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(mo)BETTA Trial in Transwomen for Optimization of ART

NCT03348163 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-10-03

Study results available
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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

Interventions

DRUG

B/FTC/TAF

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

DRUG

Current ART

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

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Jordan E Lake, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-06
Primary Completion
2020-12-15
Completion
2020-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03348163 on ClinicalTrials.gov