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Antiretroviral Combination
Estradiol + Biktarvy for Trans Women Living with HIV (T-DDI Trial)
Phase 4
Recruiting
Led By Mona Loutfy, MD, MPH
Research Sponsored by Maple Leaf Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1, 2 & 6
Awards & highlights
T-DDI Trial Summary
This trial will investigate the effects of feminizing hormones on antiretroviral therapy for trans women with HIV, and vice versa, to help improve ART adherence and usage.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include changes in hormone levels or interactions affecting the effectiveness of either the hormone therapy or HIV medications.
T-DDI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 1, 2 & 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 1, 2 & 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
2h PBMC and DBS TFV-DP and FTC-TP concentrations.
4 hour serum concentration (C4h) of estradiol
BIC, FTC, and TAF area under the curve (AUC) plasma concentrations.
+5 moreSecondary outcome measures
ART adherence using theMedication Adherence Self-Reported Inventory (MASRI)
Baseline estradiol C4h serum concentration and comparison to month 2
Baseline estradiol pre-dose serum concentration (Cmin) and comparison to month 2
+7 moreOther outcome measures
Basic sociodemographic variables
Clinical variables
FHT regimens
+2 moreT-DDI Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol Tablets
2019
Completed Early Phase 1
~10
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for HIV, such as the combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide, work by targeting different stages of the HIV life cycle. Bictegravir is an integrase strand transfer inhibitor (INSTI) that prevents the viral DNA from integrating into the host cell genome, which is crucial for viral replication.
Emtricitabine and Tenofovir Alafenamide are nucleoside reverse transcriptase inhibitors (NRTIs) that inhibit the reverse transcriptase enzyme, blocking the conversion of viral RNA into DNA. This multi-targeted approach is essential for effectively reducing viral load, preventing the progression to AIDS, and improving the overall health and longevity of HIV patients.
Additionally, understanding potential drug-drug interactions, such as those with feminizing hormones, is vital for optimizing treatment efficacy and safety in diverse patient populations.
Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial.Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials.Efficacy of single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide in the treatment of HIV-1.
Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial.Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials.Efficacy of single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide in the treatment of HIV-1.
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Who is running the clinical trial?
Maple Leaf ResearchLead Sponsor
3 Previous Clinical Trials
206 Total Patients Enrolled
Mona Loutfy, MD, MPHPrincipal InvestigatorMaple Leaf Research
1 Previous Clinical Trials
16 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.If you take 2mg of estradiol per day and you usually take it at night, you must switch to taking it in the morning for at least 28 days before the start of the study until the second month visit.You have HIV.You are willing to continue taking the medication B/F/TAF for the entire 6-month study.You are currently taking a combination of medications to treat HIV, and have been taking them for at least 3 months before being screened for the trial.You must be at least 18 years old.You have been taking medication to control the amount of virus in your body for at least 3 months, and the virus in your blood has been at very low levels during that time.If you take more than 2mg of oral estradiol daily, you must be willing to take it twice a day for at least 28 days before the baseline visit and until the Month 2 visit. The morning dose must be 2mg, and the remaining dose can be taken at night.
Research Study Groups:
This trial has the following groups:- Group 1: Comparator Population (Group 3) - Trans Women Living without HIV
- Group 2: Investigational Population (Group 1) - Trans women living with HIV
- Group 3: Comparator Population (Group 2) - Cis Women Living with HIV
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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