At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 23 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.
Safety and Therapeutic Efficacy of the Broadly Neutralizing HIV-1 Specific Monoclonal Antibody VRC01 During Analytic Treatment Interruption in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 27, 2016·Updated Nov 2, 2021
In Brief
A Phase 2 clinical trial evaluating VRC01 and Placebo for VRC01 for HIV Infections. Completed, enrolled 23 participants across 1 site.
Detailed Summary
The study will evaluate the safety and therapeutic efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01), when administered during analytic treatment interruption (ATI), in adults who began antiretroviral therapy (ART) during early acute HIV infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesThailand
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartAug 2016
Primary CompletionAug 2017
TodayJul 2026
First PostedJan 27, 2016
Enrollment StartAug 1, 2016
Primary CompletionAug 4, 2017
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 10.4 years ago
Interventions
VRC01biological
40 mg/kg; administered IV
Placebo for VRC01biological
Sodium Chloride for Injection 0.9%, USP; administered IV