Safety, Tolerability, and Efficacy of a Dose Reduction Strategy Based on Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-infected Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Viral efficacy of the reduction of BETAF regimen dose per week at 12 weeks.
研究概览
简要总结
This is a phase IV, unicentric, open, pilot, randomized, controlled trial to evaluate Bictegravir/FTC/TAF. The study will be developed at a single clinical care centre:Hospital Clínic de Barcelona, Barcelona, Spain. The aim of this study is to assess the feasibility of dose redutions of Bictegravir/FTC/TAF in virologically suppressed HIV-infected adults on BETAF once daily. The reduction of drug exposure will have a significant positive impact on parameters reflecting potential toxicities associated with bictegravir or tenofovir.
详细描述
The Primary objectives are:
- To assess viral efficacy of the reductions of BETAF regimen dose at 12 weeks (on-treatment and intent-to-treat populations).
- To asess viral efficacy of the reduction of BETAF regimen dose at 48 weeks (on-treatment and intent-to-treat populations).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Stable and asymptomatic HIV-infected adults (≥18 years) on BETAF once daily for at least the previous 6 months.
- •Plasma HIV-1 RNA less than 50 copies/mL for at least the previous 6 months.
- •CD4 cell counts greater than 350 cells/mL at the time of consideration for the study.
- •Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods.
- •Patients agreed to participate.
排除标准
- •Prior virological failure to any antiretroviral regimen or documented.
- •Any diagnosis of psychiatric illness.
- •Alcohol abuse or illicit drug consumption (based on their past medical history and specific questions at the time of recruitment).
- •Patients co-infected with HIV and active hepatitis B or C virus.
- •Any other condition at the doctor's discretion that did not allow ensuring a correct adherence.
研究组 & 干预措施
BETAF OD arm
one tablet taken orally once daily
干预措施: Biktarvy 50 mg/200 mg/25 mg film-coated tablets (Drug)
BETAF 3W arm
one tablet taken orally 3 days per week : Mondays, Wednesdays, and Fridays
干预措施: Biktarvy 50 mg/200 mg/25 mg film-coated tablets (Drug)
BETAF 2W arm
one tablet taken orally 2 days per week : Mondays, and Thursdays
干预措施: Biktarvy 50 mg/200 mg/25 mg film-coated tablets (Drug)
BETAF 1W arm
one tablet taken orally 1 days per week : Mondays
干预措施: Biktarvy 50 mg/200 mg/25 mg film-coated tablets (Drug)
结局指标
主要结局
Viral efficacy of the reduction of BETAF regimen dose per week at 12 weeks.
时间窗: at 12 weeks
standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL
Viral efficacy of the reduction of BETAF regimen dose per week at 48 weeks.
时间窗: at 48 weeks.
standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL
次要结局
- Impact on sleep quality assessed by Pittsburg Sleep Quality(at 0 and 48 weeks)
- Immunological safety assessed by CD4 and CD8 cells(at 0, 12 and 48 weeks)
- Minimum plasma concentration of bictegravir, emtricitabine and tenofovir (Cmim) assessed by Plasma levels of bictegravir, emtricitabine and tenofovir(at 0, 12, and 48 weeks)
- Virological efficacy assessed by Standard plasma viral load(at 4, 24, and 36 weeks.)
- Virological efficacy assessed by Blips (VL ≥50 copies/mL followed)(at 0, 4, 12, 24, 36, and 48 weeks)
- Virological efficacy assessed by HIV-1 reservoir (total and integrated DNA (copies/106 PBMC)) in CD4 cells(at 0, 12, and 48 weeks.)
- Immunological safety 2 assessed by hsCRP, IL-6 and adiponectin levels(at 0, 12 and 48 weeks)
- Quality of life questionnaire assessed by EuroQol Group EQ-5D™ questionnaire(at 0 and 4,12,24,36, 48 weeks)
- Virological efficacy assessed by Target not detected with standard plasma viral load (VL ≥ HIV RNA 50 copies/mL)(at 0, 4, 12, 24, 36, and 48 weeks)
- Virological efficacy assessed by Ultrasensitive plasma viral load (lower limit of detection 5 copies/mL)(at 0, 12, and 48 weeks.)
- Virological efficacy assessed by ultra-deep sequencing of plasma and intracellular viral load to detect genotypic resistance(at 0, 4, 12, 24, 36 and 48 weeks)
- Immunological safety assessed by sCD14 and CD163 as a Immune activation markers(at 0, 12 and 48 weeks)
- Subclinical toxicity assessed by BMI index(at 4, 12, 24, 36, and 48)
- Body composition assessed by DEXA scan(at 0 and 48 weeks)
- Minimum intracellular concentration of bictegravir, emtricitabine and tenofovir (Cmim)(at 0, 12, and 48 weeks)
研究者
Anna Cruceta
Clinical Professor
Fundacion Clinic per a la Recerca Biomédica