Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml
研究概览
简要总结
Infections with HIV-1 group O are found in 1 to 3 % of persons living with HIV in Cameroon. The natural history and treatment response is not well understood. The natural resistance to non nucleoside reverse transcriptase inhibitors and their possible low sensitivity to protease inhibitors complicate the choice of an adequate treatment options.
This observational study is aimed at evaluating the antiretroviral treatment response of HIV-1 group O infected patients in comparison with HIV-1 group M infected patients. The proposed standardized follow-up will facilitate a better understanding of the natural history and treatment specificities to improve the patients management.
This is a non randomized study, open label, with standardized follow-up. A total of 171 patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •HIV-1 group O or group M infection
- •No history of antiretroviral treatment (except for PMTCT)
- •Criteria for treatment initiation according to the Cameroons national guidelines
排除标准
- •Ongoing traditional treatment which could interfere with hepatic function
- •Ongoing treatment with rifabutin, rifampicin or rifampin
- •Acute hepatitis B infection
- •Pregnancy or lactating mother
- •HIV-1 group O and group M co-infection
研究组 & 干预措施
1
HIV-1 group O infected patients
干预措施: Treatment initiation for HIV-1 group O infected patients (Drug)
2
HIV-1 group M infected patients
干预措施: Treatment initiation for HIV-1 group M infected patients (Drug)
结局指标
主要结局
Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml
时间窗: 48 weeks
次要结局
- Time to virological failure(Through out the trial)
- Proportion of patients with a stabilized CD4 counts gain over 50%(96 weeks)
- Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml(24 and 96 weeks)
- Early and late slope of viral load decrease(between weeks 2 and 12, and week 24)
- Early and late slope of CD4 counts increase(between weeks 2 and 12, and week 24)
- Resistance mutation profile when virological failure(Through out the trial)
- Clinical evaluation : proportion of adverse events, AIDS related events, deaths, morphologic modification(Through out the trial)