Evaluating the Safety, Tolerability, and Effect of a Huma... | NCT02411539

NCT02411539

ID	Type	Description	Link
12003	Registry Identifier	DAIDS-ES
UM1AI068636	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	NETWORK

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: VRC01 followed by placebo	Experimental	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo (normal saline) at Weeks 6 and 9.	Biological: VRC01 Biological: Placebo
Arm B: placebo followed by VRC01	Experimental	Participants received an infusion of placebo (normal saline) at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.	Biological: VRC01 Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VRC01	Biological	40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump	Arm A: VRC01 followed by placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Experienced Grade 3 or Greater, Treatment Related, Adverse Event (AE)	Refer to detailed description in the protocol section. Includes signs/symptoms, lab toxicities, and/or clinical events that are possibly, probably, or definitely related to study treatment (as judged by the core team, blinded to treatment arm) at any time from the initial dose of VRC01 to end of study follow-up. This analysis was primarily descriptive and no significance testing was performed.	Measured from study treatment initiation to study discontinuation (study duration is 30 weeks)
Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells	Change from baseline (geometric average of screening and entry results) to week 6 in log10 transformed cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells	Screening, entry and week 6

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Premature Treatment Discontinuation, for Reasons Related to Study Treatment	Study treatment was taken from entry through week 12 - this outcome assesses the number of participants who permanently and prematurely discontinued study treatment due to reasons related to the study treatment	Measured from study treatment initiation to study treatment discontinuation (study treatment dispensed through week 12)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV-1 infection, documented by any FDA-approved rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV or E/CIA tests, or by HIV-1 antigen, or plasma HIV-1 RNA assay. More information on this criterion is available in the protocol.
Received continuous ART for at least 2 years (defined as no interruptions longer than 14 consecutive days) and with no changes in the components of the ART for at least 90 days prior to study entry
CD4+ cell count greater than or equal to 200 cells/mm^3 obtained within 60 days prior to study entry in a clinical laboratory improvement amendments (CLIA)-certified laboratory
Plasma HIV-1 RNA below the limit of detection of the FDA-approved assays (limit of detection: 75, 50, 40 or 20 copies/mL) for greater than or equal to 2 years on ART. Participants must have had at least one documented HIV-1 RNA less than the limit of detection 12-24 months prior to study entry and at least one HIV-1 RNA less than the limit of detection within 12 months prior to study entry. All available HIV-1 RNA measurements must have been below the assay limit of detection during the 2 years prior to study entry except as allowed by the following note. NOTE: A single unconfirmed plasma HIV-1 RNA greater than the limit of detection but less than 200 copies/mL within 6-24 months was allowed if followed by a subsequent value below the limit of detection.
Plasma HIV-1 RNA level of less than 40 copies/mL obtained by the Abbott Real-time HIV assay (m2000) or less than 20 copies/mL obtained by the Roche COBAS Taqman HIV-1 v2.0 assay within 60 days prior to entry
The following laboratory values obtained within 60 days prior to entry by any U.S. laboratory that has a CLIA certification or its equivalent.
- Absolute neutrophil count (ANC) greater than or equal to 750 cells/mm^3
- Hemoglobin greater than or equal to 11.0 g/dL for men and greater than or equal to 10.0 g/dL for women
- Platelet count greater than or equal to 100,000/mm^3
- Creatinine clearance greater than or equal to 60 mL/min estimated by the Cockcroft-Gault equation. NOTE: A program for calculating creatinine clearance by the Cockcroft-Gault method is available on www.fstrf.org.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (SGPT) less than or equal to 2.0 times upper limit of normal (ULN)
Hepatitis C virus (HCV) antibody negative result within 60 days prior to study entry or, if the HCV antibody result is positive, a negative HCV RNA result within 60 days prior to study entry
Negative HBsAg result obtained within 60 days prior to study entry
Ability and willingness of participant to provide informed consent
Females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy, or bilateral oophorectomy and/or bilateral salpingectomy), needed a negative serum or urine pregnancy test within 48 hours prior to study entry. NOTE: Acceptable documentation of hysterectomy and bilateral oophorectomy, bilateral salpingectomy, tubal micro-inserts, partner who has undergone vasectomy, and menopause is participant-reported history.
All participants must have agreed not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the participant/partner must use at least one reliable form of contraception (condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide; an intrauterine device (IUD); or hormone-based contraceptive), while receiving study treatment and for 12 weeks after stopping study treatment
Documentation of the availability of the following stored samples from the screening visit: peripheral blood mononuclear cell (PBMC) for CD4+ T-cell associated HIV-1 RNA, DNA assay and plasma for HIV-1 SCA. Sites must receive confirmation from the processing lab via phone, email, or fax, that specimens have been entered into the AIDS Clinical Trials Group (ACTG) Laboratory Data Management System (LDMS).

