(mo)BETTA Trial in Transwomen for Optimization of ART
Purpose
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).
Condition
- HIV Infections
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Switch ART |
Switch from current antiretroviral therapy (ART) to bictegravir + tenofovir alafenamide + emtricitabine (B/FTC/TAF) for 48 weeks |
|
Active Comparator Continue Current ART |
Continue current antiretroviral therapy (ART) therapy (which is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks. |
|
More Details
- Status
- Terminated
- Sponsor
- The University of Texas Health Science Center, Houston