The DART DELIVER-02 Study

PHASE1RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

February 28, 2027

Conditions
HIV (Human Immunodeficiency Virus)
Interventions
DRUG

MGD020

Administered intravenously at 300mg/kg over 60 minutes.

DRUG

MGD014

Administered intravenously at 300mg/kg over 60 minutes.

DRUG

Vorinostat

Administered orally at 400 mg every 72 hours.

OTHER

Temporary treatment interruption

Discontinuation of antiretroviral therapy (ART) through Week 8. If a participant meets protocol-defined ART restart criteria during the temporary treatment interruption (TTI), ART will be reinitiated immediately. Participants who do not meet restart criteria will remain off ART and continue weekly monitoring until Week 8, at which point ART will be resumed.

Trial Locations (3)

27514

RECRUITING

University of North Carolina, Chapel Hill

Unknown

NOT_YET_RECRUITING

Moi University Clinical Research Center, Eldoret

NOT_YET_RECRUITING

Kenya Medical Research Institute/Walter Reed Project, Kericho

All Listed Sponsors
collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

collaborator

US Military HIV Research Program

NETWORK

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

United States Department of Defense

FED

lead

University of North Carolina, Chapel Hill

OTHER

NCT07217379 - The DART DELIVER-02 Study | Biotech Hunter | Biotech Hunter