Back to results(mo)BETTA Trial in Transwomen for Optimization of ART ((mo)BETTA)
Primary Purpose
HIV Infections
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
B/FTC/TAF
Current ART
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Transgender women, Bictegravir
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
Sites / Locations
- Thomas Street Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Switch ART
Continue Current ART
Arm Description
Switch from current antiretroviral therapy (ART) to bictegravir + tenofovir alafenamide + emtricitabine (B/FTC/TAF) for 48 weeks
Continue current antiretroviral therapy (ART) therapy (which is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks.
Outcomes
Primary Outcome Measures
Frequency of Maintaining Undetectable HIV-1 RNA
Number of participants who maintain <50 copies/mL HIV-1 RNA for 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)
Secondary Outcome Measures
Fat Mass, Total
Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)
Fat Mass, Total
Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)
Fat Mass, Trunk
Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)
Fat Mass, Trunk
Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)
Fat Mass, Limbs
Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)
Fat Mass, Limbs
Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)
Percentage of Fat Mass (Total)
Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Percentage of Fat Mass (Total)
Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Percentage of Fat Mass (Trunk)
Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)
Percentage of Fat Mass (Trunk)
Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)
Percentage of Fat Mass (Limbs)
Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)
Percentage of Fat Mass (Limbs)
Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)
Lean Mass (Total)
lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Lean Mass (Limb)
lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)
Lean Mass (Total)
lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Lean Mass (Limb)
lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)
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.
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.
Total Cholesterol
Total cholesterol level
Total Cholesterol
Total cholesterol level
High-density Lipoprotein (HDL) Cholesterol Level
High-density Lipoprotein (HDL) Cholesterol Level
Triglycerides
Triglyceride level
Triglycerides
Triglyceride level
Low-density Lipoprotein (LDL) Cholesterol Level
Low-density Lipoprotein (LDL) Cholesterol Level
Fasting Glucose Level
Fasting Glucose level
Fasting Glucose Level
Fasting Glucose level
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).
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).
Oxidized Low-density Lipoprotein (LDL) Level
Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood
Oxidized Low-density Lipoprotein (LDL) Level
Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood
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
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
Aspartate Aminotransferase (AST) Level
Aspartate Aminotransferase (AST) Level
Alanine Transaminase (ALT) Level
Alanine Transaminase (ALT) Level
Estimated Glomerular Filtration Rate (CKD- Epi Equations)
glomerular filtration rate (GFR) level
Estimated Glomerular Filtration Rate (CKD- Epi Equations)
glomerular filtration rate (GFR) level
Level of Adiponectin
Inflammatory and metabolic biomarkers level
Level of Adiponectin
Inflammatory and metabolic biomarkers level
Level of Endothelin-1
Inflammatory and metabolic biomarkers level
Level of Endothelin-1
Inflammatory and metabolic biomarkers level
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)
Inflammatory and metabolic biomarkers level
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)
Inflammatory and metabolic biomarkers level
Level of Tumor Necrosis Factor Receptor I (TNFRI)
Inflammatory and metabolic biomarkers level
Level of Tumor Necrosis Factor Receptor I (TNFRI)
Inflammatory and metabolic biomarkers level
Level of Tumor Necrosis Factor Receptor II (TNFRII)
Inflammatory and metabolic biomarkers level
Level of Tumor Necrosis Factor Receptor II (TNFRII)
Inflammatory and metabolic biomarkers level
Level of Insulin
Inflammatory and metabolic biomarkers level
Level of Insulin
Inflammatory and metabolic biomarkers level
Level of D-dimer
Inflammatory and metabolic biomarkers level
Level of D-dimer
Inflammatory and metabolic biomarkers level
Level of Tissue Factor
Inflammatory and metabolic biomarkers level
Level of Tissue Factor
Inflammatory and metabolic biomarkers level
Level of Soluble CD14 (sCD14)
Inflammatory and metabolic biomarkers level
Level of Soluble CD14 (sCD14)
Inflammatory and metabolic biomarkers level
Level of Plasminogen Activator Inhibitor (PAI-1)
Inflammatory and metabolic biomarkers level
Level of Plasminogen Activator Inhibitor (PAI-1)
Inflammatory and metabolic biomarkers level
Bone Mineral Density (BMD), Femur Total Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Bone Mineral Density (BMD), Femur Total Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Bone Mineral Density (BMD), AP-spine L1-L4
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Bone Mineral Density (BMD), AP-spine L1-L4
BMD as measured by dual-energy x-ray absorptiometry (DXA)
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
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
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
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
Bone Mineral Density (BMD), Total Body
BMD as measured by dual-energy x-ray absorptiometry (DXA)
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
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
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
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
Bone Mineral Density (BMD), Femur Neck Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Bone Mineral Density (BMD), Femur Neck Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Bone Mineral Density (BMD), Total Body
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Full Information
NCT ID
NCT03348163
First Posted
November 8, 2017
Last Updated
September 1, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03348163
Brief Title
(mo)BETTA Trial in Transwomen for Optimization of ART
Acronym
(mo)BETTA
Official Title
Bictegravir, Emtricitabine and Tenofovir Alafenamide in Transwomen for Optimization of ART: The (mo)BETTA Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of ability to recruit due to COVID-19 pandemic
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Gilead Sciences
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Transgender women, Bictegravir
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Switch ART
Arm Type
Experimental
Arm Description
Switch from current antiretroviral therapy (ART) to bictegravir + tenofovir alafenamide + emtricitabine (B/FTC/TAF) for 48 weeks
Arm Title
Continue Current ART
Arm Type
Active Comparator
Arm Description
Continue current antiretroviral therapy (ART) therapy (which is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
B/FTC/TAF
Intervention Description
B/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen)
Intervention Type
Drug
Intervention Name(s)
Current ART
Intervention Description
Current ART is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent.
