were included in this analysis. Primary analyses, as described in the SAP, were conducted in two groups: PrEP-exposed and PrEP-unexposed. Cohort 1 and Cohort 2/Step 2 were combined as the PrEP-exposed group.
Posted
Mean
Standard Deviation
Z-score
Measured at week 26 post-birth
ID
Title
Description
OG000
Infant PrEP Comparison PrEP-Exposed (Cohort 1 and Cohort 2/Step 2)
Infants born to women in PrEP Comparison Cohort 1 or Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
Maternal Median Steady State TFV-DP Concentration Levels at Study Week 12 During Pregnancy and Postpartum
TFV-DP concentration levels were measured using dried blood spots (DBS). Concentrations measured at week 12 represent the steady-state TFV-DP concentration.
Evaluable participants from PK Components were included in the analysis.
Posted
Median
Inter-Quartile Range
fmol/punch
Assessed at study Week 12 during pregnancy for Maternal PK Component Group 1 and at study Week 12 during postpartum for Maternal PK Component Group 2
ID
Title
Description
OG000
Maternal PK Component Group 1
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
OG001
Maternal PK Component Group 2
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
Units
Counts
Participants
Time Frame
For women, adverse events were reported from enrollment to the end of study follow-up (26 weeks postpartum), up to one year. For infants, adverse events were reported from birth to the end of study follow-up (26 weeks after birth).
Description
Grade 3 or higher, serious, and targeted lower grade adverse events (AEs) were reported for all enrolled women and live-born infants using the DAIDS AE Grading Table (July 2017).
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
Maternal PK Component Group 1
Mothers enrolled during singleton pregnancy at 14-24 weeks' gestation received PrEP once daily under direct observation from day 0 through week 12.
0
20
3
20
1
20
EG001
Maternal PK Component Group 2
Mothers enrolled postpartum within 6-12 weeks after delivery received PrEP once daily under direct observation from day 0 through week 12.
0
20
0
20
2
20
EG002
Maternal PrEP Comparison Cohort 1
Mothers who initiated PrEP at study entry received daily oral PrEP, a behavioral HIV risk reduction package and enhanced adherence support from day 0 through postpartum week 26.
1
229
30
229
123
229
EG003
Maternal PrEP Comparison Cohort 2/Step 1
Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
0
121
4
121
46
121
EG004
Maternal PrEP Comparison Cohort 2/Step 2
Mothers from Cohort 2/Step 1 who subsequently chose to initiate PrEP during the study received daily oral PrEP and enhanced adherence support from Step 2 entry through postpartum week 26, along with the behavioral HIV risk reduction package.
0
13
0
13
5
13
EG005
Infant PK Component Group 1
Infants born to women in PK Component Group 1. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
0
18
1
18
1
18
EG006
Infant PK Component Group 2
Infants born to women in PK Component Group 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through breastmilk transfer.
0
20
0
20
4
20
EG007
Infant PrEP Comparison Cohort 1
Infants born to women in PrEP Comparison Cohort 1. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
9
217
26
217
120
217
EG008
Infant PrEP Comparison Cohort 2/Step 1
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study
5
112
8
112
44
112
EG009
Infant PrEP Comparison Cohort 2/Step 2
Infants born to women in PrEP Comparison Cohort 2/Step 2. Infants did not directly receive PrEP, but may have been exposed to PrEP through placental or breastmilk transfer.
