Actively Recruiting
A Double-Blind, Randomized, Placebo-Controlled Trial of Combination HIV-Specific Broadly Neutralizing Antibodies With ART During Acute HIV Infection to Induce HIV Remission
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-21
48
Participants Needed
36
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether combining HIV-specific broadly neutralizing antibodies (bNAbs) with antiretroviral therapy (ART) in adults newly diagnosed with acute HIV infection (AHI) is safe and can delay viral rebound compared to ART alone. This phase II, randomized, double-blind, placebo-controlled study aims to assess the impact of this combination on viral load, immune response, and viral reservoirs. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). Participants are randomly assigned to receive either a combination of two bNAbs, VRC07-523LS and PGT121.414.LS, given as intravenous infusions once at study entry alongside daily oral ART, or a placebo infusion with daily ART. The study involves several steps, including treatment initiation, analytic treatment interruption, and monitoring phases. The bNAbs are administered intravenously at specific doses over 15 to 60 minutes at enrollment. ART consists of a daily oral tablet containing bictegravir, emtricitabine, and tenofovir alafenamide. During the study, participants attend scheduled visits for safety assessments, blood tests measuring viral load and immune cells, and monitoring for side effects or adverse events. Researchers track the time to viral rebound after stopping ART, changes in immune cell counts, and drug levels in the blood. Participants who meet criteria for restarting ART will do so and continue to be monitored. The total participation includes treatment and follow-up periods, with close observation to evaluate safety and treatment effects up to 24 weeks after ART interruption.
CONDITIONS
Brief Title
A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Documented diagnosis of acute HIV infection prior to enrollment as defined by specific laboratory criteria
- Laboratory values within defined limits for neutrophils, hemoglobin, platelets, kidney and liver function
- Negative pregnancy test for persons able to become pregnant, with agreement to use effective contraception methods during study steps
- Willingness and ability to initiate ART at enrollment and participate in study visits, including during analytic treatment interruption
- Ability and willingness to use barrier methods or abstinence to prevent HIV transmission during study steps
- Completion of prior study steps to progress to subsequent steps as defined
You will not qualify if you...
- Prior receipt of immunoglobulin or humanized monoclonal antibody therapy (excluding COVID-19 related)
- History of severe allergic reaction or chronic urticaria requiring daily treatment
- Use of investigational agents or candidate HIV vaccines recently
- Active or recent non-HIV malignancy requiring systemic treatment
- Use of immunomodulatory medications within 6 months prior to study entry
- Use of ART within 60 days prior to study entry
- Active drug or alcohol dependence interfering with study adherence
- Known active Hepatitis B or C infection
- Significant medical conditions or cardiovascular disease as defined by guidelines
- Pregnant or breastfeeding
- Weight over 115 kg
- Use of prohibited medications affecting study drugs within 7 days prior to entry
- Lack of adequate venous access for infusion or blood draws
- Viral failure or use of long-acting ART after initial study step
- Failure to attend required study visits or intercurrent illness increasing risk during treatment interruption
- Unwillingness or inability to restart ART after meeting restart criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment through the end of Step 1 (several weeks)
Participants receive combination HIV-specific broadly neutralizing monoclonal antibodies and start antiretroviral therapy (ART) to treat acute HIV infection.
1 infusion visit at entry and daily ART medication
Duration - From Step 1 through Step 2 entry and during ART continuation
Participants continue ART and may receive placebo or active antibody treatment as part of the randomized trial.
Regular study visits during ART administration
Duration - Up to 24 weeks after ART interruption
Participants undergo analytic treatment interruption (ATI) to monitor HIV viral rebound and immune response after stopping ART.
Weekly visits for up to 24 weeks
Trial Site Locations
Total: 36 locations
1
31788, Alabama CRS
Birmingham, Alabama, United States, 35222
Not Yet Recruiting
2
1201, University of Southern California CRS
Los Angeles, California, United States, 90033-1079
Not Yet Recruiting
3
601, University of California, Los Angeles CARE Center CRS
Los Angeles, California, United States, 90035
Not Yet Recruiting
4
701, UCSD Antiviral Research Center CRS
San Diego, California, United States, 92103
Not Yet Recruiting
5
801, University of California, San Francisco HIV/AIDS CRS
San Francisco, California, United States, 94110
Not Yet Recruiting
6
603, Harbor University of California Los Angeles Center CRS
Torrance, California, United States, 90502
Not Yet Recruiting
7
6101, University of Colorado Hospital CRS
Aurora, Colorado, United States, 80045
Actively Recruiting
8
31791, Whitman-Walker Institute, Inc. CRS
Washington D.C., District of Columbia, United States, 20005
Not Yet Recruiting
9
5802, The Ponce de Leon Center CRS
Atlanta, Georgia, United States, 30308-2012
Actively Recruiting
10
2701, Northwestern University CRS
Chicago, Illinois, United States, 60611
Not Yet Recruiting
11
2702, Rush University CRS
Chicago, Illinois, United States, 60612
Not Yet Recruiting
12
201, Johns Hopkins University CRS
Baltimore, Maryland, United States, 21205
Not Yet Recruiting
13
101, Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
14
107, Brigham and Women's Hospital Therapeutics (BWH TCRS) CRS
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
15
2101, Washington University Therapeutics (WT) CRS
St Louis, Missouri, United States, 63110-1010
Not Yet Recruiting
16
31786, New Jersey Medical School Clinical Research Center CRS
Newark, New Jersey, United States, 07103
Not Yet Recruiting
17
7804, Weill Cornell Chelsea CRS
New York, New York, United States, 10010
Not Yet Recruiting
18
30329, Columbia Physicians & Surgeons (P&S) CRS
New York, New York, United States, 10032-3732
Not Yet Recruiting
19
7803, Weill Cornell Uptown CRS
New York, New York, United States, 10065
Not Yet Recruiting
20
31787, University of Rochester Adult HIV Therapeutic Strategies Network CRS
Rochester, New York, United States, 14642
Not Yet Recruiting
21
3201, Chapel Hill CRS
Chapel Hill, North Carolina, United States, 27599-7215
Not Yet Recruiting
22
3203, Greensboro CRS
Greensboro, North Carolina, United States, 27401
Not Yet Recruiting
23
2401, Cincinnati CRS
Cincinnati, Ohio, United States, 45267-0405
Not Yet Recruiting
24
2501, Case CRS
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
25
2301, Ohio State University CRS
Columbus, Ohio, United States, 43210-1282
Actively Recruiting
26
6201, Penn Therapeutics CRS
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
27
1001, University of Pittsburgh CRS
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
28
2951, The Miriam Hospital (TMH) CRS
Providence, Rhode Island, United States, 02904
Not Yet Recruiting
29
3652, Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, United States, 37204
Not Yet Recruiting
30
31443, Trinity Health and Wellness Center CRS
Dallas, Texas, United States, 75208
Not Yet Recruiting
31
31473, Houston AIDS Research Team CRS
Houston, Texas, United States, 77030
Actively Recruiting
32
1401, University of Washington Positive Research CRS
Seattle, Washington, United States, 98104
Actively Recruiting
33
12201, Hospital Nossa Senhora da Conceicao CRS
Porto Alegre, Brazil, 91350-200
Not Yet Recruiting
34
12101, Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, Brazil
Actively Recruiting
35
11302, San Miguel CRS
San Miguel, Lima region, Peru, 32
Not Yet Recruiting
36
11301, Barranco CRS
Lima, Peru, 4
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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