Recruiting

Hormone Therapy

Sponsor:

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Code:

NCT06856174

Conditions

HIV Infection

Menopause

Eligibility Criteria

Sex: Female

Age: 40 - 60

Healthy Volunteers: Not accepted

Interventions

Transdermal estradiol gel

Micronized Progesterone

Placebo for estradiol gel

Placebo for micronized progesterone

Study Details

Brief 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

Study ID

NCT06856174

Start date

Apr 9, 2026

Status verified date

May, 2026

Completion date

Sep 20, 2027

Anticipated

Primary completion date

Sep 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 60

Healthy Volunteers: Not accepted

  • 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

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Micronized Progesterone

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

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.

Placebo for micronized progesterone

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

Primary outcome measure

  • Change in vasomotor symptoms (VMS) frequency [ Time Frame: From 5 weeks prior to randomization to Week 12 ]

Central Contacts and Locations

Central contacts

ACTG ClinicalTrials.gov Coordinator

301-628-3348ACTGCT.gov@dlhcorp.com

Locations

31788 Alabama CRS

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Heather Logan

heatherlogan@uabmc.edu

Principal Investigator:

Sonya Heath, MD

University of California, Los Angeles CARE Center CRS (601)

Recruiting

Los Angeles, California, United States, 90035

Contacts

Aleen Khodabakhshian, MD

310-557-3798akhodabakhshian@mednet.ucla.edu

Principal Investigator:

Kara Chew, MD, MS

UCSD Antiviral Research Center CRS (701)

Recruiting

San Diego, California, United States, 92103

Contacts

Hendrickx M. Steven, BSN

619-708-1210smhendrickx@ucsd.edu

Principal Investigator:

Timothy Wilkin, MD, MPH

801 University of California, San Francisco HIV/AIDS CRS

Recruiting

San Francisco, California, United States, 94110

Contacts

Jay Dwyer, RN

415-514-0550jdwyer@php.ucsf.edu

Principal Investigator:

Annie Luetkemeyer, MD

Harbor - UCLA Med. Ctr. CRS

Recruiting

Torrance, California, United States, 90502

Contacts

Mario Guerrero

310-222-3848mguerrero@labiomed.org

Principal Investigator:

Eric S. Daar, MD

University of Colorado Hospital CRS (6101)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Nicola Haakonsen, BS

303-724-5931nicola.haakonsen@cuanschutz.edu

Principal Investigator:

Kristine Erlandson, MD

The Ponce de Leon Center CRS (5802)

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Ericka Patrick

404-616-6313erpatri@emory.edu

Principal Investigator:

Valeria Cantos, MD

Northwestern University CRS (2701)

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Sherryl L Wolfe, BSN, RN

312-695-4997s-wolfe@northwestern.edu

Principal Investigator:

Amesika Nyaku, MD, MS

201 Johns Hopkins University CRS

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Rebecca Becker

410-614-4036rbecke22@jhmi.edu

Principal Investigator:

Charles Flexner, MD

101 Massachusetts General Hospital (MGH) CRS

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Amy Sbrolla

asbrolla@mgh.harvard.edu

Principal Investigator:

Rajesh Gandhi, MD

Brigham and Women's Hosp. ACTG CRS (107)

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Hannah Jordan

617-732-4785hcjordan@bwh.harvard.edu

Principal Investigator:

Jennifer Manne-Goehler, MD

2101 Washington University Therapeutics (WT) CRS

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Michael Klebert, RN, PhD, CANP

314-454-0058mklebert@im.wustl.edu

Principal Investigator:

Rachel Presti, MD, PhD

New Jersey Medical School Clinical Research Center CRS (31786)

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Christie Lyn Costanza, MPH, BSN, RN, CCRC

972-972-9069costancl@njms.rutgers.edu

Principal Investigator:

Shobha Swaminathan, MD

Weill Cornell Chelsea CRS (7804)

Recruiting

New York, New York, United States, 10010

Contacts

Keisha Ballentine-Cargill, DNP, MSN, BSN

212-746-7804keb4006@med.cornell.edu

Principal Investigator:

Kristin Marks, MD

Columbia Physicians and Surgeons (P&S) CRS (30329)

Recruiting

New York, New York, United States, 10032

Contacts

Anyelina Cantos

212-305-7897ac4314@cumc.columbia.edu

Principal Investigator:

Magdalena Sobieszczyk, MD, MPH

3201 Chapel Hill CRS

Recruiting

Chapel Hill, North Carolina, United States, 27516

Contacts

Erin Hoffman

erin_hoffman@med.unc.edu

Principal Investigator:

David A. Wohl, MD

3203 Greensboro CRS

Recruiting

Greensboro, North Carolina, United States, 27401

Contacts

Kelly Phillips

Kelly.phillips@conehealth.com

Principal Investigator:

Cornelius Van Dam, MD

2401 Cincinnati CRS

Recruiting

Cincinnati, Ohio, United States, 45267-0405

Contacts

Michelle Saemann

saemanmd@ucmail.uc.edu

Principal Investigator:

Carl Fichtenbaum, MD

Case CRS (2501)

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Julie Pasternak, BSN

216-844-2738pasternak.julie@clevelandactu.org

Principal Investigator:

George Yendewa, MPH, TM, FACP

Ohio State University CRS (2301)

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Lindsay Summers, MBA, MPH

(614) 293-8529lindsay.summers@osumc.edu

Principal Investigator:

Carlos Malvestutto, MD, MPH, FIDSA

6201 Penn Therapeutics CRS

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jason Kirschner

jason.kirschner@pennmedicine.upenn.edu

Principal Investigator:

Pablo Tebas, MD

Univ of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Stacey Edick, DMSc

412-383-1748edicksm2@upmc.edu

Principal Investigator:

Sharon Riddler, MD, MPH

Houston AIDS Research Team CRS (31473)

Recruiting

Houston, Texas, United States, 77030

Contacts

Maria Martinez, BS

713-500-6718maria.l.martinez@uth.tmc.edu

Principal Investigator:

Roberto Arduino, MD

More Information

Sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections on 2026-05-22.