Primary Outcome Measure Information:
Title
Frequency of Maintaining Undetectable HIV-1 RNA
Description
Number of participants who maintain <50 copies/mL HIV-1 RNA for 48 weeks
Time Frame
48 weeks
Title
Frequency of Adverse Events
Description
Number of participants who discontinue study drug due to study-drug related adverse events (AEs, includes >/= Grade 3 lab or clinical events)
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Fat Mass, Total
Description
Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
Baseline
Title
Fat Mass, Total
Description
Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
48 weeks
Title
Fat Mass, Trunk
Description
Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
Baseline
Title
Fat Mass, Trunk
Description
Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
48 weeks
Title
Fat Mass, Limbs
Description
Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
baseline
Title
Fat Mass, Limbs
Description
Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
48 weeks
Title
Percentage of Fat Mass (Total)
Description
Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
Baseline
Title
Percentage of Fat Mass (Total)
Description
Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
48 weeks
Title
Percentage of Fat Mass (Trunk)
Description
Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
Baseline
Title
Percentage of Fat Mass (Trunk)
Description
Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
48 weeks
Title
Percentage of Fat Mass (Limbs)
Description
Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
Baseline
Title
Percentage of Fat Mass (Limbs)
Description
Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
48 weeks
Title
Lean Mass (Total)
Description
lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
Baseline
Title
Lean Mass (Limb)
Description
lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
Baseline
Title
Lean Mass (Total)
Description
lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
48 weeks
Title
Lean Mass (Limb)
Description
lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
48 weeks
Title
Hepatic Fat Content
Description
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.
Time Frame
Baseline
Title
Hepatic Fat Content
Description
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.
Time Frame
48 weeks
Title
Total Cholesterol
Description
Total cholesterol level
Time Frame
Baseline
Title
Total Cholesterol
Description
Total cholesterol level
Time Frame
48 weeks
Title
High-density Lipoprotein (HDL) Cholesterol Level
Time Frame
Baseline
Title
High-density Lipoprotein (HDL) Cholesterol Level
Time Frame
48 weeks
Title
Triglycerides
Description
Triglyceride level
Time Frame
Baseline
Title
Triglycerides
Description
Triglyceride level
Time Frame
48 weeks
Title
Low-density Lipoprotein (LDL) Cholesterol Level
Time Frame
Baseline
Title
Low-density Lipoprotein (LDL) Cholesterol Level
Time Frame
48 weeks
Title
Fasting Glucose Level
Description
Fasting Glucose level
Time Frame
Baseline
Title
Fasting Glucose Level
Description
Fasting Glucose level
Time Frame
48 weeks
Title
Insulin Resistance
Description
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).
Time Frame
Baseline
Title
Insulin Resistance
Description
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).
