Actively Recruiting
A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation 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
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A5388 is a phase II, two-arm, randomized, double-blind, placebo-controlled study that will enroll 48 antiretroviral therapy (ART)-naïve adults with acute HIV infection (AHI) in order to determine whether: * Administration of combination HIV-specific broadly neutralizing antibody (bNAb) therapy in addition to ART during acute HIV infection (AHI) will be safe. * Participants who receive combination bNAb therapy in addition to ART during AHI will be more likely to demonstrate a delay in time to HIV-1 RNA ≥1,000 copies/mL for 4 consecutive weeks compared to participants who receive placebo plus ART. * Participants who receive combination bNAb therapy in addition to ART during AHI will demonstrate lower viral reservoirs and enhanced HIV-specific immunity compared to participants who receive placebo plus ART.
CONDITIONS
Official 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...
- Diagnosed with acute HIV infection confirmed by specific HIV RNA and antibody tests within defined time frames prior to enrollment
- Laboratory values within 21 days prior to entry including ANC 61,000/mm3, hemoglobin >10 g/dL for cisgender men and transgender women or >9 g/dL for cisgender women and transgender men, platelet count 100,000/mm3, eGFR 650 mL/min/1.73m2, ALT and AST 62.5 x ULN, and total bilirubin <1.5 x ULN
- Negative pregnancy test within 24 hours prior to study entry for persons able to become pregnant
- Agreement to use two contraception methods if able to become pregnant and sexually active during Step 1, including one highly effective and one barrier method
- Agreement to use barrier methods or abstinence to prevent HIV transmission during Steps 2, 3, and until HIV RNA is undetectable after ART restart
- Age between 18 and 70 years
- Willingness and ability to start ART at enrollment
- Willingness and ability to participate in all scheduled study visits including during analytic treatment interruption
- Ability to provide informed consent
- For Step 2, negative hepatitis B surface antigen and hepatitis C antibody or RNA tests within 16 weeks prior to registration
- Full receipt of study infusions at enrollment
- HIV-1 RNA <200 copies/mL and CD4+ T-cell count 6450 cells/mm3 within 6 weeks prior to Step 2 registration
- Negative pregnancy test within 48 hours prior to Step 2 entry if able to become pregnant
- Agreement to use contraception or abstinence to avoid pregnancy during Step 2 and Step 3
- Completion of prior study steps as required
- Willingness to interrupt ART during Step 2
You will not qualify if you...
- Prior receipt of immunoglobulin therapy or humanized/human monoclonal antibodies (except for COVID-19 treatment)
- History of severe allergic reactions or chronic urticaria requiring daily treatment
- Use of investigational agents within 28 days prior to enrollment
- Participation in investigational HIV vaccine or immune prophylaxis studies with active or blinded product
- Recent or active non-HIV malignancy requiring systemic therapy or surgery
- Use of immunomodulatory medications within 6 months prior to entry
- Use of ART within 60 days prior to study entry
- Active drug or alcohol dependence affecting adherence
- Known active Hepatitis B or C infection
- Significant medical conditions or cardiovascular disease as defined by ACC/AHA guidelines
- Current pregnancy or breastfeeding
- Weight over 115 kg
- Use of prohibited medications affecting study drugs within 7 days prior to entry
- Inadequate venous access for infusion or blood draws
- Viral failure or failure to initiate ART as defined
- Receipt of long-acting ART or immunomodulatory treatments after Step 1 entry
- Participant in Fiebig stage VI at study entry
- Missed three consecutive Step 1 visits
- Intercurrent illness increasing risk during treatment interruption
- Unwillingness or inability to restart ART after meeting restart criteria
- Transfer to other studies as specified
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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