A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission

PHASE2RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

August 19, 2024

Primary Completion Date

April 6, 2028

Study Completion Date

September 6, 2028

Conditions
Acute HIV Infection
Interventions
BIOLOGICAL

VRC07-523LS

10 mg/kg intravenous infusion over approximately 15 to 30 minutes once at entry

BIOLOGICAL

PGT121.414.LS

5 mg/kg intravenous infusion over approximately 30 to 60 minutes once at entry

OTHER

Placebo

Sodium Chloride for Injection USP, 0.9%

DRUG

ART

Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablet orally once daily with or without food

Trial Locations (36)

4

NOT_YET_RECRUITING

11301, Barranco CRS, Lima

32

NOT_YET_RECRUITING

11302, San Miguel CRS, San Miguel

10010

NOT_YET_RECRUITING

7804, Weill Cornell Chelsea CRS, New York

10065

NOT_YET_RECRUITING

7803, Weill Cornell Uptown CRS, New York

14642

NOT_YET_RECRUITING

31787, University of Rochester Adult HIV Therapeutic Strategies Network CRS, Rochester

15213

NOT_YET_RECRUITING

1001, University of Pittsburgh CRS, Pittsburgh

19104

NOT_YET_RECRUITING

6201, Penn Therapeutics CRS, Philadelphia

20005

NOT_YET_RECRUITING

31791, Whitman-Walker Institute, Inc. CRS, Washington D.C.

21205

NOT_YET_RECRUITING

201, Johns Hopkins University CRS, Baltimore

27401

NOT_YET_RECRUITING

3203, Greensboro CRS, Greensboro

35222

NOT_YET_RECRUITING

31788, Alabama CRS, Birmingham

37204

NOT_YET_RECRUITING

3652, Vanderbilt Therapeutics (VT) CRS, Nashville

44106

NOT_YET_RECRUITING

2501, Case CRS, Cleveland

60611

NOT_YET_RECRUITING

2701, Northwestern University CRS, Chicago

60612

NOT_YET_RECRUITING

2702, Rush University CRS, Chicago

75208

NOT_YET_RECRUITING

31443, Trinity Health and Wellness Center CRS, Dallas

77030

NOT_YET_RECRUITING

31473, Houston AIDS Research Team CRS, Houston

80045

NOT_YET_RECRUITING

6101, University of Colorado Hospital CRS, Aurora

90035

NOT_YET_RECRUITING

601, University of California, Los Angeles CARE Center CRS, Los Angeles

90502

NOT_YET_RECRUITING

603, Harbor University of California Los Angeles Center CRS, Torrance

92103

NOT_YET_RECRUITING

701, UCSD Antiviral Research Center CRS, San Diego

94110

NOT_YET_RECRUITING

801, University of California, San Francisco HIV/AIDS CRS, San Francisco

98104

RECRUITING

1401, University of Washington Positive Research CRS, Seattle

90033-1079

NOT_YET_RECRUITING

1201, University of Southern California CRS, Los Angeles

30308-2012

RECRUITING

5802, The Ponce de Leon Center CRS, Atlanta

02114

NOT_YET_RECRUITING

101, Massachusetts General Hospital CRS (MGH CRS), Boston

02115

NOT_YET_RECRUITING

107, Brigham and Women's Hospital Therapeutics (BWH TCRS) CRS, Boston

63110-1010

NOT_YET_RECRUITING

2101, Washington University Therapeutics (WT) CRS, St Louis

07103

NOT_YET_RECRUITING

31786, New Jersey Medical School Clinical Research Center CRS, Newark

10032-3732

NOT_YET_RECRUITING

30329, Columbia Physicians & Surgeons (P&S) CRS, New York

27599-7215

NOT_YET_RECRUITING

3201, Chapel Hill CRS, Chapel Hill

45267-0405

NOT_YET_RECRUITING

2401, Cincinnati CRS, Cincinnati

43210-1282

NOT_YET_RECRUITING

2301, Ohio State University CRS, Columbus

02904

NOT_YET_RECRUITING

2951, The Miriam Hospital (TMH) CRS, Providence

91350-200

NOT_YET_RECRUITING

12201, Hospital Nossa Senhora da Conceicao CRS, Porto Alegre

Unknown

RECRUITING

12101, Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS, Rio de Janeiro

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH