Effect of Modified, Rapid-start, DOR/3TC/TDF or DOR + FTC/TAF or BIC/FTC/TAF on Body Weight and Composition, Metabolic Risk Parameters, and Measures of Bone Strength in Treatment-Naïve Black and Hispanic Women With HIV-1 Infection
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change from Baseline of BMI after Initiation of ART Therapy at Week 48
研究概览
简要总结
The purpose of this study is determine whether different antiretroviral therapy (ART) changes the effects on body fat and predict the weight change in Black and Hispanic females.
详细描述
Study is three-arm, open-label, randomized, interventional trial, in which all patients who are successfully enrolled will be randomized 1:1:1 to initiate ART therapy with Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate vs. Doravirine + Emtricitabine/Tenofovir Alefenamide, Bictegravir/Emtricitabine/Tenofovir Alafenamide. All patients will be followed or a total o 48 weeks.
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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
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years or older;
- •No prior exposure to antiretroviral therapy for >7 days prior to study entry;
- •Plasma HIV1 RNA concentration >/=5000 copies/mL;
- •CD4 T cell count >/=200 cells/µL.
- •For persons capable of becoming pregnant, negative serum or urine pregnancy test within 45 days prior to entry
- •Ability and willingness of participant or legal guardian/representative to provide informed consent
排除标准
- •Evidence of resistance to DOR, TDF, 3TC/FTC or BIC.
- •Creatinine clearance <60 mL/min
- •Use of weight loss agents or plans to initiate weight loss program (diet or exercise-based)
- •Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation
研究组 & 干预措施
Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate
Participants to receive DOR + FTC/TAF tablets once daily for 48 weeks
干预措施: DOR + FTC/TAF (Combination Product)
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Participants to receive DOR/3TC/TDF tablet once daily for 48 weeks
干预措施: DOR/3TC/TDF (Drug)
Bictegravir/Emtricitibine/Tenofovir alafenamide
Participants to receive BIC/FTC/TAF tablet once daily for 48 weeks
干预措施: BIC/FTC/TAF (Drug)
结局指标
主要结局
Change from Baseline of BMI after Initiation of ART Therapy at Week 48
时间窗: Week 48
Comparison of weight and height is collected prior to, and during ART to determine baseline and changes of BMI (kg/m2) on ART.
Change of BMI Category after Initiation of ART Therapy at Week 48
时间窗: Week 48
Comparison of participants w/ \>10% weight change in the study arms. BMI categories: underweight (\<18.5) or normal weight (18.5 - 25) or overweight (25 - 30) or obese (\>30); or from overweight to obese.
Change in Regional Lean and Body Mass
时间窗: Week 48
Whole body Dual-energy X-ray absorptiometry (DEXA) scan (Hologic, QDR 4500A) will measure changes between study arms.
次要结局
未报告次要终点