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Menopausal Hormone Therapy for Women Living With HIV (HoT)

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life. Hormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV. This trial is being done to see if: * There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV * Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV * Hormone therapy is safe and tolerable for women living with HIV

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Maximum Age: 60
Healthy Volunteers: f
View:

• Living with HIV

• Assigned female sex at birth

• Between the ages of 40 and 60 years

• In the late menopausal transition (perimenopause) or early postmenopause

• Experiencing hot flashes and/or night sweats

• Willing and able to complete a daily diary

• Does not have medical condition that would contraindicate hormone therapy

• Not taking medications to treat hot flashes

• Not taking medications that cannot be combined with hormone therapy

• Receiving antiretrovirals (HIV medication) for more than 1 year

• Not pregnant and willing and able to use at least non-hormonal birth control to prevent pregnancy

• Willing and able to provide informed consent after discussion with the research staff

Locations
United States
Alabama
31788 Alabama CRS
RECRUITING
Birmingham
California
University of California, Los Angeles CARE Center CRS (601)
RECRUITING
Los Angeles
UCSD Antiviral Research Center CRS (701)
RECRUITING
San Diego
801 University of California, San Francisco HIV/AIDS CRS
RECRUITING
San Francisco
Harbor - UCLA Med. Ctr. CRS
RECRUITING
Torrance
Colorado
University of Colorado Hospital CRS (6101)
RECRUITING
Aurora
Georgia
The Ponce de Leon Center CRS (5802)
RECRUITING
Atlanta
Illinois
Northwestern University CRS (2701)
RECRUITING
Chicago
Massachusetts
101 Massachusetts General Hospital (MGH) CRS
RECRUITING
Boston
Brigham and Women's Hosp. ACTG CRS (107)
RECRUITING
Boston
Maryland
201 Johns Hopkins University CRS
RECRUITING
Baltimore
Missouri
2101 Washington University Therapeutics (WT) CRS
RECRUITING
St Louis
North Carolina
3201 Chapel Hill CRS
RECRUITING
Chapel Hill
3203 Greensboro CRS
RECRUITING
Greensboro
New Jersey
New Jersey Medical School Clinical Research Center CRS (31786)
RECRUITING
Newark
New York
Columbia Physicians and Surgeons (P&S) CRS (30329)
RECRUITING
New York
Weill Cornell Chelsea CRS (7804)
RECRUITING
New York
Ohio
2401 Cincinnati CRS
RECRUITING
Cincinnati
Case CRS (2501)
RECRUITING
Cleveland
Ohio State University CRS (2301)
RECRUITING
Columbus
Pennsylvania
6201 Penn Therapeutics CRS
RECRUITING
Philadelphia
Univ of Pittsburgh
RECRUITING
Pittsburgh
Texas
Houston AIDS Research Team CRS (31473)
RECRUITING
Houston
Contact Information
Primary
ACTG ClinicalTrials.gov Coordinator
ACTGCT.gov@dlhcorp.com
301-628-3348
Time Frame
Start Date: 2026-04-09
Estimated Completion Date: 2027-09-20
Participants
Target number of participants: 105
Treatments
Active_comparator: Arm A: Hormone Therapy
PARTICIPANTS WITH INTACT UTERUS: Transdermal estradiol gel plus oral micronized progesterone daily for 12 weeks.~PARTICIPANTS WITHOUT A UTERUS: Transdermal estradiol gel daily for 12 weeks.
Placebo_comparator: Arm B: Hormone Therapy Placebo
PARTICIPANTS WITH INTACT UTERUS: Transdermal placebo gel plus oral encapsulated placebo pill daily for 12 weeks.~PARTICIPANTS WITHOUT A UTERUS: Transdermal placebo gel alone daily for 12 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Exeltis, Xiromed LLC, National Institute on Aging (NIA)
Leads: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

This content was sourced from clinicaltrials.gov