(mo)BETTA Trial in Transwomen for Optimization of ART ((mo)BETTA)

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

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).

Study Overview

• Status: Terminated
• Conditions: HIV Infections
• Intervention / Treatment: Drug: B/FTC/TAF; Drug: Current ART

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77009
      • Thomas Street Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Switch ART; Switch from current antiretroviral therapy (ART) to bictegravir + tenofovir alafenamide + emtricitabine (B/FTC/TAF) for 48 weeks	Drug: B/FTC/TAF; B/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen)
Active Comparator: 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.	Drug: Current ART; Current ART is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Maintaining Undetectable HIV-1 RNA	Number of participants who maintain <50 copies/mL HIV-1 RNA for 48 weeks	48 weeks
Frequency of Adverse Events	Number of participants who discontinue study drug due to study-drug related adverse events (AEs, includes >/= Grade 3 lab or clinical events)	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat Mass, Total	Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)	Baseline
Fat Mass, Total	Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Fat Mass, Trunk	Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)	Baseline
Fat Mass, Trunk	Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Fat Mass, Limbs	Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)	baseline
Fat Mass, Limbs	Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Percentage of Fat Mass (Total)	Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)	Baseline
Percentage of Fat Mass (Total)	Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Percentage of Fat Mass (Trunk)	Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)	Baseline
Percentage of Fat Mass (Trunk)	Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Percentage of Fat Mass (Limbs)	Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)	Baseline
Percentage of Fat Mass (Limbs)	Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Lean Mass (Total)	lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)	Baseline
Lean Mass (Limb)	lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)	Baseline
Lean Mass (Total)	lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Lean Mass (Limb)	lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Hepatic Fat Content	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.	Baseline
Hepatic Fat Content	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.	48 weeks
Total Cholesterol	Total cholesterol level	Baseline
Total Cholesterol	Total cholesterol level	48 weeks
High-density Lipoprotein (HDL) Cholesterol Level		Baseline
High-density Lipoprotein (HDL) Cholesterol Level		48 weeks
Triglycerides	Triglyceride level	Baseline
Triglycerides	Triglyceride level	48 weeks
Low-density Lipoprotein (LDL) Cholesterol Level		Baseline
Low-density Lipoprotein (LDL) Cholesterol Level		48 weeks
Fasting Glucose Level	Fasting Glucose level	Baseline
Fasting Glucose Level	Fasting Glucose level	48 weeks
Insulin Resistance	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).	Baseline
Insulin Resistance	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).	48 weeks
Oxidized Low-density Lipoprotein (LDL) Level	Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood	Baseline
Oxidized Low-density Lipoprotein (LDL) Level	Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood	48 weeks
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement	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	Baseline
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement	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	48 weeks
Aspartate Aminotransferase (AST) Level		Baseline
Aspartate Aminotransferase (AST) Level		48 weeks
Alanine Transaminase (ALT) Level		Baseline
Alanine Transaminase (ALT) Level		48 weeks
Estimated Glomerular Filtration Rate (CKD- Epi Equations)	glomerular filtration rate (GFR) level	Baseline
Estimated Glomerular Filtration Rate (CKD- Epi Equations)	glomerular filtration rate (GFR) level	48 weeks
Level of Adiponectin	Inflammatory and metabolic biomarkers level	Baseline
Level of Adiponectin	Inflammatory and metabolic biomarkers level	48 weeks
Level of Endothelin-1	Inflammatory and metabolic biomarkers level	Baseline
Level of Endothelin-1	Inflammatory and metabolic biomarkers level	48 weeks
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)	Inflammatory and metabolic biomarkers level	Baseline
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)	Inflammatory and metabolic biomarkers level	48 weeks
Level of Tumor Necrosis Factor Receptor I (TNFRI)	Inflammatory and metabolic biomarkers level	Baseline
Level of Tumor Necrosis Factor Receptor I (TNFRI)	Inflammatory and metabolic biomarkers level	48 weeks
Level of Tumor Necrosis Factor Receptor II (TNFRII)	Inflammatory and metabolic biomarkers level	Baseline
Level of Tumor Necrosis Factor Receptor II (TNFRII)	Inflammatory and metabolic biomarkers level	48 weeks
Level of Insulin	Inflammatory and metabolic biomarkers level	Baseline
Level of Insulin	Inflammatory and metabolic biomarkers level	48 weeks
Level of D-dimer	Inflammatory and metabolic biomarkers level	Baseline
Level of D-dimer	Inflammatory and metabolic biomarkers level	48 weeks
Level of Tissue Factor	Inflammatory and metabolic biomarkers level	Baseline
Level of Tissue Factor	Inflammatory and metabolic biomarkers level	48 weeks
Level of Soluble CD14 (sCD14)	Inflammatory and metabolic biomarkers level	Baseline
Level of Soluble CD14 (sCD14)	Inflammatory and metabolic biomarkers level	48 weeks
Level of Plasminogen Activator Inhibitor (PAI-1)	Inflammatory and metabolic biomarkers level	Baseline
Level of Plasminogen Activator Inhibitor (PAI-1)	Inflammatory and metabolic biomarkers level	48 weeks
Bone Mineral Density (BMD), Femur Total Mean	BMD as measured by dual-energy x-ray absorptiometry (DXA)	Baseline
Bone Mineral Density (BMD), Femur Total Mean	BMD as measured by dual-energy x-ray absorptiometry (DXA)	48 weeks
Bone Mineral Density (BMD), AP-spine L1-L4	BMD as measured by dual-energy x-ray absorptiometry (DXA)	Baseline
Bone Mineral Density (BMD), AP-spine L1-L4	BMD as measured by dual-energy x-ray absorptiometry (DXA)	48 weeks
T-Score AP-spine L1-L4	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	Baseline
T-Score AP-spine L1-L4	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	48 weeks
T-Score Total Body	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	Baseline
T-Score Total Body	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	48 weeks
Bone Mineral Density (BMD), Total Body	BMD as measured by dual-energy x-ray absorptiometry (DXA)	Baseline
T-Score Femur Total Mean	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	Baseline
T-Score Femur Total Mean	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	48 weeks
T-Score Femur Neck Mean	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	Baseline
T-Score Femur Neck Mean	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	48 weeks
Bone Mineral Density (BMD), Femur Neck Mean	BMD as measured by dual-energy x-ray absorptiometry (DXA)	48 weeks
Bone Mineral Density (BMD), Femur Neck Mean	BMD as measured by dual-energy x-ray absorptiometry (DXA)	Baseline
Bone Mineral Density (BMD), Total Body	BMD as measured by dual-energy x-ray absorptiometry (DXA)	48 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Jordan E Lake, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2018
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Transgender women; Bictegravir
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: HSC-MS-17-0480

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No