Exclusion Criteria:

Previous receipt of humanized or human monoclonal antibody (licensed or investigational)
Weight greater than 115 kg or less than 53 kg
Acute or ongoing AIDS-defining illness within 60 days prior to study entry
History of a severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis within 2 years of study entry
Currently breastfeeding or pregnant
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
Acute or serious illness that, in the opinion of the site investigator, requires systemic treatment and/or hospitalization within 60 days prior to entry
Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry. NOTE: Participants receiving stable physiologic doses of glucocorticoids, defined as the equivalent of prednisone less than or equal to 10 mg/day, will not be excluded. Stable physiologic glucocorticoid doses should not be discontinued for the duration of the study. In addition, participants receiving inhaled or topical corticosteroids will not be excluded.
Treatment for hepatitis C within 24 weeks of study entry
Vaccinations within 7 days prior to the screening, pre-entry, or study entry visits. NOTE: Participants are encouraged to get routine vaccinations, such as seasonal influenza vaccine more than 7 days prior to screening or between screening and pre-entry visits (outside of the 7-day window above).
Initiation of ART during acute HIV-1 infection (as determined by the site investigator by history and/or available medical records)

Contacts/Locations Module

Name	Affiliation	Role
Sharon Riddler, MD, MPH	Pitt CRS	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
UCSD Antiviral Research Center CRS		San Diego	California	92103	United States
University of Colorado Hospital CRS

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30364428	Derived	Riddler SA, Zheng L, Durand CM, Ritz J, Koup RA, Ledgerwood J, Bailer RT, Koletar SL, Eron JJ, Keefer MC, Macatangay BJC, Cyktor JC, Mellors JW; AIDS Clinical Trials Group A5342 Protocol Team. Randomized Clinical Trial to Assess the Impact of the Broadly Neutralizing HIV-1 Monoclonal Antibody VRC01 on HIV-1 Persistence in Individuals on Effective ART. Open Forum Infect Dis. 2018 Oct 20;5(10):ofy242. doi: 10.1093/ofid/ofy242. eCollection 2018 Oct.

Label	URL
To grade diagnoses, signs and symptoms, and laboratory results, sites referred to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 2.0, November 2014	View source

ID	Title	Description
FG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Categories

Title	Measurements
	OG0000 OG0010

Primary

Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells

Change from baseline (geometric average of screening and entry results) to week 6 in log10 transformed cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells

Analysis of participants with available results for the change in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells. All participants received at least one dose of the randomized treatment assigned. No participants received the incorrect treatment.

Posted

Median

Inter-Quartile Range

log10 ratio

Screening, entry and week 6

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Number of Participants With Premature Treatment Discontinuation, for Reasons Related to Study Treatment

Study treatment was taken from entry through week 12 - this outcome assesses the number of participants who permanently and prematurely discontinued study treatment due to reasons related to the study treatment

All participants who received at least one infusion of study treatment

Posted

Count of Participants

Participants

Measured from study treatment initiation to study treatment discontinuation (study treatment dispensed through week 12)

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Last Value Carried Forward (LVCF)

Change from baseline (geometric average of screening and entry results) to week 6 in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells, using a last value carried forward approach if week 6 cell-associated HIV-1 RNA/DNA ratio was missing. In the event that the week 6 value was missing, the week 3 value was carried forward to be used. This comparison is the change from the average of screening and entry results to the week 6 value (if available), and if week 6 result was not available, the week 3 value was used instead of the week 6 value.

Analysis of participants with available results for the change in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells, carrying last available result forward if missing at week 6

Posted

Median

Inter-Quartile Range

log10 ratio

Screening, entry, week 3 and week 6 (week 3 used as LVCF if necessary)

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Across Arms

Summary of within-participant change across treatment arms from the pre-VRC01 time point to the post-VRC01 time point. For Arm A, the pre-VRC01 time point used was the baseline measure (geometric average of screening and entry results) and the post-VRC01 time point was the week 6 measure. For Arm B, the pre-VRC01 time point used was the week 6 measure and the post-VRC01 time point was the week 12 measure. Change in CA-RNA/DNA ratio was calculated on the log10 scale.

