Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

April 29, 2028

Study Completion Date

August 1, 2029

Conditions
HIV-1-infection
Interventions
BIOLOGICAL

ChAdOx1.tHIVconsv1

Administered as 0.4 mL intramuscularly (IM) at Week 0

BIOLOGICAL

ChAdOx1.HIVconsv62

Administered as 0.3 mL IM at Week 0

BIOLOGICAL

MVA.tHIVconsv3

Administered as 0.3 mL IM at Week 4

BIOLOGICAL

MVA.tHIVconsv4

Administered as 0.5 mL IM at week 4

DRUG

Vesatolimod (VES)

VES 6 mg administered orally once every 2 weeks for two doses, then VES 8 mg once every 2 weeks for 8 doses. Dose escalation may be held or the 8 mg dose may be reduced for intolerability for weeks 6 through 24.

DRUG

GS-5423

Administered via intravenous (IV) infusion at week 7

DRUG

GS-2872

Administered via IV infusion at week 7

BIOLOGICAL

MVA.tHIVconsv4

Administered 0.5 mL IM at week 60

BIOLOGICAL

Placebo

Placebos for vaccines, VES, and bnAbs

Trial Locations (14)

10032

RECRUITING

Columbia Physicians & Surgeons CRS, New York

19104

RECRUITING

Penn Therapeutics CRS, Philadelphia

27401

NOT_YET_RECRUITING

Greensboro CRS, Greensboro

27599

RECRUITING

Chapel Hill CRS, Chapel Hill

30308

RECRUITING

Ponce de Leon Center CRS, Atlanta

43210

RECRUITING

Ohio State University CRS, Columbus

45267

NOT_YET_RECRUITING

Cincinnati CRS, Cincinnati

60611

RECRUITING

Northwestern University CRS, Chicago

63110

RECRUITING

Washington University Therapeutics CRS, St Louis

77004

RECRUITING

Houston AIDS Research Team CRS, Houston

92103

RECRUITING

University of California, San Diego AntiViral Research Center CRS, San Diego

02114

NOT_YET_RECRUITING

Massachusetts General Hospital CRS (MGH CRS), Boston

91350-180

RECRUITING

Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS, Porto Alegre

Unknown

NOT_YET_RECRUITING

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS, Rio de Janeiro

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Oxford

OTHER

collaborator

Gilead Sciences

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH