Status:
TERMINATED
(mo)BETTA Trial in Transwomen for Optimization of ART
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV Infections
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03348163
Start Date
June 6 2018
End Date
December 15 2020
Last Update
October 3 2022
Active Locations (1)
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1
Thomas Street Health Center
Houston, Texas, United States, 77009