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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05719441). StuddyBuddy aggregates publicly available trial information.