Menopausal HT for Women Living With HIV (HoT)

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Status and phase: Begins enrollment in 4 months; Phase 4

Conditions: Menopause; HIV Infection

Treatments: Drug: Transdermal estradiol gel; Drug: Micronized Progesterone; Drug: Placebo for estradiol gel; Drug: Placebo for micronized progesterone

Study type: Interventional

Funder types: NETWORK; Industry; NIH

Identifiers

NCT06856174

ACTG A5424

UM1AI068636 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 105 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 2 patient groups, including a placebo group

Arm A: Hormone Therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Micronized Progesterone

Drug: Transdermal estradiol gel

Arm B: Hormone Therapy Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo for micronized progesterone

Drug: Placebo for estradiol gel