CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 75 enrolled
Drug / intervention
Oral Cabotegravir (CAB) +4 moredrug
Likely dose
Oral Cabotegravir (CAB) 30 mgfrom 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.

Search/NCT03739996
NCT03739996Phase 2Completed
CompareCT.gov

A Study of Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) to Maintain Viral Suppression in Adults Living With HIV-1

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Nov 14, 2018·Updated May 23, 2025

In Brief

A Phase 2 clinical trial evaluating Oral Cabotegravir (CAB), Nucleoside Reverse Transcriptase Inhibitors (NRTIs), and 3 other interventions for HIV Infections. Completed, enrolled 75 participants across 18 sites in 2 countries.

Detailed Summary

The purpose of this study was to assess the safety, tolerability, antiviral activity, and pharmacokinetics of long-acting cabotegravir (CAB LA) plus the broadly neutralizing monoclonal antibody VRC-HIVMAB075-00-AB (VRC07-523LS), in adults living with HIV-1 with suppressed plasma viremia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesPuerto Rico, United States
CollaboratorsViiV Healthcare

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 14, 2018
Enrollment StartDec 31, 2019
Primary CompletionApr 29, 2024
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 7.6 years ago

Interventions

Oral Cabotegravir (CAB)drug

30 mg tablets administered orally

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)drug

NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.

Long-Acting Injectable Cabotegravir (CAB LA)drug

600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection

VRC07-523LSbiological

40 mg/kg administered as an intravenous (IV) infusion

Standard of Care (SOC) ARTdrug

SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.