Health TrialsbyHealthPanel

Menopausal HT for Women Living With HIV (HoT)

ConditionsHIV InfectionMenopause
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transdermal estradiol gel

    Drug

    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

    Drug

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

  • Placebo for estradiol gel

    Drug

    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

    Drug

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

Treatment groups

105 Participants
are divided into 2 treatment groups
Group A: Arm A: Hormone TherapyActive comparator 2 interventions
Group B: Arm B: Hormone Therapy PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in vasomotor symptoms (VMS) frequency

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.

Time frame
From 5 weeks prior to randomization to Week 12

Secondary outcomes

1

Change in vasomotor symptom (VMS) severity

Change in self-reported mean severity of VMS from 5-week observation phase prior to randomization to the one-week period prior to week 12 visit following randomization; severity scale is ordinal: none (0), mild (1), moderate (2), severe (3).

Time frame
From 5 weeks prior to randomization to week 12
2

Change in sleep

Change in total sleep scores from randomization visit to week 12 visit as measured by the Pittsburgh Sleep Quality Index (PSQI). Total sleep score determined by summing responses from seven assessments, where each assessment is scored from 0 (best) to 3 (worst). The minimum possible total sleep score is 0 (best) and the maximum possible score is 21 (worst). Higher total scores suggest more severe sleep problems. Change in total score calculated as Week 12 minus baseline. Negative change indicates better outcomes.

Time frame
From randomization to week 12
3

Change in insomnia

Change in total insomnia scores from randomization visit to week 12 visit as measured by the Insomnia Severity Index (ISI). Total insomnia score determined by summing responses from seven assessments, each rated on a Likert 5-point scale, where 0 indicates no problems and 4 indicates severe problems. The minimum possible total insomnia score is 0 (best) and the maximum possible score is 28 (worst). Higher total scores suggest more severe insomnia problems. Change in total score calculated as Week 12 minus baseline. Negative change indicates better outcomes.

Time frame
From randomization to week 12
4

Change in quality of life

Change in total health-related quality of life score, from randomization visit to week 12 visit as measured by Menopause specific Quality of life questionnaire (MenQOL). Total health-related quality of life score is determined by averaging responses from four domain-specific scores (vasomotor \[3 items\], physical \[16 items\], psychosocial \[7 items\], sexual functioning \[3 items\], each ranging from 1 (best) to 8 (worst)). Domain-specific scores represent the average score among the items in a domain. The score for each item, ranging from 1 (best) to 8 (worst), represents the sum of the presence of the symptom (1 for no, 2 for yes) and the severity, rated on a Likert 7-point scale (0, not bothered at all to 6, extremely bothered), The minimum possible quality of life score is 1 (best) and the maximum possible score is 8 (worst). Higher scores suggest more severe quality of life problems. Change in total score calculated as Week 12 minus baseline. Negative change indicates better outcomes.

Time frame
From randomization to week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

National Institute on Aging (NIA)

Collaborator

Exeltis

Collaborator

Xiromed LLC

Collaborator

Source ClinicalTrials.gov
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