NCT06856174 · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Menopausal HT for Women Living With HIV (HoT)
(HoT)
What this study is 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.
View original scientific description
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.
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.
Primary outcome measures
Change in vasomotor symptoms (VMS) frequency
Time frame: From 5 weeks prior to randomization to Week 12
Change in self-reported mean VMS frequency per day from 5-week observation phase prior to randomization to the one-week period prior to week 12 visit following.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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
Where
- Birmingham, Alabama
- Los Angeles, California
- San Diego, California
- San Francisco, California
- Torrance, California
- Aurora, Colorado
- Atlanta, Georgia
- Chicago, Illinois
- Baltimore, Maryland
- Boston, Massachusetts
- St Louis, Missouri
- Newark, New Jersey
And 9 more locations — see the full list below.
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Aging (NIA), Exeltis, Xiromed LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations