Menopausal HT for Women Living With HIV (HoT)

Conditions

• HIV Infection
• Menopause

Eligibility Criteria

Sex

FEMALE

Age

40 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Transdermal estradiol gel — DRUG
  All participants: Estradiol gel 0.1%, 0.75 grams (corresponding to estradiol 0.75 mg) applied to the skin of the upper thigh once daily for 12 weeks.
• Micronized Progesterone — DRUG
  Participants with intact uterus: Encapsulated micronized progesterone 100 mg orally once daily for 12 weeks.
• Placebo for estradiol gel — DRUG
  All participants: Placebo for estradiol gel 0.1%, 0.75 grams applied to the skin of the upper thigh once daily for 12 weeks.
• Placebo for micronized progesterone — DRUG
  • Participants with intact uterus: Encapsulated placebo for micronized progesterone 100 mg orally once daily for 12 weeks.

Study Details

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

Key Dates

Start date

Apr 9, 2026

Status verified

May 2026

Primary completion

Sep 20, 2027

Completion

Sep 20, 2027

Study Design

Enrollment

105 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Change in vasomotor symptoms (VMS) frequency [ Time Frame: From 5 weeks prior to randomization to Week 12 ]

Central Contacts

• ACTG ClinicalTrials.gov Coordinator
  301-628-3348
  [email protected]

Locations (23)

Find similar trials in Birmingham, AL

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