Combination broadly neutralizing HIV antibodies given with ART during acute infection to try to induce remission
Official title: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
Run by National Institute of Allergy and Infectious Diseases (NIAID) · NCT05719441 · Data updated 2026-11-12
This trial will try giving two HIV-specific broadly neutralizing antibodies along with starting ART to ART-naïve adults with acute HIV infection to see if it delays viral rebound and reduces the viral reservoir.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) NIH |
| Locations | 12 sites (Birmingham, Alabama and 11 other locations) |
| Status | Recruiting |
| Started | August 19, 2024 |
| Main results expected | July 17, 2028 |
| Study ends | June 18, 2029 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT05719441 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults very recently diagnosed with acute HIV infection who are ART‑naïve and meet the study's laboratory and timing entry criteria are the intended participants.
✕Probably not a fit
People with chronic, well-established HIV infection, those already on ART, or those with viral strains resistant to the study antibodies are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase II, randomized, double-blind, placebo-controlled trial that will enroll 48 adults diagnosed during acute HIV infection who have not yet started ART. Participants are randomized to receive combination bNAb therapy (VRC07-523LS and PGT121.414.LS) plus ART or placebo plus ART, with blinded treatment assignments. The trial will monitor safety and compare time to confirmed viral rebound (HIV-1 RNA ≥1,000 copies/mL for four consecutive weeks), along with measurements of viral reservoir size and HIV-specific immune responses. Regular clinic visits and blood sampling will be used to track viral load, immune markers, and reservoir assays over follow-up.
Why it matters
Potential benefit: If successful, this approach could let some people treated during acute infection remain off ART longer or achieve periods of remission by reducing the viral reservoir and delaying viral rebound.
How similar studies have gone: Previous trials of single or dual broadly neutralizing antibodies in chronic infection have sometimes delayed viral rebound but results have been mixed, and starting combination bNAbs during acute infection is a relatively new strategy.
Who can join: the full rules
Show full inclusion / exclusion criteria
* Between 18 and 70 years of age * Body weight under 115 kg (approximately 253 pounds) * Evidence of recently acquiring HIV * Not pregnant or breastfeeding * No recent use of medications to prevent or treat HIV * Able and willing to provide informed consent to study and its procedures which include * initiating HIV medications (also called antiretroviral treatment or ART) following enrollment, * A later, monitored pause in HIV medications (also called an analytical treatment interruption, or ATI) * While pausing HIV treatment per study guidelines until resuppressed following treatment restart, agree to using barrier contraception to prevent HIV acquisition in sexual partners * Agree to use effective contraception to prevent pregnancy in oneself and sexual partners who may become pregnant.
Where it's running
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31788, Alabama CRS
Birmingham, Alabama, United States Recruiting -
6101, University of Colorado Hospital CRS
Aurora, Colorado, United States Recruiting -
5802, The Ponce de Leon Center CRS
Atlanta, Georgia, United States Recruiting -
2701, Northwestern University CRS
Chicago, Illinois, United States Recruiting -
2301, Ohio State University CRS
Columbus, Ohio, United States Recruiting -
6201, Penn Therapeutics CRS
Philadelphia, Pennsylvania, United States Recruiting
Show 6 more locations
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31473, Houston Advancing Research Team CRS
Houston, Texas, United States Recruiting -
1401, University of Washington Positive Research CRS
Seattle, Washington, United States Recruiting -
12201, Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS
Porto Alegre, Brazil Recruiting -
12101, Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, Brazil Recruiting -
11301, Barranco CRS
Lima, Peru Recruiting -
31786, New Jersey Medical School Clinical Research Center CRS
Newark, New Jersey, United States Not yet recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Combining immune-enhancing antibodies and vaccines to control HIV after early infection
This test will see if giving long-acting HIV antibodies together with therapeutic vaccines helps people who began ART during acute HIV infection control viral levels after a planned treatment interruption.
-
Cohort study on acute HIV infection and treatment outcomes
This study is testing how starting HIV treatment right after diagnosis affects the chances of long-term remission in patients and what factors might help achieve that.
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Comparing standard and intensive HIV treatment for early infection
This study is testing whether a standard HIV treatment or a stronger version works better for people who have just been diagnosed with HIV.
-
Characterizing acute HIV infection in high-risk individuals
This study is trying to learn more about people with early HIV infection by looking at their health, behavior, and immune responses to help improve future treatments and vaccines.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.