At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 61 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.
Phase I/II Multisite, Randomized, Controlled Study of Monoclonal Antibody VRC01 With Combination Antiretroviral Therapy to Promote Clearance of HIV-1-Infected Cells in Infants
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 5, 2017·Updated May 24, 2023
In Brief
A Phase 2 clinical trial evaluating VRC01 and Combination Antiretroviral Therapy (cART) for HIV Infections. Completed, enrolled 61 participants across 7 sites in 4 countries.
Detailed Summary
The purpose of this study was to evaluate the safety and antiviral activity to promote clearance of HIV-1 infected cells of VRC01 in infants with HIV beginning combination antiretroviral therapy (cART).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBotswana, Brazil, Malawi, Zimbabwe
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 2017
Enrollment StartAug 2018
Primary CompletionJun 2020
Study CompletionFeb 2021
TodayJul 2026
First PostedJul 5, 2017
Enrollment StartAug 6, 2018
Primary CompletionJun 16, 2020
Study CompletionFeb 11, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.0 years ago
Interventions
VRC01biological
40 mg/kg of VRC01 administered by subcutaneous injection.
Combination Antiretroviral Therapy (cART)drug
All infants received non-study provided cART selected by their primary care provider and supplied through non-study sources (i.e., cART not provided through the study).