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(mo)BETTA Trial in Transwomen for Optimization of ART | Clinical Trials | Clareo Health

TERMINATEDPHASE4

(mo)BETTA Trial in Transwomen for Optimization of ART

Bictegravir, Emtricitabine and Tenofovir Alafenamide in Transwomen for Optimization of ART: The (mo)BETTA Trial

NCT03348163•The University of Texas Health Science Center, Houston

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).

Eligibility

Age

18 - No limit years

Sex

MALE

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

Locations (1)

Thomas Street Health Center

Houston, Texas, United States

Key Dates

Start Date

June 6, 2018

Primary Completion Date

December 15, 2020

Completion Date

December 15, 2020

Last Updated

October 3, 2022

Enrollment

ACTUAL participants

Conditions

HIV Infections

Interventions

B/FTC/TAF

DRUG

Current ART

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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(mo)BETTA Trial in Transwomen for Optimization of ART

Inclusion Criteria

Exclusion Criteria

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