CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
VRC01 +2 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.

Search/NCT02591420
NCT02591420Phase 1Completed
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Safety and Virologic Effect of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), With Broad HIV-1 Neutralizing Activity, Administered Intravenously to Adults During Early Acute HIV Infection

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 29, 2015·Updated Dec 17, 2025

In Brief

A Phase 1 clinical trial evaluating VRC01, Placebo for VRC01, and 1 other intervention for HIV Infections. Completed, enrolled 24 participants across 5 sites in 4 countries.

Detailed Summary

This study will evaluate the safety and virologic effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), alone or in combination with antiretroviral therapy (ART), in adults during early acute HIV infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesKenya, Tanzania, Thailand, Uganda
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 29, 2015
Enrollment StartApr 1, 2016
Primary CompletionMar 15, 2021
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 10.7 years ago

Interventions

VRC01biological

40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump

Placebo for VRC01biological

Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump

Antiretroviral therapy (ART) (regimen will vary within countries and by patient)drug

ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.