A5403: Giving Standardized Estradiol Therapy In Transgender Women to Research Interactions with HIV Therapy: the GET IT RIgHT Study

Treatment Experienced

Transgender women (TW) are the fastest-growing group of people with HIV. Historically, TW have had few opportunities to participate in research, and often experience barriers to engaging in care. More research is needed to help providers when it comes to choosing HIV medications in TW on Feminizing Hormone Therapy (FHT). This is an open-label, non-randomized trial of adult TW on three types of HIV medications who will receive estradiol for FHT for 48 weeks.

• To determine the best combination of HIV medications for transgender women living with HIV who take feminizing hormone therapy.
• To determine if viral load remains undetectable while receiving FHT for 48 weeks.
• To assess if hormone levels change based on the type of HIV medication taken.

People who:

• Are 18 years or older, living with HIV
• Identify as a transgender woman or as a female or transfeminine person with male sex assigned at birth
• Are taking bictegravir, dolutegravir, or darunavir-containing HIV medications, with a viral load of less than 400 copies
• Desire to initiate or restart FHT
• Have had no estrogen therapy within 30 days

All participants will receive oral 17-β-estradiol 2 mg once daily for 48 weeks.

Dose may change based on desired goals and hormone levels.

 

Participants will complete about seven (7) visits over the course of 1 year.

Oral 17-β-estradiol is provided by the study. HIV medications must be provided by standard of care.

Participants will complete about seven (7) visits over the course of 1 year.