Menopausal HT for Women Living With HIV (HoT)

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

Conditions

• HIV Infection
• Menopause

Interventions

DRUG

Transdermal estradiol gel

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.

DRUG

Micronized Progesterone

Participants with intact uterus: Encapsulated micronized progesterone 100 mg orally once daily for 12 weeks.

DRUG

Placebo for estradiol gel

All participants: Placebo for estradiol gel 0.1%, 0.75 grams applied to the skin of the upper thigh once daily for 12 weeks.

DRUG

Placebo for micronized progesterone

• Participants with intact uterus: Encapsulated placebo for micronized progesterone 100 mg orally once daily for 12 weeks.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• National Institute on Aging (NIA)

  collaborator NIH

• Exeltis

  collaborator INDUSTRY

• Xiromed LLC

  collaborator INDUSTRY

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

  lead NETWORK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-09

Primary Completion

2027-09-20

Completion

2027-09-20

FDA Drug

Yes

Countries

• United States

Study Locations