Study: NCT05663892

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Biktarvy 50/200/25 Tab
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Biktarvy 50/200/25 Tab
Description: 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.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Estradiol Tablets
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Estradiol Tablets
Description: 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.