Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon
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
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Yaounde、喀麦隆
- Hôpital Central
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Yaounde、喀麦隆
- Hôpital de la CNPS
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
1
HIV-1 group O infected patients
|
The first line regimen is adapted according to the hemoglobin level and the AgHBs status :
|
|
2
HIV-1 group M infected patients
|
The first line regimen is adapted according to the hemoglobin level and the AgHBs status :
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml
大体时间：48 weeks
|
48 weeks
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Proportion of patients with plasmatic HIV viral load bellow 60 copies / ml
大体时间：24 and 96 weeks
|
24 and 96 weeks
|
|
Early and late slope of viral load decrease
大体时间：between weeks 2 and 12, and week 24
|
between weeks 2 and 12, and week 24
|
|
Early and late slope of CD4 counts increase
大体时间：between weeks 2 and 12, and week 24
|
between weeks 2 and 12, and week 24
|
|
Proportion of patients with a stabilized CD4 counts gain over 50%
大体时间：96 weeks
|
96 weeks
|
|
Time to virological failure
大体时间：Through out the trial
|
Through out the trial
|
|
Resistance mutation profile when virological failure
大体时间：Through out the trial
|
Through out the trial
|
|
Clinical evaluation : proportion of adverse events, AIDS related events, deaths, morphologic modification
大体时间：Through out the trial
|
Through out the trial
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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