(mo)BETTA Trial in Transwomen for Optimization of ART

Phase 4

Terminated

Conditions: HIV Infections

Interventions: Drug: B/FTC/TAF
Drug: Current ART

Registration Number: NCT03348163

Lead Sponsor: The University of Texas Health Science Center, Houston

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 26

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Switch ART	B/FTC/TAF	Switch from current antiretroviral therapy (ART) to bictegravir + tenofovir alafenamide + emtricitabine (B/FTC/TAF) for 48 weeks
Continue Current ART	Current ART	Continue current antiretroviral therapy (ART) therapy (which is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks.

Primary Outcome Measures

Name	Time	Method
Frequency of Maintaining Undetectable HIV-1 RNA	48 weeks	Number of participants who maintain \<50 copies/mL HIV-1 RNA for 48 weeks
Frequency of Adverse Events	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 Outcome Measures

Name	Time	Method
Percentage of Fat Mass (Limbs)	48 weeks	Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)
Lean Mass (Total)	48 weeks	lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Fat Mass, Total	48 weeks	Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)
Fat Mass, Trunk	48 weeks	Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)
Lean Mass (Limb)	48 weeks	lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)
High-density Lipoprotein (HDL) Cholesterol Level	48 weeks
Triglycerides	48 weeks	Triglyceride level
Insulin Resistance	48 weeks	The Homeostatic Assessment Model of Insulin Resistance (HOMA-IR) is an index used to determine if insulin resistance is present. HOMA-IR is calculated as (\[(fasting insulin in mU/L) x (glucose in mmol/L)\]/22.5). Higher HOMA-IR values indicate greater insulin resistance. The threshold HOMA-IR value that indicates insulin resistance differs among different populations, but a common clinical cutoff is 2.6 (in other words, a HOMA-IR value of 2.6 or above is commonly interpreted to indicate insulin resistance).
Fat Mass, Limbs	48 weeks	Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)
Total Cholesterol	48 weeks	Total cholesterol level
Percentage of Fat Mass (Total)	48 weeks	Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Percentage of Fat Mass (Trunk)	48 weeks	Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)
Hepatic Fat Content	48 weeks	The controlled attenuation parameter (CAP) indicates quantity of fat in the liver (that is, hepatic fat content). CAP is assessed by performing transient elastography (TE) using a FibroScan device, which uses ultrasound. The CAP score is measured in decibels per meter (dB/m). CAP score ranges from 100 dB/m to 400 dB/m, and a higher score indicates greater hepatic fat content.
Low-density Lipoprotein (LDL) Cholesterol Level	48 weeks
Fasting Glucose Level	48 weeks	Fasting Glucose level
Oxidized Low-density Lipoprotein (LDL) Level	48 weeks	Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood
Level of Tissue Factor	48 weeks	Inflammatory and metabolic biomarkers level
Level of Soluble CD14 (sCD14)	48 weeks	Inflammatory and metabolic biomarkers level
Level of Plasminogen Activator Inhibitor (PAI-1)	48 weeks	Inflammatory and metabolic biomarkers level
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement	48 weeks	Fibrosis (that is, scarring of the liver) results in liver stiffness, and liver stiffness can be measured by liver elastography using a FibroScan device, which uses ultrasound. The liver stiffness measurement ranges from 2 kPa to 75 kPa, with a higher score indicating greater liver scarring and stiffness
Aspartate Aminotransferase (AST) Level	48 weeks
Alanine Transaminase (ALT) Level	48 weeks
Estimated Glomerular Filtration Rate (CKD- Epi Equations)	48 weeks	glomerular filtration rate (GFR) level
Level of Adiponectin	48 weeks	Inflammatory and metabolic biomarkers level
Level of Endothelin-1	48 weeks	Inflammatory and metabolic biomarkers level
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)	48 weeks	Inflammatory and metabolic biomarkers level
Level of Tumor Necrosis Factor Receptor I (TNFRI)	48 weeks	Inflammatory and metabolic biomarkers level
Level of Tumor Necrosis Factor Receptor II (TNFRII)	48 weeks	Inflammatory and metabolic biomarkers level
Level of Insulin	48 weeks	Inflammatory and metabolic biomarkers level
Level of D-dimer	48 weeks	Inflammatory and metabolic biomarkers level
Bone Mineral Density (BMD), Femur Total Mean	48 weeks	BMD as measured by dual-energy x-ray absorptiometry (DXA)
Bone Mineral Density (BMD), AP-spine L1-L4	48 weeks	BMD as measured by dual-energy x-ray absorptiometry (DXA)
T-Score AP-spine L1-L4	48 weeks	Bone mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
T-Score Total Body	48 weeks	Bone mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
Bone Mineral Density (BMD), Total Body	48 weeks	BMD as measured by dual-energy x-ray absorptiometry (DXA)
T-Score Femur Total Mean	48 weeks	Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
T-Score Femur Neck Mean	48 weeks	Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
Bone Mineral Density (BMD), Femur Neck Mean	Baseline	BMD as measured by dual-energy x-ray absorptiometry (DXA)