ACTG Evaluates Osteoporosis Treatment as Novel Approach Targeting the HIV Reservoir
Second Study in ACTG’s Small Clinical Trials Advancing HIV Remission and Cure Program
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CHAPEL HILL, N.C., Aug. 19, 2026 (GLOBE NEWSWIRE) — ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the opening of STAIR-HIV (Small Trial of Alendronate Impact on the Reservoir of HIV, also known as A5428), a randomized, double-blind, placebo-controlled clinical trial evaluating whether alendronate (a widely used treatment for osteoporosis) may be an effective latency-reversing agent among people living with HIV whose viral load is controlled by taking antiretroviral therapy (ART).
While current HIV treatment can manage HIV very well, it cannot cure it. To suppress their virus and protect their immune systems, people living with HIV must remain on ART for life. Even when their HIV is controlled by ART, people living with HIV have latent HIV reservoirs – groups of immune cells that contain HIV but do not produce new copies of the virus. When they stop taking ART, the virus in the latent cells reactivates and infects new CD4 cells, thereby increasing the amount of HIV in a person’s body.
“STAIR-HIV seeks to translate years of systematic work into what could become an important component of future cure strategies for people living with HIV,” said ACTG Chair Joseph J. Eron, M.D., University of North Carolina. “While STAIR-HIV, like all of ACTG’s HIV cure research, does not promise a stand-alone cure for HIV, it will help us understand whether modulating specific metabolic and immunologic pathways in the HIV reservoir can safely move us closer to durable remission, an important goal for the network.”
STAIR-HIV will enroll 30 participants between the ages of 18-65 who have been taking ART for at least one year but less than 10 and are virally suppressed. The goal is for women to be at least one-quarter of study participants. Those enrolled will be randomized to either receive 70 mg of oral alendronate weekly (20 participants) or matched placebo (10 participants) for 24 weeks. Participants who opt in will undergo two sigmoidoscopies (a test looking at the lower section of the colon, near the rectum and anus) – one prior to the beginning of the study and one 22-24 weeks after the study starts. The sigmoidoscopies will assess the impact of alendronate on the HIV reservoir present in gut tissue. All participants will be followed for an additional eight weeks to determine whether the effects of alendronate continue after they complete the treatment.
“This study builds on historic ACTG work, including study A5163, which assessed the effect of weekly oral alendronate on bone mass density,” said Natalia Soriano Sarabia, Ph.D., Study Co-Chair, George Washington University. “Using samples from this trial, we were able to show that alendronate reduced total HIV DNA levels. This was a very exciting finding, but because A5163 was not designed to assess these effects, we created STAIR-HIV to do so in a controlled trial with a larger sample size. By testing this treatment under rigorous clinical monitoring, we hope to generate critical data that can guide future combination approaches to an HIV cure.”
STAIR-HIV is the second study to enroll participants through ACTG’s Small Clinical Trials Advancing HIV Remission and Cure program. This pathway was developed to support small experimental trials that aim to advance efforts related to HIV remission and cure utilizing ACTG’s sites, laboratories, and other infrastructure in partnership with lab-based and translational scientists. These studies are typically small and involve one to three existing ACTG clinical research sites that have experience with these types of trials. The pathway aims to support trials that are intensive by nature and may include specialized assays or procedures, which would render them unsuitable for ACTG’s larger multi-site studies. More information about this program is available on ACTG’s website.
STAIR-HIV is led by Dr. Soriano Sarabia and Carlos Malvestutto, M.D., M.P.H., Ohio State University Medical Center (Co-Chairs) and Marc Siegel, M.D., The George Washington Medical Faculty Associates (Vice Chair). ACTG is led by Dr. Eron and Rajesh T. Gandhi, M.D., Massachusetts General Hospital and Harvard Medical School (ACTG Vice Chair). It is sponsored by the National Institutes of Health’s (NIH) National Institute of Mental Health (NIMH) and National Institute of Allergy and Infectious Diseases (NIAID, which also funds ACTG) under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634.
For more information about STAIR-HIV, please visit clinicaltrials.gov.
About ACTG
ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research and implementation science studies to improve the management of HIV and its comorbidities; develop a cure for HIV; and discover treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve.
Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH.
Media Contact:
Jenna Conley, ACTG
jenna@conleycommunications.net
