ACTG Launches Critical Study Evaluating Hormone Therapy for Women Living with HIV in the Menopause Transition

CHAPEL HILL, N.C., April 21, 2026 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the opening of the HoT study (Menopausal Hormone Therapy for Women Living with HIV, also known as A5424), an essential new study with the potential to significantly expand the body of knowledge around menopause among women living with HIV. HoT is a phase 4, randomized, double-blind, placebo-controlled clinical trial that will evaluate the safety and efficacy of hormone therapy (estradiol gel with or without oral progesterone) compared to placebo for women living with HIV who are in the late menopausal transition or early post-menopause and experiencing moderate to severe vasomotor symptoms (commonly known as hot flashes and flushes and night sweats).

The menopausal transition begins an average of four years before women experience their final menstrual period and is characterized by irregular menstrual cycles, hot flashes, sleep disturbances, and vaginal dryness (these symptoms can last for several years post-menopause). More than 70 percent of women in the general population experience vasomotor symptoms, with Black women and Latinas experiencing them for longer than White women. Compared to the general population, research has demonstrated that women living with HIV experience more frequent and severe vasomotor symptoms, which, importantly, correlates with increased depression and anxiety, worse cognitive function and quality of life, and interference with daily life activities, including work.

“Severe vasomotor symptoms can make it challenging to adhere to antiretroviral therapy (ART) and regularly attend healthcare visits -- both of which can negatively impact viral suppression,” said ACTG Chair Joseph J. Eron, M.D., University of North Carolina. “ACTG is excited to lead this important field of research with one of the first randomized studies evaluating menopausal hormone therapy specifically in women with HIV.”

HoT is a multi-center trial that will enroll 240 participants between the ages of 40 and 60 who self-report an average of two or more vasomotor symptoms each day (the study aims for at least 50 percent of participants to be non-White or Latina). Participants must be on ART for at least one year and be virally suppressed. Eligible participants will be enrolled into Step 1 of the study, an observational phase lasting three to five weeks, in which they will record their vasomotor symptoms daily. If their symptoms qualify, participants will then enter Step 2, during which they will either receive hormone therapy or placebo for 12 weeks. Participants who have a uterus and are randomized to the hormone therapy arm will receive estradiol gel 0.1% (0.75 grams) applied to the skin of the upper thigh and oral progesterone (100 mg) once daily for 12 weeks. Participants in the hormone therapy arm who no longer have a uterus will receive the estradiol gel alone. Participants who have a uterus who are randomized to the placebo arm will receive placebos matching the estradiol gel and progesterone. Those without a uterus will receive the placebo gel alone.

“While the menopausal transition among women living with HIV has been insufficiently studied, we know that there exists a relationship with HIV and non-HIV comorbidities,” said Study Co-Chair Sara H. Bares, M.D., University of Nebraska Medical Center. “We are hopeful that the results of HoT will provide clinicians with much-needed guidance, ultimately informing and improving care for women living with HIV as they enter midlife.”

A5424 is led by Dr. Bares and Michael T. Yin, M.D., M.S., Columbia University (Co-Chairs) and Sara E. Looby, Ph.D., ANP-BC, FAAN, Massachusetts General Hospital (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 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. Exeltis and Xiromed provided industry support for A5424.

For more information about A5424, 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 to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate 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

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