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Estradiol + Biktarvy for Trans Women Living with HIV (T-DDI Trial)
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.
T-DDI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.T-DDI Trial Design
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Who is running the clinical trial?
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- 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.
- 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
- 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.
- 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.
Frequently Asked Questions
Has the FDA authorized Investigational Population (Group 1) - Trans women living with HIV?
"The safety of Investigational Population (Group 1) - Trans women living with HIV was rated 3 on a scale from 1 to 3, as the drug is already approved and this trial is in Phase 4."
Are recruitment efforts still ongoing for this experiment?
"Affirmative. Clinicaltrials.gov has information which attests to this trial's active recruitment of 45 individuals from one medical centre, with the original post date being November 23rd 2022 and its most recent update occurring on December 15th 2022."
How many individuals are actively engaged in the experiment?
"Affirmative. Clinicaltrials.gov displays that the trial, which was initially uploaded on November 23rd 2022 is still enrolling patients. 45 participants must be enrolled from one medical site and this data has been recently updated on December 15th 2022."
What goals is this trial aiming to accomplish?
"The primary goal of this medical trial is to gauge the BIC, FTC, and TAF maximum plasma concentrations within two months. Secondary objectives include comparing Baseline estradiol C4h serum concentration between Groups 1 and 3 as well as gauging their proportion that satisfies a target value; similarly assessing the change in total testosterone concentrations from baseline to Month 2 among those who switched to B/F/TAF versus those who did not switch; finally measuring satisfaction with feminizing hormone therapy via FEM-SQ questionnaire scores for all participants across both groups (0-85 importance score, 18-90 satisfaction score)."
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