Phase 3 Randomized Trial Evaluating the Virological Efficacy and the Tolerance of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Dakar and Yaounde
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Percentage of patients with viral load below 50 copies/mL
研究概览
简要总结
The goal of this trial is to demonstrate that new treatments are as effective as a reference triple-agent regimen in driving plasma viral load below the detection limit early during treatment (16 weeks). These simplified treatments involve fewer tablets and intakes, fixed-dose combinations, and also radically new strategies such as boosted protease inhibitor and tenofovir.
详细描述
The efficacy of antiretroviral treatments in sub-Saharan Africa has been demonstrated in cohort studies and pilot trials. The treatment regimens tested in these studies were derived from those used in pre-marketing trials conducted in industrialized countries.
However, the choice of antiretrovirals for national programs in poor countries is largely based on drug availability through the Access program, together with cost and supply considerations, rather than on field evaluations of recommended strategies.
Concomitantly with the development of antiretroviral access programs in the southern hemisphere, first-line treatments in industrialized countries have tended to become simpler, thereby improving their convenience and reducing the incidence and severity of their adverse effects. These simplified treatments involve fewer tablets and intakes, fixed-dose combinations, and also radically new strategies such as boosted protease inhibitor and tenofovir. These simplified strategies are being extensively evaluated in industrialized countries.
Long-term economic benefits will be a determining factor in the adoption of these strategies by poor countries.
Methods:
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 over 18 years for Senegal and over 21 years for Cameroon
- •HIV-1 infected patient
- •patient naive from any antiretroviral treatment
- •CD4 cell count over 50 cells per mm3
- •contraceptive method use
- •informed consent signed
排除标准
- •opportunistic infection ongoing or any other serious pathology
- •ongoing treatment with rifampicine
- •severe renal or hepatic impairment
- •HbSAg positive
- •Hemoglobine under 8g/L
- •Neutrophils under 500 cells per mm3
- •ongoing pregnancy or breastfeeding
- •treatment by contra-indicated drugs (as described in study drugs notices)
研究组 & 干预措施
1
干预措施: Tenofovir/Emtricitabine (Truvada) and Nevirapine (Drug)
2
干预措施: Tenofovir (Viread) and Lopinavir/Ritonavir (Aluvia) (Drug)
3
干预措施: Tenofovir/Emtricitabine (Truvada) and Zidovudine (Drug)
4
干预措施: Tenofovir/Emtricitabine/Efavirenz (Atripla) (Drug)
结局指标
主要结局
Percentage of patients with viral load below 50 copies/mL
时间窗: week 16
次要结局
- quality of life parameters, observance(J0, W4, W8, W12, W16, W24, W36, W48, W72, W96)
- Percentage of patients with viral Load under 50 copies/ml and under 400 copies/ml(W4, W12, W24, W36, W72, and W96)
- Severe adverse event onset, metabolic alterations, lipodystrophia(J0, W16, W24, W48, W72, W96)
- Residual ARV plasmatic concentration(W4, W48)
- CD4 count evolution(J0, W4, W16, W24, W36, W48, W72, W96)