Menopausal HT for Women Living With HIV (HoT)

Purpose

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

Eligibility

Eligible Ages
Between 40 Years and 60 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
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.
  • 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.

Recruiting Locations

Brigham and Women's Hosp. ACTG CRS (107)
Boston, Massachusetts 02115
Contact:
Hannah Jordan
617-732-4785
hcjordan@bwh.harvard.edu

More Details

Status
Recruiting
Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Study Contact

ACTG ClinicalTrials.gov Coordinator
301-628-3348
ACTGCT.gov@dlhcorp.com