What is this study of broadly neutralizing antibodies and ART trying to find out about acute HIV infection?

This study is evaluating whether adding combination broadly neutralizing antibodies to standard ART during acute HIV infection is safe and can delay the return of the virus. Researchers aim to understand if this approach lowers viral reservoirs and strengthens the immune response. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).

Who may be eligible for this acute HIV infection clinical trial?

Adults aged 18 to 70 with a recent diagnosis of acute HIV infection who have not yet started ART may be eligible. Participants should not be pregnant or breastfeeding and must be willing to start ART and attend study visits. Please review eligibility criteria for more details.

Is there any cost to participate in this acute HIV infection clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years - 70Years

All Genders

ID05719441

Phase II Study of Combination HIV-Specific Broadly Neutralizing Antibodies with ART in Adults with Acute HIV Infection to Promote HIV Remission

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-21

Participants Needed

Research Sites

21 weeks

Total Duration

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

Age: 18Years - 70Years

All Genders

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

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