Clinical Trials/NCT03348163

NCT03348163

Terminated

Phase 4

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

The University of Texas Health Science Center, Houston1 site in 1 country26 target enrollmentJune 6, 2018

ConditionsHIV Infections

InterventionsB/FTC/TAF Current ART

DrugsB/FTC/TAF Current ART

Overview

Phase: Phase 4
Intervention: B/FTC/TAF
Conditions: HIV Infections
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 26
Locations: 1
Primary Endpoint: Frequency of Maintaining Undetectable HIV-1 RNA
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

June 6, 2018

End Date

December 15, 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Jordan Elizabeth Lake

Associate Professor

The University of Texas Health Science Center, Houston

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

Arms & Interventions

Switch ART

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

Intervention: B/FTC/TAF

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.

Intervention: Current ART

Outcomes

Primary Outcomes

Frequency of Maintaining Undetectable HIV-1 RNA

Time Frame: 48 weeks

Number of participants who maintain \<50 copies/mL HIV-1 RNA for 48 weeks

Frequency of Adverse Events

Time Frame: 48 weeks

Number of participants who discontinue study drug due to study-drug related adverse events (AEs, includes \>/= Grade 3 lab or clinical events)

Secondary Outcomes

Percentage of Fat Mass (Limbs)(48 weeks)
Lean Mass (Total)(48 weeks)
High-density Lipoprotein (HDL) Cholesterol Level(48 weeks)
Triglycerides(48 weeks)
Fat Mass, Total(48 weeks)
Fat Mass, Trunk(48 weeks)
Lean Mass (Limb)(48 weeks)
Insulin Resistance(48 weeks)
Fat Mass, Limbs(48 weeks)
Total Cholesterol(48 weeks)
Percentage of Fat Mass (Total)(48 weeks)
Percentage of Fat Mass (Trunk)(48 weeks)
Hepatic Fat Content(48 weeks)
Low-density Lipoprotein (LDL) Cholesterol Level(48 weeks)
Fasting Glucose Level(48 weeks)
Oxidized Low-density Lipoprotein (LDL) Level(48 weeks)
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement(48 weeks)
Aspartate Aminotransferase (AST) Level(48 weeks)
Alanine Transaminase (ALT) Level(48 weeks)
Estimated Glomerular Filtration Rate (CKD- Epi Equations)(48 weeks)
Level of Adiponectin(48 weeks)
Level of Endothelin-1(48 weeks)
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)(48 weeks)
Level of Tumor Necrosis Factor Receptor I (TNFRI)(48 weeks)
Level of Tumor Necrosis Factor Receptor II (TNFRII)(48 weeks)
Level of Insulin(48 weeks)
Level of D-dimer(48 weeks)
Level of Tissue Factor(48 weeks)
Level of Soluble CD14 (sCD14)(48 weeks)
Level of Plasminogen Activator Inhibitor (PAI-1)(48 weeks)
Bone Mineral Density (BMD), Femur Total Mean(48 weeks)
Bone Mineral Density (BMD), AP-spine L1-L4(48 weeks)
T-Score AP-spine L1-L4(48 weeks)
T-Score Total Body(48 weeks)
Bone Mineral Density (BMD), Femur Neck Mean(Baseline)
Bone Mineral Density (BMD), Total Body(48 weeks)
T-Score Femur Total Mean(48 weeks)
T-Score Femur Neck Mean(48 weeks)