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NCT06856174 · ClinicalTrials.gov record · last posted 2026-05-22

Menopausal HT for Women Living With HIV (HoT)

Study acronym: HoT
StatusRecruiting
PhasePhase 4
Started2026-04-09
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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

Protocol amendment history 2 changes detected by DataLookout

2026-05-23
notable
Recruitment opened
2026-05-23
minor
Trial sites expanded: 0 → 23 locations
Trial Details
NCT Number NCT06856174
Lead Sponsor Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Aging (NIA), Exeltis, Xiromed LLC
Conditions HIV Infection, Menopause
Enrollment 105 participants
Start Date 2026-04-09
Primary Completion 2027-09-20 (estimated)
Study Completion 2027-09-20 (estimated)
Updated on ClinicalTrials.gov 2026-05-22