Time Frame
48 weeks
Title
Oxidized Low-density Lipoprotein (LDL) Level
Description
Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood
Time Frame
Baseline
Title
Oxidized Low-density Lipoprotein (LDL) Level
Description
Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood
Time Frame
48 weeks
Title
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement
Description
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
Time Frame
Baseline
Title
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement
Description
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
Time Frame
48 weeks
Title
Aspartate Aminotransferase (AST) Level
Time Frame
Baseline
Title
Aspartate Aminotransferase (AST) Level
Time Frame
48 weeks
Title
Alanine Transaminase (ALT) Level
Time Frame
Baseline
Title
Alanine Transaminase (ALT) Level
Time Frame
48 weeks
Title
Estimated Glomerular Filtration Rate (CKD- Epi Equations)
Description
glomerular filtration rate (GFR) level
Time Frame
Baseline
Title
Estimated Glomerular Filtration Rate (CKD- Epi Equations)
Description
glomerular filtration rate (GFR) level
Time Frame
48 weeks
Title
Level of Adiponectin
Description
Inflammatory and metabolic biomarkers level
Time Frame
Baseline
Title
Level of Adiponectin
Description
Inflammatory and metabolic biomarkers level
Time Frame
48 weeks
Title
Level of Endothelin-1
Description
Inflammatory and metabolic biomarkers level
Time Frame
Baseline
Title
Level of Endothelin-1
Description
Inflammatory and metabolic biomarkers level
Time Frame
48 weeks
Title
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)
Description
Inflammatory and metabolic biomarkers level
Time Frame
Baseline
Title
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)
Description
Inflammatory and metabolic biomarkers level
Time Frame
48 weeks
Title
Level of Tumor Necrosis Factor Receptor I (TNFRI)
Description
Inflammatory and metabolic biomarkers level
Time Frame
Baseline
Title
Level of Tumor Necrosis Factor Receptor I (TNFRI)
Description
Inflammatory and metabolic biomarkers level
Time Frame
48 weeks
Title
Level of Tumor Necrosis Factor Receptor II (TNFRII)
Description
Inflammatory and metabolic biomarkers level
Time Frame
Baseline
Title
Level of Tumor Necrosis Factor Receptor II (TNFRII)
Description
Inflammatory and metabolic biomarkers level
Time Frame
48 weeks
Title
Level of Insulin
Description
Inflammatory and metabolic biomarkers level
Time Frame
Baseline
Title
Level of Insulin
Description
Inflammatory and metabolic biomarkers level
Time Frame
48 weeks
Title
Level of D-dimer
Description
Inflammatory and metabolic biomarkers level
Time Frame
Baseline
Title
Level of D-dimer
Description
Inflammatory and metabolic biomarkers level
Time Frame
48 weeks
Title
Level of Tissue Factor
Description
Inflammatory and metabolic biomarkers level
Time Frame
Baseline
Title
Level of Tissue Factor
Description
Inflammatory and metabolic biomarkers level
Time Frame
48 weeks
Title
Level of Soluble CD14 (sCD14)
Description
Inflammatory and metabolic biomarkers level
Time Frame
Baseline
Title
Level of Soluble CD14 (sCD14)
Description
Inflammatory and metabolic biomarkers level
Time Frame
48 weeks
Title
Level of Plasminogen Activator Inhibitor (PAI-1)
Description
Inflammatory and metabolic biomarkers level
Time Frame
Baseline
Title
Level of Plasminogen Activator Inhibitor (PAI-1)
Description
Inflammatory and metabolic biomarkers level
Time Frame
48 weeks
Title
Bone Mineral Density (BMD), Femur Total Mean
Description
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time Frame
Baseline
Title
Bone Mineral Density (BMD), Femur Total Mean
Description
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time Frame
48 weeks
Title
Bone Mineral Density (BMD), AP-spine L1-L4
Description
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time Frame
Baseline
Title
Bone Mineral Density (BMD), AP-spine L1-L4
Description
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time Frame
48 weeks
Title
T-Score AP-spine L1-L4
Description
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
Time Frame
Baseline
Title
T-Score AP-spine L1-L4
Description
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
Time Frame
48 weeks
Title
T-Score Total Body
Description
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
Time Frame
Baseline
Title
T-Score Total Body
Description
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
Time Frame
48 weeks
Title
Bone Mineral Density (BMD), Total Body
Description
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time Frame
Baseline
Title
T-Score Femur Total Mean
Description
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
Time Frame
Baseline
Title
T-Score Femur Total Mean
Description
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
Time Frame
48 weeks
Title
T-Score Femur Neck Mean
Description
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
Time Frame
Baseline
Title
T-Score Femur Neck Mean
Description
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
Time Frame
48 weeks
Title
Bone Mineral Density (BMD), Femur Neck Mean
Description
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time Frame
48 weeks
Title
Bone Mineral Density (BMD), Femur Neck Mean
Description
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time Frame
Baseline
Title
Bone Mineral Density (BMD), Total Body
Description
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time Frame
48 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Self-identified transgender women (TW)
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan E Lake, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Street Health Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
12. IPD Sharing Statement
Learn more about this trial
(mo)BETTA Trial in Transwomen for Optimization of ART
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