(mo)BETTA Trial in Transwomen for Optimization of ART

HIV Infections Clinical Trial

— (mo)BETTA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03348163
• Other study ID #: HSC-MS-17-0480
• Status: Terminated
• Phase: Phase 4
• Start date: June 6, 2018
• Est. completion date: December 15, 2020

Study information

• Verified date: September 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• B/FTC/TAF
B/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen)
• Current ART
Current ART is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent.

Locations

Country	Name	City	State
United States	Thomas Street Health Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Maintaining Undetectable HIV-1 RNA	Number of participants who maintain <50 copies/mL HIV-1 RNA for 48 weeks	48 weeks
Primary	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	Fat Mass, Total	Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)	Baseline
Secondary	Fat Mass, Total	Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Secondary	Fat Mass, Trunk	Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)	Baseline
Secondary	Fat Mass, Trunk	Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Secondary	Fat Mass, Limbs	Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)	baseline
Secondary	Fat Mass, Limbs	Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Secondary	Percentage of Fat Mass (Total)	Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)	Baseline
Secondary	Percentage of Fat Mass (Total)	Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Secondary	Percentage of Fat Mass (Trunk)	Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)	Baseline
Secondary	Percentage of Fat Mass (Trunk)	Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Secondary	Percentage of Fat Mass (Limbs)	Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)	Baseline
Secondary	Percentage of Fat Mass (Limbs)	Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Secondary	Lean Mass (Total)	lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)	Baseline
Secondary	Lean Mass (Limb)	lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)	Baseline
Secondary	Lean Mass (Total)	lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Secondary	Lean Mass (Limb)	lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)	48 weeks
Secondary	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
Secondary	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
Secondary	Total Cholesterol	Total cholesterol level	Baseline
Secondary	Total Cholesterol	Total cholesterol level	48 weeks
Secondary	High-density Lipoprotein (HDL) Cholesterol Level		Baseline
Secondary	High-density Lipoprotein (HDL) Cholesterol Level		48 weeks
Secondary	Triglycerides	Triglyceride level	Baseline
Secondary	Triglycerides	Triglyceride level	48 weeks
Secondary	Low-density Lipoprotein (LDL) Cholesterol Level		Baseline
Secondary	Low-density Lipoprotein (LDL) Cholesterol Level		48 weeks
Secondary	Fasting Glucose Level	Fasting Glucose level	Baseline
Secondary	Fasting Glucose Level	Fasting Glucose level	48 weeks
Secondary	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
Secondary	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
Secondary	Oxidized Low-density Lipoprotein (LDL) Level	Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood	Baseline
Secondary	Oxidized Low-density Lipoprotein (LDL) Level	Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood	48 weeks
Secondary	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
Secondary	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
Secondary	Aspartate Aminotransferase (AST) Level		Baseline
Secondary	Aspartate Aminotransferase (AST) Level		48 weeks
Secondary	Alanine Transaminase (ALT) Level		Baseline
Secondary	Alanine Transaminase (ALT) Level		48 weeks
Secondary	Estimated Glomerular Filtration Rate (CKD- Epi Equations)	glomerular filtration rate (GFR) level	Baseline
Secondary	Estimated Glomerular Filtration Rate (CKD- Epi Equations)	glomerular filtration rate (GFR) level	48 weeks
Secondary	Level of Adiponectin	Inflammatory and metabolic biomarkers level	Baseline
Secondary	Level of Adiponectin	Inflammatory and metabolic biomarkers level	48 weeks
Secondary	Level of Endothelin-1	Inflammatory and metabolic biomarkers level	Baseline
Secondary	Level of Endothelin-1	Inflammatory and metabolic biomarkers level	48 weeks
Secondary	Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)	Inflammatory and metabolic biomarkers level	Baseline
Secondary	Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)	Inflammatory and metabolic biomarkers level	48 weeks
Secondary	Level of Tumor Necrosis Factor Receptor I (TNFRI)	Inflammatory and metabolic biomarkers level	Baseline
Secondary	Level of Tumor Necrosis Factor Receptor I (TNFRI)	Inflammatory and metabolic biomarkers level	48 weeks
Secondary	Level of Tumor Necrosis Factor Receptor II (TNFRII)	Inflammatory and metabolic biomarkers level	Baseline
Secondary	Level of Tumor Necrosis Factor Receptor II (TNFRII)	Inflammatory and metabolic biomarkers level	48 weeks
Secondary	Level of Insulin	Inflammatory and metabolic biomarkers level	Baseline
Secondary	Level of Insulin	Inflammatory and metabolic biomarkers level	48 weeks
Secondary	Level of D-dimer	Inflammatory and metabolic biomarkers level	Baseline
Secondary	Level of D-dimer	Inflammatory and metabolic biomarkers level	48 weeks
Secondary	Level of Tissue Factor	Inflammatory and metabolic biomarkers level	Baseline
Secondary	Level of Tissue Factor	Inflammatory and metabolic biomarkers level	48 weeks
Secondary	Level of Soluble CD14 (sCD14)	Inflammatory and metabolic biomarkers level	Baseline
Secondary	Level of Soluble CD14 (sCD14)	Inflammatory and metabolic biomarkers level	48 weeks
Secondary	Level of Plasminogen Activator Inhibitor (PAI-1)	Inflammatory and metabolic biomarkers level	Baseline
Secondary	Level of Plasminogen Activator Inhibitor (PAI-1)	Inflammatory and metabolic biomarkers level	48 weeks
Secondary	Bone Mineral Density (BMD), Femur Total Mean	BMD as measured by dual-energy x-ray absorptiometry (DXA)	Baseline
Secondary	Bone Mineral Density (BMD), Femur Total Mean	BMD as measured by dual-energy x-ray absorptiometry (DXA)	48 weeks
Secondary	Bone Mineral Density (BMD), AP-spine L1-L4	BMD as measured by dual-energy x-ray absorptiometry (DXA)	Baseline
Secondary	Bone Mineral Density (BMD), AP-spine L1-L4	BMD as measured by dual-energy x-ray absorptiometry (DXA)	48 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Bone Mineral Density (BMD), Total Body	BMD as measured by dual-energy x-ray absorptiometry (DXA)	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Bone Mineral Density (BMD), Femur Neck Mean	BMD as measured by dual-energy x-ray absorptiometry (DXA)	48 weeks
Secondary	Bone Mineral Density (BMD), Femur Neck Mean	BMD as measured by dual-energy x-ray absorptiometry (DXA)	Baseline
Secondary	Bone Mineral Density (BMD), Total Body	BMD as measured by dual-energy x-ray absorptiometry (DXA)	48 weeks