(mo)BETTA Trial in Transwomen for Optimization of ART

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine the safety and tolerability of a new HIV medication, bictegravir plus emtricitabine plus tenofovir alafenamide (B/FTC/TAF, 3 HIV medications combined into one pill) in HIV-infected transgender women (TW).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: Gilead Sciences
• Treatments: Emtricitabine; Tenofovir

Criteria

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