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Recruiting
NCT05719441
A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
Conditions: Acute HIV Infection
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 48
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Location: 31788, Alabama CRS Birmingham Alabama
Summary
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.
Eligibility 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.
Source: ClinicalTrials.gov (NCT05719441). StuddyBuddy aggregates publicly available trial information.