At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
VRC01biological
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, Open-Label Study of the Safety, Pharmacokinetics, and Antiviral Activity of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), With Broad HIV-1 Neutralizing Activity, Administered Intravenously to HIV-Infected Adults Undergoing a Brief Analytical Treatment Interruption
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jun 4, 2015·Updated Oct 19, 2021
In Brief
A Phase 1 clinical trial evaluating VRC01 for HIV Infections. Completed, enrolled 14 participants across 2 sites.
Detailed Summary
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), and antiviral activity of an antibody (called VRC01) in HIV-infected adults whose HIV was well-controlled with HIV medicines. The study examined whether VRC01 controlled or delayed the return of HIV viremia when the participants' HIV medicines were briefly stopped during the study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartAug 2015
Primary CompletionMar 2016
Study CompletionOct 2016
TodayJul 2026
First PostedJun 4, 2015
Enrollment StartAug 1, 2015
Primary CompletionMar 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.1 years ago
Interventions
VRC01biological
40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP. Administered over about 30 to 60 minutes using a volumetric pump.