0
13
0
13
4
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia of pregnancy
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG0030 affected121 at risk
EG0040 affected13 at risk
EG0050 affected18 at risk
EG0060 affected20 at risk
EG0070 affected217 at risk
EG0080 affected112 at risk
EG0090 affected13 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Birth mark
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Gastroschisis
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Hyperprolactinaemia
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Gastrointestinal necrosis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Haemoperitoneum
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Death neonatal
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Fever neonatal
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Amniotic cavity infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Endometritis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Malaria
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Sepsis neonatal
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Typhoid fever
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Vulvovaginitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Perineal injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Apgar score low
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Progesterone decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Abortion missed
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Cephalo-pelvic disproportion
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0024 affected229 at risk
EG003
Eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Failed induction of labour
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Foetal death
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Foetal distress syndrome
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0024 affected229 at risk
EG003
Foetal growth restriction
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Foetal malpresentation
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Hypoxic ischaemic encephalopathy neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Jaundice neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Oligohydramnios
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Placenta accreta
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Placenta praevia
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Postpartum haemorrhage
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Premature baby
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Premature rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Prolonged labour
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0024 affected229 at risk
EG003
Retained placenta or membranes
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Stillbirth
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Umbilical cord around neck
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Infantile apnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Meconium aspiration syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Neonatal asphyxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Neonatal respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Neonatal respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG0030 affected121 at risk
EG0040 affected13 at risk
EG0050 affected18 at risk
EG0060 affected20 at risk
EG0070 affected217 at risk
EG0080 affected112 at risk
EG0090 affected13 at risk
Anaemia of pregnancy
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Thrombocytopenia neonatal
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Hyperprolactinaemia
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0025 affected229 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0025 affected229 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0024 affected229 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0023 affected229 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0029 affected229 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0024 affected229 at risk
EG003
Infantile colic
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Infantile diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0026 affected229 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0023 affected229 at risk
EG003
Malaise
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Abscess of external ear
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Body tinea
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Breast abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Chlamydial infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0027 affected229 at risk
EG003
Genital ulcer syndrome
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Gynaecological chlamydia infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Impetigo
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Infected skin ulcer
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Malaria
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Mastitis postpartum
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0026 affected229 at risk
EG003
Ophthalmia neonatorum
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Otitis media
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Paronychia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Pelvic inflammatory disease
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Postpartum sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Primary syphilis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Puerperal infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Sepsis neonatal
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Septic rash
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Tinea manuum
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0023 affected229 at risk
EG003
Typhoid fever
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Umbilical sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG00214 affected229 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG00221 affected229 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Vaginitis chlamydial
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Viral rash
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Vulvitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0029 affected229 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Vulvovaginitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Vulvovaginitis chlamydial
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Vulvovaginitis trichomonal
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Genital injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Incision site pain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0023 affected229 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Perineal injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0024 affected229 at risk
EG003
Postoperative wound complication
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Urethral injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Uterine cervical laceration
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Vulvovaginal injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected20 at risk
EG0021 affected229 at risk
EG003
Blood glucose decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Blood pressure increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0023 affected229 at risk
EG003
Body temperature increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Creatinine renal clearance
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected20 at risk
EG0012 affected20 at risk
EG00217 affected229 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Treponema test positive
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Hypoglycaemia neonatal
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Poor feeding infant
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Underweight
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0027 affected229 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0029 affected229 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Neonatal seizure
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Abortion threatened
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Afterbirth pain
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0028 affected229 at risk
EG003
False labour
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Foetal death
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Foetal growth restriction
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Gestational hypertension
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Haemorrhage in pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Hyperemesis gravidarum
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Hypoxic ischaemic encephalopathy neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Jaundice neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Meconium in amniotic fluid
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Morning sickness
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0023 affected229 at risk
EG003
Oligohydramnios
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0023 affected229 at risk
EG003
Postpartum haemorrhage
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Pre-eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Premature baby
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Premature delivery
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Premature labour
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Prolonged rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Stillbirth
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Uterine contractions during pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Abnormal uterine bleeding
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0023 affected229 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Nipple disorder
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Nipple pain
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected229 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0027 affected229 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Neonatal asphyxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Neonatal dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Neonatal respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Eczema infantile
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Erythema toxicum neonatorum
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Exfoliative rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Milia
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Scar pain
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Transient neonatal pustular melanosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Episiotomy
Surgical and medical procedures
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected229 at risk
EG003
Therapeutic procedure
Surgical and medical procedures
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected229 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0026 affected229 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.
Cohort 2/Step 1: Mothers who declined PrEP initiation at study entry received a behavioral HIV risk reduction package from day 0 through postpartum week 26.
