(mo)BETTA Trial in Transwomen for Optimization of ART

Inclusion Criteria:

- Self-identified transgender woman (TW)

- HIV infection

- Undetectable HIV viral load (HIV-1 RNA <50 copies/mL) at screening and for >/=24 weeks
prior to entry.

- Current HIV treatment with FTC plus TDF or TAF and a 3rd agent.

- No changes in ART in the 12 weeks prior to screening.

- Current female hormone therapy use.

- Ability and willingness of subject to provide informed consent.

Exclusion Criteria:

- Current or planned use of prohibited medications (Phenobarbital, Phenytoin,
Carbamazepine, Oxcarbazepine, Rifampin, Rifapentine, St. John's Wort, Echinacea,
Dofetilide, Cisapride, Atazanavir)

- Change or initiation of lipid- and/or glucose-lowering therapy in the 12 weeks prior
to entry, or planned need for such therapy during the study period.

- Current use of androgen therapy.

- Intent to significantly modify diet or exercise habits, or to enroll in a weight loss
intervention during the study period.

- Anticipated need to initiate or change doses of medications with anti-inflammatory
properties within the study period.

- Screening laboratory values as follows: (ANC <500 cells/mm^3; Hemoglobin <10 gm/dL; Cr
Cl <30 mL/min (estimated by CKD-Epi equation); AST or ALT >3x ULN)

- Evidence of resistance to any component of the current ART regimen (genotypic or
phenotypic)

- Current use of bictegravir in another investigational setting

- Current use of other investigational agents that the participant could not receive
unchanged, if needed, throughout the study period (unless approved by the study team)

- Any condition that the study investigator believes would make the candidate unsuitable
for participation