Drug-Drug Interaction Study in Trans Women Living With HIV

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

November 23, 2022

Primary Completion Date

November 30, 2024

Study Completion Date

January 31, 2025

Conditions
HivTransgenderism
Interventions
DRUG

Biktarvy 50/200/25 Tab

As the HIV ART, the combination of B/F/TAF, known as Biktarvy®, which is a widely available Single Tablet Regimen (STR) approved by Health Canada is the drug under investigation. Participants in groups 1 and 2 will either have to already be taking B/F/TAF or will be required to switch to it at baseline and they will self-administer B/F/TAF once daily in the morning, with or without food. Participants taking their dosage at night will be required to switch to a morning dose at the screening visit.

DRUG

Estradiol Tablets

"Oral 17(beta)-estradiol as the estrogen and an anti-androgen (pharmaceutical \[e.g., spironolactone, cyproterone, finasteride, leuprolide, bicalutamide, dutasteride\] and/or surgical \[orchiectomy\] and/or medical \[hypogonadism\]).Doses of estradiol range from 1 mg to a maximum of 6 mg per day.~Participants must take 2 mg until the Month 2 Visit. Trans women participants in both groups 1 and 3 must divide their dose to twice a day (BID) if they are taking \> 2 mg per day and take 2 mg in the morning and the rest of the dosing in the evening. Participants who are only taking 2mg of estradiol once daily at night must switch their dosing to the morning. Participants who either crush or take the oral estradiol sublingually must switch to swallowing the tablet orally from the day after the screening visit until the Month 2 visit, otherwise the estradiol concentrations will be markedly higher."

Trial Locations (1)

M5G1K2

Maple Leaf Research, Toronto

Sponsors
All Listed Sponsors
lead

Maple Leaf Research

OTHER

NCT05663892 - Drug-Drug Interaction Study in Trans Women Living With HIV | Biotech Hunter | Biotech Hunter