(mo)BETTA Trial in Transwomen for Optimization of ART

NCT ID: NCT03348163

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-06
• Study Completion Date: 2020-12-15

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 pill) in HIV-infected transgender women (TW).

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Switch ART

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

Group Type: EXPERIMENTAL

B/FTC/TAF

Intervention Type: DRUG

B/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen)

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.

Group Type: ACTIVE_COMPARATOR

Current ART

Intervention Type: DRUG

Current ART is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent.

Interventions

B/FTC/TAF

B/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen)

Intervention Type: DRUG

Current ART

Current ART is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Jordan Elizabeth Lake

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jordan E Lake, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Thomas Street Health Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-17-0480

Identifier Type: -

Identifier Source: org_study_id