Summary

Eligibility
for females ages 40-60 (full criteria)
Location
at UCLA UCSD UCSF
Dates
study started
study ends around
Principal Investigator
by Kara Chew, MD, MS (ucla)Timothy Wilkin, MD, MPH (ucsd)Annie Luetkemeyer, MD (ucsf)Eric S. Daar, MD (ucla)
Headshot of Timothy Wilkin
Timothy Wilkin
Headshot of Annie Luetkemeyer
Annie Luetkemeyer

Description

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

Official Title

Menopausal Hormone Therapy for Women Living With HIV (HoT)

Keywords

HIV Infection, Menopause, HIV Infections, Progesterone, Transdermal estradiol gel, Micronized Progesterone, Hormone Therapy

Eligibility

For females ages 40-60

  • 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

Locations

  • University of California, Los Angeles CARE Center CRS (601) accepting new patients
    Los Angeles California 90035 United States
  • UCSD Antiviral Research Center CRS (701) accepting new patients
    San Diego California 92103 United States
  • 801 University of California, San Francisco HIV/AIDS CRS accepting new patients
    San Francisco California 94110 United States
  • Harbor - UCLA Med. Ctr. CRS accepting new patients
    Torrance California 90502 United States

Lead Scientists at University of California Health

  • Kara Chew, MD, MS (ucla)
    Associate Professor-in-residence, Medicine. Authored (or co-authored) 101 research publications
  • Timothy Wilkin, MD, MPH (ucsd)
    Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 129 research publications
  • Annie Luetkemeyer, MD (ucsf)
    Professor, Medicine, School of Medicine. Authored (or co-authored) 64 research publications. Research interests: HIV therapeutic strategies · COVID-19 treatment and prevention · Sexually Transmitted Infections · DoxyPEP · Viral hepatitis · Hepatitis C · Hepatitis Elimination
  • Eric S. Daar, MD (ucla)
    Professor of Clinical, Medicine. Authored (or co-authored) 252 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
ID
NCT06856174
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 105 study participants
Last Updated