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

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

ArmDescriptionAssigned Intervention
Experimental
Switch ART
Switch from current antiretroviral therapy (ART) to bictegravir + tenofovir alafenamide + emtricitabine (B/FTC/TAF) for 48 weeks
  • Drug: B/FTC/TAF
    B/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen)
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.
  • Drug: Current ART
    Current ART is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent.

More Details

Status
Terminated
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.