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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Acute HIV Infection

In brief

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.

Key facts

Study ID

NCT05719441

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

48

Starts

2024-08-19

Expected to finish

2028-09-06

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Step 1:
• Appropriate documentation from medical records of diagnosis of AHI prior to enrollment that includes one of the following:
• A detectable HIV-1 RNA within 28 days prior to study entry AND a non-reactive HIV-1 antibody within 7 days prior to entry; OR
• A detectable HIV-1 RNA or a reactive HIV-1 antibody within 28 days prior to study entry AND a negative/indeterminate Western Blot (WB) or negative/indeterminate Geenius HIV-1/HIV-2 Supplemental Assay within 7 days prior to entry; OR
• A documented non-reactive HIV-1 antibody or negative HIV-1 RNA within 90 days prior to study entry AND a documented reactive HIV-1 antibody or positive WB that is negative for p31 band or a positive Geenius HIV-1/HIV-2 Supplemental Assay that is negative for p31 band within 7 days prior to entry; OR
• ARCHITECT or GSCOMBO S/CO ≥10 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry; OR
• ARCHITECT or GSCOMBO S/CO ≥1 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry AND a known prior S/CO <0.5 within 90 days prior to entry; OR
• ARCHITECT or GSCOMBO S/CO >0.5 but <10 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry AND detectable HIV-1 RNA within 7 days prior to entry
• The following laboratory values obtained within 21 days prior to entry:
• Absolute neutrophil count (ANC) ˃1,000/mm3
• Hemoglobin:
• >10 g/dL for cisgender men and transgender women
• >9 g/dL for cisgender women and transgender men
• Platelet count ˃100,000/mm3
• Estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation, with consideration for lower rates in special circumstances.
• ALT (SGPT) ≤2.5 x ULN
• AST (SGOT) ≤2.5 x ULN
• Total bilirubin <1.5 x ULN
• For persons who are able to become pregnant, negative urine or serum pregnancy test within 24 hours prior to study entry.
• Persons who are able to become pregnant must agree to use two methods of contraception throughout Step 1 if participating in sexual activity that could lead to pregnancy. One contraceptive method must be a highly effective method and the second method of contraception must be a barrier method.
• Participants of reproductive potential who engage in sexual activity that could lead to their partner's becoming pregnant must agree to use a barrier method of contraception throughout Step 1.
• Ability and willingness to use a barrier method or abstinence from sexual intercourse with all partners who are vulnerable to HIV or whose HIV serostatus is unknown in order to prevent HIV transmission during Step 2, Step 3, and until plasma HIV-1 RNA is less than the limit of detection after ART restart in Step 4.
• Age ≥18 and ≤70 years.
• Ability and willingness to initiate ART at enrollment.
• Ability and willingness to participate in scheduled study visits, including during the ATI, per Schedule of Evaluations (SOE).

You may not qualify if…

• Step 1:
• Previous receipt of immunoglobulin (IgG) therapy.
• Previous receipt of humanized or human monoclonal antibody whether licensed or investigational (other than for the prevention and/or treatment of SARS-CoV-2/COVID-19).
• History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis in the 2 years prior to enrollment.
• History of chronic urticaria requiring daily treatment.
• Receipt of investigational study agent within 28 days prior to enrollment.
• Past participation in an investigational study of a candidate HIV vaccine or immune prophylaxis for HIV-1 infection with receipt of active product or with receipt of active product or placebo and remains blinded to what they actually received.
• Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months.
• Use of any immunomodulatory medications within 6 months of study entry including systemic corticosteroids (long-term), immunosuppressants, anti-cancer, interleukins, systemic interferons, systemic chemotherapy, or other medications that the site investigator feels could have an immune modulatory effect.
• Use of ART for any reason, including pre- or post-exposure prophylaxis, within 60 days prior to study entry.
• Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• Known history of active Hepatitis B or Hepatitis C infection.
• Any acute, chronic, or recent and clinically significant medical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements or jeopardize the safety or rights of the participant.
• History of or current clinical atherosclerotic cardiovascular disease (ASCVD) as defined by 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines, including a previous diagnosis of any of the following:
• Acute myocardial infarction
• Acute coronary syndromes
• Stable or unstable angina
• Coronary or other arterial revascularization
• Stroke
• TIA
• Peripheral arterial disease presumed to be of atherosclerotic origin
• Currently breastfeeding or pregnant.
• Weight >115 kg.
• Use of prohibited medications for bictegravir, emtricitabine, and tenofovir alafenamide (refer to protocol section 5.8) within 7 days prior to entry, or planned use of prohibited medications during the period of study participation.
• Absence of adequate venous access for the administration of infusion or for phlebotomy to assess for the primary study endpoint.

Where it is running

• 31473, Houston AIDS Research Team CRS — Houston, Texas, United States (enrolling)
• 1401, University of Washington Positive Research CRS — Seattle, Washington, United States (enrolling)
• 2301, Ohio State University CRS — Columbus, Ohio, United States (enrolling)
• 12101, Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS — Rio de Janeiro, Brazil (enrolling)
• 5802, The Ponce de Leon Center CRS — Atlanta, Georgia, United States (enrolling)
• 6101, University of Colorado Hospital CRS — Aurora, Colorado, United States (enrolling)
• 31791, Whitman-Walker Institute, Inc. CRS — Washington D.C., District of Columbia, United States
• 2701, Northwestern University CRS — Chicago, Illinois, United States
• 2702, Rush University CRS — Chicago, Illinois, United States
• 201, Johns Hopkins University CRS — Baltimore, Maryland, United States
• 101, Massachusetts General Hospital CRS (MGH CRS) — Boston, Massachusetts, United States
• 107, Brigham and Women's Hospital Therapeutics (BWH TCRS) CRS — Boston, Massachusetts, United States
• 2101, Washington University Therapeutics (WT) CRS — St Louis, Missouri, United States
• 31786, New Jersey Medical School Clinical Research Center CRS — Newark, New Jersey, United States
• 7804, Weill Cornell Chelsea CRS — New York, New York, United States
• 30329, Columbia Physicians & Surgeons (P&S) CRS — New York, New York, United States
• 7803, Weill Cornell Uptown CRS — New York, New York, United States
• 31787, University of Rochester Adult HIV Therapeutic Strategies Network CRS — Rochester, New York, United States
• 3201, Chapel Hill CRS — Chapel Hill, North Carolina, United States
• 3203, Greensboro CRS — Greensboro, North Carolina, United States
• 2401, Cincinnati CRS — Cincinnati, Ohio, United States
• 2501, Case CRS — Cleveland, Ohio, United States
• 6201, Penn Therapeutics CRS — Philadelphia, Pennsylvania, United States
• 1001, University of Pittsburgh CRS — Pittsburgh, Pennsylvania, United States
• 2951, The Miriam Hospital (TMH) CRS — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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