A Multicenter Phase III Trial of Second-line Antiretroviral Treatment Strategies in African Adults (Tanzania Ans South Africa) Using Atazanavir or Lopinavir/Ritonavir
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Virological response
研究概览
简要总结
In the well recognized context of HIV infection chronicity, it is now crucial to identify and evaluate effective, well tolerated and affordable second line regimen in resources limited countries where patients often change treatment after a long period of viral replication while on first line regimen.
This multicentre international, randomized, non-blinded phase III trial aim to demonstrate the non-inferiority of a generic lamivudine-tenofovir-atazanavir/ritonavir regimen (daily intake) as compared to a standard emtricitabine-tenofovir-lopinavir/ritonavir (twice daily intake)regimen for second line HIV-1 treatment. by stratifying on the viral load level (between 1000 and 5000 copies/mL versus > 5000 copies/mL) at inclusion, this trial will also allow to evaluate the optimum moment for instituting the second-line treatment.
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
- •age 18 and above
- •out patient
- •documented HIV-1 infection
- •first line treatment failure:
- •after first-line antiretroviral treatment with a combination including a non-nucleoside reverse transcriptase inhibitor and two nucleoside reverse transcriptase inhibitors
- •two measurements of plasma HIV RNA levels > 1000 copies/mL after at least 6 months of uninterrupted treatment or without any major modification
- •satisfactory compliance (>80%) to 1st line antiretroviral treatment
- •signed informed consent
- •agreement for contraception for women of childbearing age
排除标准
- •HIV-2 infection or HIV-1/HIV-2 coinfection
- •uncontrolled, ongoing opportunistic infection or of any severe or progressive disease including active TB
- •first line antiretroviral treatment with a protease inhibitor or tenofovir
- •ongoing treatment with rifampicin
- •severe hepatic insufficiency (PT < 50%)
- •ALT < 3 times the upper limit of normal
- •creatinine clearance calculated by Cockcroft's formula < 50 mL/min
- •Hb <=8 g/dL; platelets < 50,000 cells/mm3; neutrophils < 500 cells/mm3
- •pregnancy and lactation
研究组 & 干预措施
Arm A : Lopinavir
Emtricitabine/tenofovir :
- TDF300mg.FTC200mg (Fixed Dose Combination)
- 1 tablet per day
Lopinavir/ritonavir :
- LPV200mg/RTV50mg
- 2 tablets twice a day
干预措施: Lopinavir (Drug)
Arm B : Atazanavir
Lamivudine/tenofovir :
- 3TC300mg/TDF300mg (Fixed Dose Combination)
- 1 tablet per day
Atazanavir/ritonavir :
- ATV300mg/RTV100mg
- 2 tablets once a day
干预措施: Atazanavir (Drug)
结局指标
主要结局
Virological response
时间窗: 48 weeks
Proportion of patients with plasma HIV RNA \< 50 copies/mL
次要结局
- Virological response(12 and 24 weeks)
- Viral resistance(12, 24 and 48 weeks)
- Clinical course of HIV infection(Up to 48 weeks)
- Tolerance assessment(24 and 48 weeks)
- Adherence assessment(At each protocol visit : week 2, 4, 12, 24, 36 and 48)
- Hepatitis B evaluation(At entry)
- Immunologic response(24 and 48 weeks)