Tests antibody combination with HIV treatment in people with early HIV infection
Tests two antibodies plus standard HIV medicine in adults with acute HIV infection.
Plain-language title generated from the registry record
Registry title: A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
Key facts
- Where
- Atlanta, Aurora, Birmingham, Chicago, Columbus, Houston, Newark, Philadelphia, and Seattle, United StatesSee the 9 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT05719441, who can take part
Where in United States
- 5802, The Ponce de Leon Center CRSAtlanta, United StatesTaking people
- 6101, University of Colorado Hospital CRSAurora, United StatesTaking people
- 31788 Alabama CRSBirmingham, United StatesTaking people
- 2701, Northwestern University CRSChicago, United StatesTaking people
- 2301, Ohio State University CRSColumbus, United StatesTaking people
- 31473, Houston Advancing Research Team CRSHouston, United StatesTaking people
- 31786, New Jersey Medical School Clinical Research Center CRSNewark, United StatesNot yet recruiting
- 6201 Penn Therapeutics CRSPhiladelphia, United StatesTaking people
- 1401, University of Washington Positive Research CRSSeattle, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Institute of Allergy and Infectious Diseases (NIAID)
- Trial code
- NCT05719441
- Record updated
- 14 October 2026
- Original description
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:Read full original descriptionShow less
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
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 during an Analytical Treatment Interruption (ATI) 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.
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.