NCT02632474已完成4 期
ART Drug Dosage Adjustment Using FSCII in Chinese HIV-infected Population
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- HIV viral load
研究概览
简要总结
The purpose of this study is to determine efficacy of the combination of low dose of Tenofovir, Efavirenz and Lamivudine in treating HIV-infection.
详细描述
The feedback system control (FSC) technique has been developed to rapidly identify optimal combinations for therapeutic purposes. Low dose of TDF+3TC+EFV combination has been test in vitro study by FSC which showed high efficacy and now the investigators apply it to human to further optimize the ART combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV antibody positive
- •HIV RNA below 10*E5 copies/ml
- •CD4 T cell count above 200 cells/ml
- •Provision of written informed consent
排除标准
- •HIV genotyping resistant to investigating drug
- •Pregnant, breastfeeding, or lactating
- •Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with treatment, assessment, compliance with the protocol, or subject safety. This would include any active clinically significant renal, cardiac, pulmonary, vascular, or metabolic (thyroid disorders, adrenal disease) illness, or malignancy
- •Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
- •Laboratory blood values:
- •Haemoglobin <7.0 grams/decilitre (g/dL)
- •Neutrophil count <500/mm3
- •Platelet count <50,000/mm3
- •Aspartate aminotransferase or Alanine transaminase >5 times Upper Limit of Normal (ULN)
- •Subjects with an estimated creatinine clearance of <50 mL/minute
研究组 & 干预措施
Low-dose
Experimental
Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)
干预措施: Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV) (Drug)
结局指标
主要结局
HIV viral load
时间窗: 48 weeks
次要结局
- CD4 Count(48 weeks)
研究者
Hongzhou Lu
Doctor
Shanghai Public Health Clinical Center
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Dosing of Tenofovir and Efavirenz in Antiretroviral TherapyHIV InfectionsNCT02945163Shanghai Public Health Clinical Center184
已完成
2 期
Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/EfavirenzHIVNCT01160120The HIV Netherlands Australia Thailand Research Collaboration100
已完成
2 期
Maternal TDF and FTC to Reduce NNRTI Resistance Mutations After Intrapartum NVPHIVPregnancyNCT00204308University of North Carolina, Chapel Hill400
已完成
4 期
Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex.Renal AngiomyolipomaNCT03525834Novartis Pharmaceuticals40
已完成
1 期
VX-950-TiDP24-C134: Drug-drug Interaction Trial Between Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir on Healthy VolunteerHCVHepatitis CHIVAIDSNCT00828789Tibotec BVBA20