Menopausal Hormone Therapy for Women Living With HIV (HoT)

This study is looking at how well hormone therapy helps women living with HIV who are experiencing hot flashes and night sweats (vasomotor symptoms) during menopause. Women living with HIV often have more severe hot flashes, which can affect sleep, mood, and daily life. While hormone therapy is known to help women without HIV, its effects haven't been fully studied in women with HIV. This trial will test transdermal estradiol gel and, for those with an intact uterus, micronized progesterone, against placebo (an inactive substance) for 12 weeks. The main goal is to see if these treatments reduce the frequency of hot flashes and night sweats. You can join if you are a woman with HIV, aged 40-60, in menopause, and experiencing these symptoms. The current status of this study is unclear.

Study design
This interventional study plans to enroll 105 women. Participants will receive either active hormone therapy (transdermal estradiol gel and possibly micronized progesterone) or a placebo for 12 weeks.
What's involved
You would apply a gel to your skin daily for 12 weeks and, if applicable, take a pill daily for 12 weeks. You would also need to complete a daily diary.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in symptoms up to Week 12, which is the end of the treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06856174

Menopausal HT for Women Living With HIV (HoT)

Recruiting
PHASE4Ages 40–60InterventionalTreatment
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
~105 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Transdermal estradiol gelMicronized ProgesteronePlacebo for estradiol gelPlacebo for micronized progesterone

At a glance

Recruiting sites
23 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in vasomotor symptoms (VMS) frequency
Measured over From 5 weeks prior to randomization to Week 12
HIV Infection
Menopause
23 sites across 14 states
California4
Ohio3
Massachusetts2
New York2
North Carolina2
Pennsylvania2
Alabama1
Colorado1
ACTG ClinicalTrials.gov Coordinator
Email the study team

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  • Change in vasomotor symptoms (VMS) frequencyFrom 5 weeks prior to randomization to Week 12

    Change in self-reported mean VMS frequency per day from 5-week observation phase prior to randomization to the one-week period prior to week 12 visit following.