Analysis of all participants with available pre- and post-VRC01 cell-associated RNA/DNA ratio results available. Participants from Arm A must have had results at entry and week 6. Participants from Arm B must have had results from week 6 and week 12.

Posted

Median

Inter-Quartile Range

log10 ratio

Screening, entry and weeks 6 and 12

ID	Title	Description
OG000	Across Arms	Compare the pre-VRC01 and post-VRC01 time points across randomized Arms A/B. Arm A participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. Arm B participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. This group is to identify analyses that were assessed across randomized arms between the pre- and post-VRC01 time points.

Units	Counts
Participants

Secondary

Cell-associated HIV-1 RNA in Total CD4+ Cells

Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.

Analysis of participants with available cell-associated HIV-1 RNA results

Posted

Median

Inter-Quartile Range

log10 copies/million CD4

Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Cell-associated HIV-1 DNA in Total CD4+ Cells

Analysis of participants with available cell-associated HIV-1 DNA results

Posted

Median

Inter-Quartile Range

log10 copies/million CD4

Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells

Analysis of participants with available cell-associated HIV-1 RNA/DNA ratio

Posted

Median

Inter-Quartile Range

log10 ratio

Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit

The analysis of HIV-1 RNA SCA assessed the number of participants below the assay lower limit (1 copy/mL) at each measurement week. Specific specimens and time points were targeted based on Arm. Samples were not tested for Arm A at the Week 7 and Week 10 time points. Samples were not tested for Arm B at the Week 1 and Week 4 time points.

Testing of specimens at weeks 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.

Analysis of participants with available SCA results

Posted

Count of Participants

Participants

Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

CD4+ T-cell Counts

Baseline measure represents the average of screening and entry results

Analysis of all participants with available CD4+ results

Posted

Median

Inter-Quartile Range

cells/mm^3

Measured at screening, entry and weeks 6, 12, 18 and 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Units	Counts
Participants

Secondary

CD8+ T-cell Counts

Baseline measure represents the average of screening and entry results

Analysis of all participants with available CD8+ results

Posted

Median

Inter-Quartile Range

cells/mm^3

Measured at screening, entry and weeks 6, 12, 18 and 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Units	Counts
Participants

Secondary

Total/Inducible Virus Recovery - Stimulated HIV-1 RNA

As part of the total virus recovery assay, results for stimulated HIV-1 RNA (copies/mL) are generated

Includes all participants with available stimulated HIV-1 RNA results from virus recovery assay

Posted

Median

Inter-Quartile Range

log10 copies/mL

Measured at pre-entry, week 6 and week 12

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Units	Counts

Secondary

Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA

As part of the total virus recovery assay, results for unstimulated HIV-1 RNA (copies/mL) are generated

Includes all participants with available unstimulated HIV-1 RNA results from virus recovery assay

Posted

Median

Inter-Quartile Range

log10 copies/mL

Measured at pre-entry, week 6 and week 12

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Units	Counts

Secondary

Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio

Includes all participants with available stimulated/unstimulated HIV-1 RNA results from virus recovery assay

Posted

Median

Inter-Quartile Range

ratio

Measured at pre-entry, week 6 and week 12

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Total/Inducible Virus Recovery - Stimulated Cell Fluor

As part of the total virus recovery assay, results for stimulated cell fluor (light units) are generated.

Includes all participants with available stimulated cell fluor results from virus recovery assay

Posted

Median

Inter-Quartile Range

million light units

Measured at pre-entry, week 6 and week 12

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Units	Counts

Secondary

Total/Inducible Virus Recovery - Unstimulated Cell Fluor

As part of the total virus recovery assay, results for unstimulated cell fluor (light units) are generated.

Includes all participants with available unstimulated cell fluor results from virus recovery assay

Posted

Median

Inter-Quartile Range

million light units

Measured at pre-entry, week 6 and week 12

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Units	Counts

Secondary

Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio

Includes all participants with available stimulated/unstimulated cell fluor results from virus recovery assay

Posted

Median

Inter-Quartile Range

ratio

Measured at pre-entry, week 6 and week 12

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Total/Inducible Virus Recovery - Percentage of Total CD4 Yield

As part of the total virus recovery assay, results for %tCD4 yield are generated.

