Efficacy and Safety of Switching From AZT to Tenofovir
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
- Changes in subcutaneous adipose tissue assessed by DEXA
研究概览
简要总结
To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in HIV-infected patients
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
- •HIV-infection with undetectable viral load
- •Antiretroviral treatment including Retrovir for more than three months
- •If fertile female: Negative pregnancy test and use of safe contraception
- •Negative HBs-antigen titer
排除标准
- •Prior treatment with abacavir or tenofovir
- •Resistance towards abacavir or tenofovir
- •Tissue type HLA-B5701
- •Renal disease
- •Diabetes Mellitus
- •Osteoporosis
- •Pregnant or lactating subjects
- •Intravenous drug abuse
- •Hypersensitivity towards drugs or active ingredient used
- •ALAT > 5 times upper normal level
- •Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance
研究组 & 干预措施
1
Tenofovir
干预措施: Tenofovir disoproxil fumarate (Drug)
2
Abacavir
干预措施: Abacavir (Drug)
结局指标
主要结局
Changes in subcutaneous adipose tissue assessed by DEXA
时间窗: Week 0, 24, 48, 96
Renal function measured by Cystatin-C and creatinine clearance
时间窗: Weeks 0, 4, 8, 12, 24, 24, 48, 96
Levels of renal tubule function markers in blood and urine
时间窗: Weeks 0, 12, 24, 48, 96
Bone mass assessed by DEXA
时间窗: Weeks 0, 24, 48, 96
Levels of bone turnover markers in blood and urine
时间窗: Weeks 0, 12, 24, 48, 96
Insulin resistance
时间窗: Weeks 0, 12, 24, 48, 96
Changes in body composition assessed by patient questionnaire and standardized examination by physician
时间窗: Weeks 0, 12, 24, 48, 96
次要结局
- Patients with viral load < 40 copies/ml(Weeks 0, 4, 8, 12, 24, 48, 96)
- CD-4 cell count(Weeks 0, 4, 8, 12, 24, 48, 96)
- Fasting triglycerides, HDL and LDL(Weeks 0, 12, 24, 48, 96)
- Development of resistance mutations(Weeks 0, 12, 24, 48, 96)
- Development of adverse events and serious adverse events(Weeks 0, 4, 8, 12, 24, 48, 96)