Multicentric Randomised Controlled Trial Assessing the Efficacy of Two Strategies of Structured Treatment Interruption of Highly Active Antiretroviral Therapy (HAART) Compared With a Continuous HAART in HIV- Infected Adults in Abidjan
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 840
- 试验地点
- 10
- 主要终点
- To assess the non-inferiority at 24 months of two STI strategies of HAART compared with a continuous HAART in terms of :
研究概览
简要总结
Interrupting HAART during limited periods of time ("structured treatment interruption : STI") could entail benefits (better long term tolerance, lower drug-induced viral resistance, lower cost) but also concomitant risks (lower efficacy, higher drug-induced viral resistance). At present, the benefit/risk ratio of STI is unclear. Several STI trials are in progress in industrialised countries. This trial aim at assessing the benefits and risks of two different STI strategies in West Africa.
详细描述
The objective of this study is to assess the non-inferiority of two strategies of structured treatment interruption (STI) of highly active antiretroviral treatment (HAART) compared with a continuous HAART.
It's a multicentric open labeled randomised non-inferiority trial, which takes place in 5 health care centres in Abidjan, the economic capital city of Cote d'Ivoire
The trial was designed in two phases :
- Pre-randomisation phase : 840 HAART-naive HIV-infected adults start the following continuous HAART regimen: zidovudine-lamivudine in combination with
- preferably efavirenz, for HIV-1 infected men, and HIV-1 infected women with an effective contraception and no history of nevirapine-containing p-MTCT (prevention of mother to child transmission);
- ritonavir-indinavir, for HIV-2 infected patients, women not desiring contraception, and women with a past history of p-MTCT with nevirapine.
- Trial phase : After at least six months on continuous HAART in the pre-randomisation phase, patients who meet success criteria (CD4 count over 350/mm3, undetectable viral load, absence of current opportunistic infection) are randomised into three arms :
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
- •Informed consent
- •18 years old or more
- •CD4 count between 150 and 350 per mm3 (or CD4 percentage between 12.5 and 20 percent)
- •no past history of curative antiretroviral therapy
- •residence in Abidjan
排除标准
- •pregnancy
- •severe renal failure
- •severe hepatic failure
- •severe neuropsychiatric disease
结局指标
主要结局
To assess the non-inferiority at 24 months of two STI strategies of HAART compared with a continuous HAART in terms of :
Percentage of patients with CD4 count over 350 per mm3
Incidence of severe morbidity
Incidence of mortality
次要结局
- Cost-utility
- To compare at 24 months two STI strategies of HAART with a continuous HAART in terms of :
- HIV resistance to antiretroviral drugs
- Compliance to treatment