At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 83 enrolled
Drug / intervention
VRC01 +2 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.
Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous (SC) VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 3, 2014·Updated Feb 8, 2023
In Brief
A Phase 1 clinical trial evaluating VRC01, VRC01LS, and 1 other intervention for HIV Infections. Completed, enrolled 83 participants across 14 sites in 4 countries.
Detailed Summary
The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesPuerto Rico, South Africa, United States, Zimbabwe
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartJun 2015
Primary CompletionJun 2020
Study CompletionDec 2021
TodayJul 2026
First PostedOct 3, 2014
Enrollment StartJun 30, 2015
Primary CompletionJun 17, 2020
Study CompletionDec 16, 2021
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 11.7 years ago
Interventions
VRC01biological
Administered by subcutaneous injection in the thigh
VRC01LSbiological
Administered by subcutaneous injection in the thigh
VRC07-523LSbiological
Administered by subcutaneous injection in the thigh