NCT03348163终止4 期
Bictegravir, Emtricitabine and Tenofovir Alafenamide in Transwomen for Optimization of ART: The (mo)BETTA Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Frequency of Maintaining Undetectable HIV-1 RNA
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Switch ART
Experimental
Switch from current antiretroviral therapy (ART) to bictegravir + tenofovir alafenamide + emtricitabine (B/FTC/TAF) for 48 weeks
干预措施: B/FTC/TAF (Drug)
Continue Current ART
Active Comparator
Continue current antiretroviral therapy (ART) therapy (which is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks.
干预措施: Current ART (Drug)
结局指标
主要结局
Frequency of Maintaining Undetectable HIV-1 RNA
时间窗: 48 weeks
Number of participants who maintain \<50 copies/mL HIV-1 RNA for 48 weeks
Frequency of Adverse Events
时间窗: 48 weeks
Number of participants who discontinue study drug due to study-drug related adverse events (AEs, includes \>/= Grade 3 lab or clinical events)
次要结局
- Percentage of Fat Mass (Limbs)(48 weeks)
- Lean Mass (Total)(48 weeks)
- High-density Lipoprotein (HDL) Cholesterol Level(48 weeks)
- Triglycerides(48 weeks)
- Fat Mass, Total(48 weeks)
- Fat Mass, Trunk(48 weeks)
- Lean Mass (Limb)(48 weeks)
- Insulin Resistance(48 weeks)
- Fat Mass, Limbs(48 weeks)
- Total Cholesterol(48 weeks)
- Percentage of Fat Mass (Total)(48 weeks)
- Percentage of Fat Mass (Trunk)(48 weeks)
- Hepatic Fat Content(48 weeks)
- Low-density Lipoprotein (LDL) Cholesterol Level(48 weeks)
- Fasting Glucose Level(48 weeks)
- Oxidized Low-density Lipoprotein (LDL) Level(48 weeks)
- Hepatic Fibrosis as Indicated by Liver Stiffness Measurement(48 weeks)
- Aspartate Aminotransferase (AST) Level(48 weeks)
- Alanine Transaminase (ALT) Level(48 weeks)
- Estimated Glomerular Filtration Rate (CKD- Epi Equations)(48 weeks)
- Level of Adiponectin(48 weeks)
- Level of Endothelin-1(48 weeks)
- Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)(48 weeks)
- Level of Tumor Necrosis Factor Receptor I (TNFRI)(48 weeks)
- Level of Tumor Necrosis Factor Receptor II (TNFRII)(48 weeks)
- Level of Insulin(48 weeks)
- Level of D-dimer(48 weeks)
- Level of Tissue Factor(48 weeks)
- Level of Soluble CD14 (sCD14)(48 weeks)
- Level of Plasminogen Activator Inhibitor (PAI-1)(48 weeks)
- Bone Mineral Density (BMD), Femur Total Mean(48 weeks)
- Bone Mineral Density (BMD), AP-spine L1-L4(48 weeks)
- T-Score AP-spine L1-L4(48 weeks)
- T-Score Total Body(48 weeks)
- Bone Mineral Density (BMD), Femur Neck Mean(Baseline)
- Bone Mineral Density (BMD), Total Body(48 weeks)
- T-Score Femur Total Mean(48 weeks)
- T-Score Femur Neck Mean(48 weeks)
研究者
Jordan Elizabeth Lake
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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