At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
VRC01 +1 morebiological
Likely dose
VRC01 40 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Study to Evaluate the Safety, Tolerability, and Effect of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), on Markers of HIV Persistence in ART-treated, HIV-infected Adults
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Apr 8, 2015·Updated Nov 5, 2021
In Brief
A Phase 1 clinical trial evaluating VRC01 and Placebo for HIV Infections. Completed, enrolled 40 participants across 13 sites.
Detailed Summary
The purpose of this study was to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), in adults infected with HIV who were receiving antiretroviral therapy (ART).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 2015
Enrollment StartAug 2015
Primary CompletionApr 2016
Study CompletionSep 2016
TodayJul 2026
First PostedApr 8, 2015
Enrollment StartAug 25, 2015
Primary CompletionApr 15, 2016
Study CompletionSep 29, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.2 years ago
Interventions
VRC01biological
40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebobiological
Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump