At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1,924 enrolled
Drug / intervention
VRC01 +1 morebiological
Likely dose
Not stated in 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 2b Study to Evaluate the Safety and Efficacy of VRC01 Broadly Neutralizing Monoclonal Antibody in Reducing Acquisition of HIV-1 Infection in Women in Sub-Saharan Africa
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 5, 2015·Updated Feb 23, 2022
In Brief
A Phase 2 clinical trial evaluating VRC01 and Placebo for VRC01 for HIV Infections. Completed, enrolled 1,924 participants across 21 sites in 7 countries.
Detailed Summary
This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected women.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBotswana, Kenya, Malawi, Mozambique, South Africa, Tanzania, Zimbabwe
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartMay 2016
Primary CompletionMar 2021
TodayJul 2026
First PostedOct 5, 2015
Enrollment StartMay 1, 2016
Primary CompletionMar 3, 2021
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 10.7 years ago
Interventions
VRC01biological
Administered by IV infusion; total dose will vary based on participant's weight
Placebo for VRC01biological
Sodium Chloride for Injection USP, 0.9%; administered by IV infusion