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

PHASE2CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

December 31, 2019

Primary Completion Date

April 29, 2024

Study Completion Date

April 29, 2024

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.

Trial Locations (18)

10010

Weill Cornell Chelsea CRS, New York

10065

Weill Cornell Uptown CRS, New York

14642

University of Rochester Adult HIV Therapeutic Strategies Network CRS, Rochester

19104

Penn Therapeutics, CRS, Philadelphia

21205

Johns Hopkins University CRS, Baltimore

27599

Chapel Hill CRS, Chapel Hill

35294

Alabama CRS, Birmingham

43210

Ohio State University CRS, Columbus

45219

Cincinnati Clinical Research Site, Cincinnati

60611

Northwestern University CRS, Chicago

80045

University of Colorado Hospital CRS, Aurora

92103

UCSD Antiviral Research Center CRS, San Diego

94110

Ucsf Hiv/Aids Crs, San Francisco

63110-1010

Washington University Therapeutics (WT) CRS, St Louis

07103

New Jersey Medical School Clinical Research Center CRS, Newark

10032-3732

Columbia P&S CRS, New York

98104-9929

University of Washington AIDS CRS, Seattle

00935

Puerto Rico AIDS Clinical Trials Unit CRS, San Juan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ViiV Healthcare

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03739996 - Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1 | Biotech Hunter | Biotech Hunter