Clinical trial NCT03348163: (mo)BETTA Trial in Transwomen for Optimization of ART
Official title: Bictegravir, Emtricitabine and Tenofovir Alafenamide in Transwomen for Optimization of ART: The (mo)BETTA Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV Infections
Keywords: Transgender women
Bictegravir
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2017-11-20
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Frequency of Maintaining Undetectable HIV-1 RNA
timeFrame: 48 weeks
measure: Frequency of Adverse Events
timeFrame: 48 weeks
Secondary outcomes:
measure: Fat Mass, Total
timeFrame: Baseline
measure: Fat Mass, Total
timeFrame: 48 weeks
measure: Fat Mass, Trunk
timeFrame: Baseline
measure: Fat Mass, Trunk
timeFrame: 48 weeks
measure: Fat Mass, Limbs
timeFrame: baseline
measure: Fat Mass, Limbs
timeFrame: 48 weeks
measure: Percentage of Fat Mass (Total)
timeFrame: Baseline
measure: Percentage of Fat Mass (Total)
timeFrame: 48 weeks
measure: Percentage of Fat Mass (Trunk)
timeFrame: Baseline
measure: Percentage of Fat Mass (Trunk)
timeFrame: 48 weeks
measure: Percentage of Fat Mass (Limbs)
timeFrame: Baseline
measure: Percentage of Fat Mass (Limbs)
timeFrame: 48 weeks
measure: Lean Mass (Total)
timeFrame: Baseline
measure: Lean Mass (Limb)
timeFrame: Baseline
measure: Lean Mass (Total)
timeFrame: 48 weeks
measure: Lean Mass (Limb)
timeFrame: 48 weeks
measure: Hepatic Fat Content
timeFrame: Baseline
measure: Hepatic Fat Content
timeFrame: 48 weeks
measure: Total Cholesterol
timeFrame: Baseline
measure: Total Cholesterol
timeFrame: 48 weeks
measure: High-density Lipoprotein (HDL) Cholesterol Level
timeFrame: Baseline
measure: High-density Lipoprotein (HDL) Cholesterol Level
timeFrame: 48 weeks
measure: Triglycerides
timeFrame: Baseline
measure: Triglycerides
timeFrame: 48 weeks
measure: Low-density Lipoprotein (LDL) Cholesterol Level
timeFrame: Baseline
measure: Low-density Lipoprotein (LDL) Cholesterol Level
timeFrame: 48 weeks
measure: Fasting Glucose Level
timeFrame: Baseline
measure: Fasting Glucose Level
timeFrame: 48 weeks
measure: Insulin Resistance
timeFrame: Baseline
measure: Insulin Resistance
timeFrame: 48 weeks
measure: Oxidized Low-density Lipoprotein (LDL) Level
timeFrame: Baseline
measure: Oxidized Low-density Lipoprotein (LDL) Level
timeFrame: 48 weeks
measure: Hepatic Fibrosis as Indicated by Liver Stiffness Measurement
timeFrame: Baseline
measure: Hepatic Fibrosis as Indicated by Liver Stiffness Measurement
timeFrame: 48 weeks
measure: Aspartate Aminotransferase (AST) Level
timeFrame: Baseline
measure: Aspartate Aminotransferase (AST) Level
timeFrame: 48 weeks
measure: Alanine Transaminase (ALT) Level
timeFrame: Baseline
measure: Alanine Transaminase (ALT) Level
timeFrame: 48 weeks
measure: Estimated Glomerular Filtration Rate (CKD- Epi Equations)
timeFrame: Baseline
measure: Estimated Glomerular Filtration Rate (CKD- Epi Equations)
timeFrame: 48 weeks
measure: Level of Adiponectin
timeFrame: Baseline
measure: Level of Adiponectin
timeFrame: 48 weeks
measure: Level of Endothelin-1
timeFrame: Baseline
measure: Level of Endothelin-1
timeFrame: 48 weeks
measure: Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)
timeFrame: Baseline
measure: Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)
timeFrame: 48 weeks
measure: Level of Tumor Necrosis Factor Receptor I (TNFRI)
timeFrame: Baseline
measure: Level of Tumor Necrosis Factor Receptor I (TNFRI)
timeFrame: 48 weeks
measure: Level of Tumor Necrosis Factor Receptor II (TNFRII)
timeFrame: Baseline
measure: Level of Tumor Necrosis Factor Receptor II (TNFRII)
timeFrame: 48 weeks
measure: Level of Insulin
timeFrame: Baseline
measure: Level of Insulin
timeFrame: 48 weeks
measure: Level of D-dimer
timeFrame: Baseline
measure: Level of D-dimer
timeFrame: 48 weeks
measure: Level of Tissue Factor
timeFrame: Baseline
measure: Level of Tissue Factor
timeFrame: 48 weeks
measure: Level of Soluble CD14 (sCD14)
timeFrame: Baseline
measure: Level of Soluble CD14 (sCD14)
timeFrame: 48 weeks
measure: Level of Plasminogen Activator Inhibitor (PAI-1)
timeFrame: Baseline
measure: Level of Plasminogen Activator Inhibitor (PAI-1)
timeFrame: 48 weeks
measure: Bone Mineral Density (BMD), Femur Total Mean
timeFrame: Baseline
measure: Bone Mineral Density (BMD), Femur Total Mean
timeFrame: 48 weeks
measure: Bone Mineral Density (BMD), AP-spine L1-L4
timeFrame: Baseline
measure: Bone Mineral Density (BMD), AP-spine L1-L4
timeFrame: 48 weeks
measure: T-Score AP-spine L1-L4
timeFrame: Baseline
measure: T-Score AP-spine L1-L4
timeFrame: 48 weeks
measure: T-Score Total Body
timeFrame: Baseline
measure: T-Score Total Body
timeFrame: 48 weeks
measure: Bone Mineral Density (BMD), Total Body
timeFrame: Baseline
measure: T-Score Femur Total Mean
timeFrame: Baseline
measure: T-Score Femur Total Mean
timeFrame: 48 weeks
measure: T-Score Femur Neck Mean
timeFrame: Baseline
measure: T-Score Femur Neck Mean
timeFrame: 48 weeks
measure: Bone Mineral Density (BMD), Femur Neck Mean
timeFrame: 48 weeks
measure: Bone Mineral Density (BMD), Femur Neck Mean
timeFrame: Baseline
measure: Bone Mineral Density (BMD), Total Body
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Thomas Street Health Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jordan E Lake, MD
role: PRINCIPAL_INVESTIGATOR
References: