A Multicentre Trial of Second-line Antiretroviral Treatment Strategies in African Adults Using Atazanavir or Lopinavir/Ritonavir (ALISA)
A Multicenter Phase III Trial of Second-line Antiretroviral Treatment Strategies in African Adults (Tanzania Ans South Africa) Using Atazanavir or Lopinavir/Ritonavir
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.
研究概览
研究类型
阶段
- 第三阶段
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Arm A : Lopinavir
Emtricitabine/tenofovir :
Lopinavir/ritonavir :
|
Evaluation of second line antiretroviral regimen including boosted lopinavir
|
|
实验性的：Arm B : Atazanavir
Lamivudine/tenofovir :
Atazanavir/ritonavir :
|
Evaluation of second line antiretroviral regimen including boosted atazanavir
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Virological response
大体时间：48 weeks
|
Proportion of patients with plasma HIV RNA < 50 copies/mL
|
48 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Virological response
大体时间：12 and 24 weeks
|
Proportion of patients with plasma HIV RNA < 400 copies/mL
|
12 and 24 weeks
|
|
Viral resistance
大体时间：12, 24 and 48 weeks
|
Incidence of resistance mutations after treatment failure (HIV RNA < 1000 copies/mL)
|
12, 24 and 48 weeks
|
|
Clinical course of HIV infection
大体时间：Up to 48 weeks
|
Mortality, occurence of clinical events stage 3 or 4 (WHO classification), immune reconstitution sundrome, non-AIDS clinical events including bacterial infections
|
Up to 48 weeks
|
|
Tolerance assessment
大体时间：24 and 48 weeks
|
Proportion of adverse events related to antiretroviral treatment, proportion of treatement discontinuations due to antiretroviral side effect, variation of biological parameters and metabolic markers between second line antiretroviral initiation and 24/48 weeks.
|
24 and 48 weeks
|
|
Adherence assessment
大体时间：At each protocol visit : week 2, 4, 12, 24, 36 and 48
|
Measurement of pills consumption at each visit, face-to-face questionnaire with the pharmacist
|
At each protocol visit : week 2, 4, 12, 24, 36 and 48
|
|
Hepatitis B evaluation
大体时间：At entry
|
Prevalence of HBs AG, HBe Ag, HBV viremia, and HBV asociated drug resistance mutations at baseline
|
At entry
|
|
Immunologic response
大体时间：24 and 48 weeks
|
Variation of circulating total and CD4+ lymphocyte count between second line treatment initiation and 24 weeks/48 weeks
|
24 and 48 weeks
|
合作者和调查者
合作者
调查人员
- 首席研究员：Eric Delaporte、Institut de Recherche pour le Developpement, France
- 首席研究员：Issakwisa Mwakyula、NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital, Tanzania
- 首席研究员：Mzileni O Mogiyana、University of Limpopo
- 首席研究员：Alexandra Calmy、University of Geneva, Switzerland
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ANRS 12221 ALISA
- IP.07.33011.004 (其他赠款/资助编号：EDCTP)
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