Units
Counts
Participants
OG000242
OG001121
Title
Denominators
Categories
Title
Measurements
OG00029.4(22.1 to 36.0)
OG00118.2(11.0 to 30.2)
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
The incidence rate ratio of cumulative maternal adverse events was calculated between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and the PrEP-unexposed (Cohort 2/Step 1) reference group based on incidence per person-time follow-up. Maternal participants in Cohort 2/Step 2 contributed person-time to both Cohort 2/Step 1 and Step 2.
Incidence rate ratio
1.62
2-Sided
95
0.89
2.94
Other
Units
Counts
Participants
OG000216
OG001108
Title
Denominators
Categories
Title
Measurements
OG00051
OG00128
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
Odds ratio comparing the proportion of mothers with adverse pregnancy outcomes between the PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 1) reference group.
Odds Ratio (OR)
0.88
2-Sided
95
0.52
1.50
Other
OG000
OG001
Test the differences in the proportion of mothers with adverse pregnancy outcomes between PrEP-exposed (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 2) groups.
Fisher Exact
0.68
Other
Units
Counts
Participants
OG000230
OG001112
Title
Denominators
Categories
Title
Measurements
OG00042.6(29.6 to 61.2)
OG00133.1(18.4 to 59.7)
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
The incidence rate ratio of cumulative infant AEs between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 1) reference group was based on incidence per person-time follow-up. Cohort 2/Step 2 infants contributed person-time to both Cohort 2/Step 1 and Step 2.
Incidence rate ratio
1.29
2-Sided
95
0.70
2.38
Other
OG000128
OG00174
Title
Denominators
Categories
Title
Measurements
OG00068.2± 13.3
OG00165.8± 12.0
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
A two-sample t-test was used to evaluate the difference in mean infant whole-body bone mineral content (WB-BMC) at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).
t-test, 2 sided
0.18
Other
OG000107
OG00173
Title
Denominators
Categories
Title
Measurements
OG0001.9± 0.5
OG0011.8± 0.4
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
A two-sample t-test was used to evaluate the difference in mean infant lumbar-spine bone mineral content (WB-BMC) at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).
t-test, 2 sided
0.39
Other
OG000131
OG00148
Title
Denominators
Categories
Title
Measurements
OG0003.2± 0.6
OG0013.1± 0.7
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
A two-sample t-test was used to evaluate the difference in mean infant lumbar-spine bone mineral content (WB-BMC) at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).
t-test, 2 sided
0.12
Other
OG000192
OG00195
Title
Denominators
Categories
Title
Measurements
OG0000.4± 0.2
OG0010.3± 0.1
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
A two-sample t-test was used to evaluate the difference in mean infant creatinine levels at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).
t-test, 2 sided
0.70
Other
OG000206
OG00187
Title
Denominators
Categories
Title
Measurements
OG0000.2± 0.0
OG0010.2± 0.0
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
A two-sample t-test was used to evaluate the difference in mean infant creatinine levels at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).
t-test, 2 sided
0.58
Other
OG000192
OG00195
Title
Denominators
Categories
Title
Measurements
OG00084.4± 61.6
OG00174.6± 33.7
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
A two-sample t-test was used to evaluate the difference in mean infant creatinine clearance rate at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).
t-test, 2 sided
0.08
Other
OG000205
OG00186
Title
Denominators
Categories
Title
Measurements
OG000143.3± 42.5
OG001140.1± 37.3
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
A two-sample t-test was used to evaluate the difference in mean infant creatinine clearance rate at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1)
t-test, 2 sided
0.52
Other
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study.
Units
Counts
Participants
OG000197
OG00197
Title
Denominators
Categories
Title
Measurements
OG000-0.4± 1.4
OG001-0.6± 1.2
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
A two-sample t-test was used to evaluate the difference in mean infant length-for-age z-score at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).
t-test, 2 sided
0.30
Other
Infants born to women in PrEP Comparison Cohort 2/Step 1. Infants were not exposed to PrEP during the study.
Units
Counts
Participants
OG000205
OG00187
Title
Denominators
Categories
Title
Measurements
OG000-0.6± 1.2
OG001-0.8± 1.1
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
A two-sample t-test was used to evaluate the difference in mean infant length-for-age z-score at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).