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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
B/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen)
Current ART is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent.
Thomas Street Health Center
Houston, Texas, United States
Frequency of Maintaining Undetectable HIV-1 RNA
Number of participants who maintain \<50 copies/mL HIV-1 RNA for 48 weeks
Time frame: 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)
Time frame: 48 weeks
Fat Mass, Total
Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
Fat Mass, Total
Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 48 weeks
Fat Mass, Trunk
Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
Fat Mass, Trunk
Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 48 weeks
Fat Mass, Limbs
Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: baseline
Fat Mass, Limbs
Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 48 weeks
Percentage of Fat Mass (Total)
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Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
Percentage of Fat Mass (Total)
Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 48 weeks
Percentage of Fat Mass (Trunk)
Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
Percentage of Fat Mass (Trunk)
Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 48 weeks
Percentage of Fat Mass (Limbs)
Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
Percentage of Fat Mass (Limbs)
Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 48 weeks
Lean Mass (Total)
lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
Lean Mass (Limb)
lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
Lean Mass (Total)
lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 48 weeks
Lean Mass (Limb)
lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 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.
Time frame: 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.
Time frame: 48 weeks
Total Cholesterol
Total cholesterol level
Time frame: Baseline
Total Cholesterol
Total cholesterol level
Time frame: 48 weeks
High-density Lipoprotein (HDL) Cholesterol Level
Time frame: Baseline
High-density Lipoprotein (HDL) Cholesterol Level
Time frame: 48 weeks
Triglycerides
Triglyceride level
Time frame: Baseline
Triglycerides
Triglyceride level
Time frame: 48 weeks
Low-density Lipoprotein (LDL) Cholesterol Level
Time frame: Baseline
Low-density Lipoprotein (LDL) Cholesterol Level
Time frame: 48 weeks
Fasting Glucose Level
Fasting Glucose level
Time frame: Baseline
Fasting Glucose Level
Fasting Glucose level
Time frame: 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).
Time frame: 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).
Time frame: 48 weeks
Oxidized Low-density Lipoprotein (LDL) Level
Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood
Time frame: Baseline
Oxidized Low-density Lipoprotein (LDL) Level
Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood
Time frame: 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
Time frame: 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
Time frame: 48 weeks
Aspartate Aminotransferase (AST) Level
Time frame: Baseline
Aspartate Aminotransferase (AST) Level
Time frame: 48 weeks
Alanine Transaminase (ALT) Level
Time frame: Baseline
Alanine Transaminase (ALT) Level
Time frame: 48 weeks
Estimated Glomerular Filtration Rate (CKD- Epi Equations)
glomerular filtration rate (GFR) level
Time frame: Baseline
Estimated Glomerular Filtration Rate (CKD- Epi Equations)
glomerular filtration rate (GFR) level
Time frame: 48 weeks
Level of Adiponectin
Inflammatory and metabolic biomarkers level
Time frame: Baseline
Level of Adiponectin
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Level of Endothelin-1
Inflammatory and metabolic biomarkers level
Time frame: Baseline
Level of Endothelin-1
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)
Inflammatory and metabolic biomarkers level
Time frame: Baseline
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Level of Tumor Necrosis Factor Receptor I (TNFRI)
Inflammatory and metabolic biomarkers level
Time frame: Baseline
Level of Tumor Necrosis Factor Receptor I (TNFRI)
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Level of Tumor Necrosis Factor Receptor II (TNFRII)
Inflammatory and metabolic biomarkers level
Time frame: Baseline
Level of Tumor Necrosis Factor Receptor II (TNFRII)
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Level of Insulin
Inflammatory and metabolic biomarkers level
Time frame: Baseline
Level of Insulin
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Level of D-dimer
Inflammatory and metabolic biomarkers level
Time frame: Baseline
Level of D-dimer
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Level of Tissue Factor
Inflammatory and metabolic biomarkers level
Time frame: Baseline
Level of Tissue Factor
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Level of Soluble CD14 (sCD14)
Inflammatory and metabolic biomarkers level
Time frame: Baseline
Level of Soluble CD14 (sCD14)
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Level of Plasminogen Activator Inhibitor (PAI-1)
Inflammatory and metabolic biomarkers level
Time frame: Baseline
Level of Plasminogen Activator Inhibitor (PAI-1)
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Bone Mineral Density (BMD), Femur Total Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: Baseline
Bone Mineral Density (BMD), Femur Total Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: 48 weeks
Bone Mineral Density (BMD), AP-spine L1-L4
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: Baseline
Bone Mineral Density (BMD), AP-spine L1-L4
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 48 weeks
Bone Mineral Density (BMD), Total Body
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 48 weeks
Bone Mineral Density (BMD), Femur Neck Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: 48 weeks
Bone Mineral Density (BMD), Femur Neck Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: Baseline
Bone Mineral Density (BMD), Total Body
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: 48 weeks