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Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1

NCT03739996 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-05-23

Study results available
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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.

Conditions

  • HIV Infections

Interventions

DRUG

Oral Cabotegravir (CAB)

30 mg tablets administered orally

DRUG

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

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

DRUG

Long-Acting Injectable Cabotegravir (CAB LA)

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

BIOLOGICAL

VRC07-523LS

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

DRUG

Standard of Care (SOC) ART

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

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Babafemi Taiwo, MBBS · Northwestern University CRS

  • Pablo Tebas, MD · Hospital of the University of Pennsylvania CRS

  • Leah Burke, MD · Weill Cornell Chelsea CRS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2024-04-29
Completion
2024-04-29
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03739996 on ClinicalTrials.gov