Expanded Access to Antiretroviral Therapy in Africa: Assessment of the Patients' Management in District Hospitals With a Simplified Follow-up Approach (ANRS 12110 STRATALL)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 459
- 试验地点
- 9
- 主要终点
- Increase in the CD4 cell count measured with a FACSCount apparatus after 24 months of antiretroviral therapy
研究概览
简要总结
Access to antiretroviral therapy (ART) is still limited in Africa (11% of patients in immediate need in June 2005). Face to the scope of the need and the constraints (unavailability and cost of viral load and CD4 cell count, lack of physicians...), WHO has developed a follow-up approach based on a simplified monitoring. However, this "simplified" approach which represents a major stake for the expanded access to ART has been little evaluated against the gold standard approach.
详细描述
Justification
Access to antiretroviral therapy (ART) is still limited in Africa (11% of patients in immediate need in June 2005). Face to the scope of the need and the constraints (unavailability and cost of viral load and CD4 cell count, lack of physicians...), WHO has developed a follow-up approach based on a simplified monitoring. This "simplified" approach restricting the use of complementary exams including biologic criteria of effectiveness and tolerability, some people consider this approach as dangerous for the patient but also for the community (rapid emergence of resistances) and that it would be preferable to treat less patients and only with the gold standard approach. In practice, this "simplified" approach which represents a major stake for the expanded access to ART has been little evaluated against the gold standard approach.
Objectives
Main objective: To compare the increase in the CD4 cell count in patients receiving ART with a "simplified" approach and in those treated with the gold standard approach in district hospitals.
Secondary objectives: To compare between the two approaches the virologic effectiveness, survival, treatment interruptions, number of patients lost to follow-up, clinical progression, clinical and biologic tolerability, adherence, emergence of drug resistances, impact on patients' daily life, acceptability by the patients and health professionals, and cost-effectiveness performances.
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
- •Men or women aged at least 18 years
- •Living in the health district of the hospital attended
- •Confirmed HIV-1 group M infection
- •Meeting one of the following criteria:
- •Stage III or IV (WHO classification)
- •Stage II (WHO classification) and total lymphocytes count ≤ 1200/mm3
- •Patient agreeing on monthly follow-up and treatment for 24 months
- •Signed informed consent
排除标准
- •HIV-1 group O or N, or HIV-2 infection
- •HIV-1 primary infection
- •Progressive tuberculosis in treatment and total lymphocytes count > 1200/mm3
- •Progressive tumor or malignant lymphoma (except cutaneous or mucous Kaposi sarcoma)
- •Progressive psychiatric disorder
- •Hepatocellular disorder
- •History of antiretroviral therapy
- •Pregnancy
结局指标
主要结局
Increase in the CD4 cell count measured with a FACSCount apparatus after 24 months of antiretroviral therapy
时间窗: 24 months
次要结局
- Percentage of patients with viral load below 400 copies/ml and 50 copies/ml, respectively (Abbott RealTime HIV-1)(12 and 24 months)
- Survival probability(Through out the trial)
- Incidence of clinical events (WHO stage III or IV)(Through out the trial)
- Probability of treatment interruption(Through out the trial)
- Probability of patients lost to follow-up(Through out the trial)
- Impact on patients' daily life(Through out the trial)
- Percentage of patients with drug resistance(12 and 24 months)
- Cost-effectiveness ratio(24 months)
- Incidence of side effects(Through out the trial)
- Percentage of adherence(12 and 24 months)
- Acceptability by the patients and health professionals of both approaches(12 and 24 months)