Estradiol + Biktarvy for Trans Women Living with HIV
(T-DDI Trial)
ML
Overseen byMona Loutfy, MD, MPH
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Maple Leaf Research
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial investigates whether common hormone treatments for transgender women interfere with a specific HIV medication. It focuses on transgender women with HIV who are concerned about drug interactions. The study will measure drug and hormone levels in the blood to see if they affect each other.
Research Team
ML
Mona Loutfy, MD, MPH
Principal Investigator
Maple Leaf Research
Eligibility Criteria
This trial is for trans women living with HIV who are on feminizing hormone therapy and antiretroviral therapy (ART). They must be virally suppressed, willing to adjust their medication schedules, and take a specific ART regimen (B/F/TAF) for the study duration. Participants need to be adults with no relevant ART drug resistance.Inclusion Criteria
The study is looking for transgender women who are living with HIV.
You were assigned male at birth but currently identify as a woman or person undergoing a transition to become a woman.
You need to switch the timing of your medication from night to morning for at least 28 days before starting the study.
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Treatment Details
Interventions
- Biktarvy 50/200/25 Tab (Antiretroviral Combination)
- Estradiol Tablets (Hormone Therapy)
Trial OverviewThe study investigates how common feminizing hormones used by trans women interact with the HIV treatment B/F/TAF. It compares blood levels of these drugs in trans women taking both treatments against cisgender women on HIV treatment and trans women not infected by HIV.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Investigational Population (Group 1) - Trans women living with HIVExperimental Treatment2 Interventions
Trans women living with HIV, taking:
* Biktarvy
* Oral 17(Beta)-Estradiol
Group II: Comparator Population (Group 3) - Trans Women Living without HIVActive Control1 Intervention
Trans women living without HIV, taking:
-Oral 17(Beta)-Estradiol
Group III: Comparator Population (Group 2) - Cis Women Living with HIVActive Control1 Intervention
Cis women living with HIV, taking:
-Biktarvy
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Who Is Running the Clinical Trial?
Maple Leaf Research
Lead Sponsor
Trials
5
Recruited
280+