ACTG Launches HIV Cure Study Evaluating Dasatinib to Target the HIV Reservoir
Key Insights
ACTG (search) has opened A5413, a randomized, double-blind, placebo-controlled trial evaluating oral dasatinib's safety and impact on the HIV (search) reservoir in people living with HIV on suppressive ART.
The study will enroll 14 participants who have been on ART for at least four years and virally suppressed for at least three years, randomized to 100 mg daily dasatinib or placebo for 12 weeks with 24 weeks of follow-up.
This trial expands ACTG (search)'s commitment to HIV (search) cure research by targeting the persistent HIV reservoir that remains despite effective antiretroviral therapy.
CHAPEL HILL, N.C. — ACTG (search), the world's largest and longest-running clinical trials network focused on HIV (search) and other infectious diseases, has announced the opening of A5413, a study that expands the network's commitment to finding a cure for HIV by investigating the HIV reservoir in people living with HIV who are on antiretroviral therapy (ART).
A5413 is a randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and impact on the HIV (search) reservoir of oral dasatinib among people living with HIV whose viral load is controlled by taking ART. The study represents a novel approach to targeting the persistent viral reservoir that remains the primary barrier to achieving an HIV cure.
Study Design and Patient Population
The trial will enroll 14 participants aged 18 years and above who have been taking ART continuously for at least four years and have been virally suppressed for at least three years. Participants will be randomized to either receive 100 mg of oral dasatinib daily (eight participants) or matched placebo (six participants) for 12 weeks, followed by a 24-week follow-up period.
The double-blind, placebo-controlled design ensures rigorous evaluation of dasatinib's effects on the HIV (search) reservoir while controlling for potential confounding factors. The relatively small sample size is consistent with early-phase exploratory studies investigating novel mechanisms in HIV cure research.
Targeting the HIV (search) Reservoir
Despite effective ART achieving durable viral suppression, HIV (search) persists in latent reservoirs within the body, necessitating lifelong treatment. These reservoirs, composed of cells harboring replication-competent virus that is not actively producing new virions, remain invisible to the immune system and unaffected by current antiretroviral drugs. A5413 aims to evaluate whether dasatinib, a tyrosine kinase inhibitor, can impact this reservoir, potentially advancing the field toward curative strategies.
The study builds upon ACTG (search)'s extensive experience in HIV (search) research. Founded in 1987, ACTG comprises thousands of researchers, staff, and community members conducting research at 65 locations across four continents. The network is funded by the National Institute of Allergy and Infectious Diseases (NIAID (search)) and collaborating NIH Institutes.
Broader Context in HIV (search) Cure Research
A5413 expands upon ACTG (search)'s ongoing commitment to finding a cure for HIV (search), complementing the network's work across treatment optimization, comorbidities, tuberculosis, hepatitis B, and emerging infectious diseases. By focusing on the fundamental biological challenge of viral persistence, the study addresses a critical unmet need in the HIV field: the development of interventions that can achieve sustained viral remission in the absence of ART.
The opening of A5413 underscores ACTG (search)'s role in driving forward innovative clinical research that seeks to meaningfully impact the lives of people living with HIV (search) worldwide.