At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 80 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 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the Serum and Mucosa of Healthy, HIV-Uninfected Adult Participants
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jun 13, 2016·Updated Mar 20, 2024
In Brief
A Phase 1 clinical trial evaluating VRC01 and VRC01LS for HIV Infections. Completed, enrolled 80 participants across 4 sites in 2 countries.
Detailed Summary
This study will evaluate the safety, pharmacokinetics, and antiviral activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of healthy, HIV-uninfected adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesSouth Africa, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartMar 2017
Primary CompletionJun 2019
TodayJul 2026
First PostedJun 13, 2016
Enrollment StartMar 1, 2017
Primary CompletionJun 5, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.1 years ago
Interventions
VRC01biological
Administered by intravenous (IV) infusion
VRC01LSbiological
Administered by intravenous (IV) infusion