(mo)BETTA Trial in Transwomen for Optimization of ART

The University of Texas System (UT)

Status and phase: Terminated; Phase 4

Conditions: HIV Infections

Treatments: Drug: Current ART; Drug: B/FTC/TAF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03348163

HSC-MS-17-0480

Details and patient eligibility

About

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).

Enrollment: 26 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Switch ART

Experimental group

Description:

Switch from current antiretroviral therapy (ART) to bictegravir + tenofovir alafenamide + emtricitabine (B/FTC/TAF) for 48 weeks

Treatment:

Drug: B/FTC/TAF

Continue Current ART

Active Comparator group

Description:

Continue current antiretroviral therapy (ART) therapy (which is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks.

Treatment:

Drug: Current ART