Includes all participants with available %tCD4 yield results from virus recovery assay

Posted

Median

Inter-Quartile Range

percentage of Total CD4 Yield

Measured at pre-entry, week 6 and week 12

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Units	Counts

Secondary

Change in Total/Inducible Virus Recovery - Stimulated HIV-1 RNA

As part of the total virus recovery assay, results for stimulated HIV-1 RNA (copies/mL) are generated. The change from the pre-treatment time point to week 6 was assessed as a fold change (week 6 / pre-entry)

Includes all participants with available stimulated HIV-1 RNA results from virus recovery assay at pre-entry and week 6 time points

Posted

Median

Inter-Quartile Range

fold change

Measured at pre-entry, week 6

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Change in Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA

As part of the total virus recovery assay, results for unstimulated HIV-1 RNA (copies/mL) are generated. The change from the pre-treatment time point to week 6 was assessed as a fold change (week 6 / pre-entry)

Includes all participants with available unstimulated HIV-1 RNA results from virus recovery assay at pre-entry and week 6 time points

Posted

Median

Inter-Quartile Range

fold change

Measured at pre-entry, week 6

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio

As part of the total virus recovery assay, results for stimulated and unstimulated HIV-1 RNA (copies/mL) are generated. At each time point, the ratio of the stimulated to unstimulated HIV-1 RNA was calculated. The fold change of this ratio from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)

Includes all participants with available stimulated/unstimulated HIV-1 RNA results from virus recovery assay

Posted

Median

Inter-Quartile Range

fold change

Measured at pre-entry and week 6

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Change in Total/Inducible Virus Recovery - Stimulated Cell Fluor

As part of the total virus recovery assay, results for stimulated cell fluor (light units) are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)

Includes all participants with available stimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points

Posted

Median

Inter-Quartile Range

fold change

Measured at pre-entry, week 6

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Change in Total/Inducible Virus Recovery - Unstimulated Cell Fluor

As part of the total virus recovery assay, results for unstimulated cell fluor (light units) are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)

Includes all participants with available unstimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points

Posted

Median

Inter-Quartile Range

fold change

Measured at pre-entry, week 6

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio

As part of the total virus recovery assay, results for stimulated and unstimulated cell fluor (light units) are generated. At each time point, the ratio of the stimulated to unstimulated cell fluor was calculated. The fold change of this ratio from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)

Includes all participants with available stimulated/unstimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points

Posted

Median

Inter-Quartile Range

fold change

Measured at pre-entry, week 6

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Change in Total/Inducible Virus Recovery - Percentage of Total CD4 Yield

As part of the total virus recovery assay, results for %tCD4 yield are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)

Includes all participants with available %tCD4 yield results from virus recovery assay at pre-entry and week 6 time points

Posted

Median

Inter-Quartile Range

fold change

Measured at pre-entry, week 6

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

VRC01 Antibody Level

Summarize the pharmacokinetics (PK) of two infusions of VRC01 during study follow up

Specific specimens and time points were targeted for testing based on Arm. Samples for Arm A were not tested for the Week 6 and Week 9 post-infusion time points. Samples for Arm B were not tested for the Week 0 and Week 3 post-infusion time points.

Analysis of all participants with available results.

Posted

Median

Inter-Quartile Range

ug/mL

Measured at entry and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18 and 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo (normal saline) at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo (normal saline) at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Detectability of Antibody to VRC01 as Measured in Serum

Assess the detectability of antibody to VRC01 in samples collected during study follow-up. Intended to be result from specimen at week 30 time point. Due to specimen availability, four participants in Arm A had results from specimens from the week 18 time point. Counts provided are number of participants with detectable anti-VRC01 antibody result.

All participants with results for anti-VRC01 antibody. Two participants did not have results (one from each arm) due to being lost to follow up.

Posted

Count of Participants

Participants

Measured at week 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo (normal saline) at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo (normal saline) at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Levels of T-cell Activation

% CD4+ and CD8+ T-cells co-expressing human leukocyte antigen (HLA)-DR and CD38

Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.

Analysis not performed. See outcome measure description for reasoning.

Posted

Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo (normal saline) at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo (normal saline) at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Levels of NK Cell Activation

% NK cells expressing CD69 or CD95

Analysis not performed. See outcome measure description for reasoning.

Posted

Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Plasma Levels of sCD163

Analysis not performed. See outcome measure description for reasoning.

Posted

Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Plasma Levels of sCD14

Analysis not performed. See outcome measure description for reasoning.

