The AIDS Clinical Trials Group (ACTG) has begun the IPACE-HIV study (Improving Physical Ability and Cellular Senescence Elimination in HIV). IPACE-HIV aims to evaluate the safety, tolerability, and efficacy of dasatinib and quercetin, medications that can help with reversing symptoms of frailty, in people living with HIV (PLWH), as well as their impact on physical function outcomes. Frailty, like other conditions related to aging, often affects PLWH at younger ages than people without HIV. However, studies measuring the effectiveness of dasatinib and quercetin have not included people living with HIV, and treatment for frailty has often included only non-pharmacologic interventions. As Dr. Eron at UNC discussed, “ACTG is excited to undertake the first carefully controlled study evaluating senolytics as a potential intervention against frailty among people living with HIV. This approach is exciting because it focuses on altering what may be the underlying cause of age-related conditions instead of the conditions themselves.”
The IPACE-HIV study will utilize a phase 2, double-blind, randomized design and is a multi-center trial. 80 individuals aged 50 or older will be enrolled in the study. Inclusion criteria include being diagnosed with HIV 10 or more years ago, being virally suppressed, meeting at least one frailty criteria on the Fried Frailty Evaluation, and having a slower than normal speed on the four-meter walk test. Participants will be randomly assigned to either taking dasatinib and quercetin or placebos for 12 weeks, followed by 12-weeks observation to assess the effectiveness of the medications on physical function.
IPACE-HIV is led Mary Clare Masters, M.D., Montefiore Medical Center and Albert Einstein College of Medicine, and Adam Spivak, M.D., University of Utah School of Medicine (Co-Chairs) and Frank Palella, M.D., Northwestern University (Vice Chair). ACTG is led by Joseph J. Eron, M.D., University of North Carolina Chapel Hill 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 Aging (NIA) and National Institute of Allergy and Infectious Diseases (NIAID, which also funds ACTG) under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634.
Read more about IPACE-HIV here.