NCT00158457已完成3 期
Pilot Trial to Evaluate the Efficacy and Tolerance of a Simple Once Daily Combined Regimen Including Tenofovir (TDF), Emtricitabine (FTC) and Efavirenz (EFV) in HIV-1 Infected Patients Naive to Prior Antiretroviral Treatment in Senegal
French National Agency for Research on AIDS and Viral Hepatitis2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2004年6月1日最近更新:
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相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Evaluation of the antiretroviral efficacy as first line treatment assessed as percentage of patients with viral load below 400 copies/ml at week 48 in the intention to treat (ITT) population
研究概览
简要总结
In the context of Sub-saharian Africa, this trial evaluate one of the most simple treatment available for HIV-1 infected patients. The combination proposed is a triple antiretroviral therapy with only one intake of 3 pills per day. This combination has already been studied in the North countries.
Here in Senegal, the efficacy and the compliance to treatment will be evaluated after 24, 48 and 96 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented infection with HIV-1 (ELISA- Western Blot)
- •Outpatient of masculine or feminine gender
- •In female patients any risk of pregnancy must be avoid: women at least 1 year past menopause or being confirmed sterile or having an effective contraceptive device
- •No previous treatment with antiretroviral therapy
- •CDC group C (except tuberculosis if CD4 count is over 350 /ml), CDC group B with CD4+ count under 350/ml and CDC group A with CD4 count under 200/ml.
- •Patient has provided informed written consent
- •Patient must agree not to take any concomitant medication throughout the duration of the study without first informing the investigator
排除标准
- •Deficiency of the patient rendering participation in the study or understanding of the information imparted difficult or even impossible
- •Patient participating in a different clinical study
- •Presence of serious or developing pathology
- •Severe liver failure (TP under 50% et bilirubinemia over 3 LSN)
- •Thrombocytopenia with platelet level under 50 000 cells /ml
- •Known severe renal pathology (creatinine clearance under 50 ml/min)
- •Clinical or biological problem corresponding to indications of grade over or equal 3 of WHO classification
- •Karnofsky under 70 percent
- •Opportunistic infections
- •Patients taking medications not recommended in the context of the protocol
结局指标
主要结局
Evaluation of the antiretroviral efficacy as first line treatment assessed as percentage of patients with viral load below 400 copies/ml at week 48 in the intention to treat (ITT) population
时间窗: S48
次要结局
- Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml(S24 and S96)
- Viral load evolution(S24 and S48)
- Genotype resistance profile evaluation failing patients(S24, S48, S96)
- Immune benefits of the combination
- Plasma concentrations of FTC, TDF and EFV(S4)
- Adverse events clinic and lipids
- Compliance(S48 and S96)
研究者
研究点 (2)
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