Posted

Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Plasma Levels of Interleukin-6 (IL-6)

Analysis not performed. See outcome measure description for reasoning.

Posted

Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Plasma Levels of Human Soluble Tumor Necrosis Factor Alpha-receptor (sTNFαR)

Analysis not performed. See outcome measure description for reasoning.

Posted

Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Plasma Levels of Tumor Necrosis Factor Alpha (TNFα)

Analysis not performed. See outcome measure description for reasoning.

Posted

Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

Plasma Levels of High-sensitivity C-reactive Protein (hsCRP)

Analysis not performed. See outcome measure description for reasoning.

Posted

Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Secondary

VRC01 Antibody Level Relative to Infusion Timing

Summarize the pharmacokinetics (PK) of two infusions of VRC01 during study follow up - aligning the timing of PK samples/results to the respective VRC01 infusions for each Arm

Analysis of all participants with available results.

Posted

Median

Inter-Quartile Range

ug/mL

Measured immediately after first infusion (and 1, 2, and 3 weeks after), and immediately after second infusion (and 1, 2, 3, 6 and 9 weeks after)

ID	Title	Description
OG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo (normal saline) at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
OG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo (normal saline) at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

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	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump	0	20	0	20	16	20
EG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump	0	20	1	20	17	20

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Syncope	Nervous system disorders	MedDRA 19.1	Systematic Assessment		EG0000 affected20 at risk EG0011 affected20 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Eye movement disorder	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Anogenital dysplasia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected20 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0013 affected20 at risk
Reactive gastropathy	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Chest discomfort	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Chest pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Chills	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0012 affected20 at risk
Fatigue	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0012 affected20 at risk
Influenza like illness	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected20 at risk
Malaise	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected20 at risk
Pyrexia	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected20 at risk
Acute sinusitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Influenza	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Oral herpes	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected20 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected20 at risk
Alanine aminotransferase	Investigations	MedDRA 19.1	Systematic Assessment	EG0002 affected20 at risk EG0010 affected20 at risk
Aspartate aminotransferase	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected20 at risk
Bilirubin conjugated abnormal	Investigations	MedDRA 19.1	Systematic Assessment	EG0002 affected20 at risk EG0010 affected20 at risk
Bilirubin conjugated increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected20 at risk
Blood alkaline phosphatase abnormal	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected20 at risk
Blood bilirubin abnormal	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected20 at risk
Blood bilirubin increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0002 affected20 at risk EG0012 affected20 at risk
Blood creatinine abnormal	Investigations	MedDRA 19.1	Systematic Assessment	EG0002 affected20 at risk EG0013 affected20 at risk
Blood creatinine increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0013 affected20 at risk
Blood glucose increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected20 at risk
Blood potassium decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected20 at risk
Blood potassium increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Blood sodium decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0006 affected20 at risk EG00110 affected20 at risk
Haemoglobin decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected20 at risk
Neutrophil count decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0012 affected20 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected20 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected20 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected20 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected20 at risk EG0011 affected20 at risk
Burning sensation	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Dizziness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected20 at risk
Headache	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0012 affected20 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected20 at risk
Lethargy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Paraesthesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Tremor	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Anxiety	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Insomnia	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Psychogenic seizure	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Genital lesion	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected20 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0014 affected20 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected20 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Pulmonary sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected20 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected20 at risk EG0011 affected20 at risk
Sinus pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected20 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Fixed drug eruption	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected20 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected20 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected20 at risk EG0010 affected20 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected20 at risk
Hot flush	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected20 at risk

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
C578595	VRC01 monoclonal antibody

Units	Counts
Participants	OG00018 OG00119

Units	Counts
Participants	OG00020 OG00120

Units	Counts
Participants	OG00020 OG00120

Units	Counts
Participants	OG00020 OG00120

Units	Counts
Participants	OG00020 OG00120

Units	Counts
Participants	OG00019 OG00119

Units	Counts
Participants	OG00020 OG00120

Units	Counts
Participants	OG0000 OG0010

Units	Counts
Participants	OG0000 OG0010

Units	Counts
Participants	OG0000 OG0010

Units	Counts
Participants	OG00020 OG00120

ID	Title	Description
BG000	Arm A: VRC01 Followed by Placebo	Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
BG001	Arm B: Placebo Followed by VRC01	Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
BG002	Total	Total of all reporting groups