ANRS 12406 EvvA Study (EvvA)
Virological Failure and HIV Drug Resistance Among Adolescents Receiving Antiretroviral Treatment in Cameroon
ANRS 12406 EvvA is an observational, longitudinal and monocentric study evaluating the virological success rate in HIV-infected adolescents on antiretroviral therapy in Cameroon.
The main objective of the study is to estimate the rate of virological suppression among adolescents on antiretroviral therapy for more than 6 months in Cameroon
研究概览
地位
条件
详细说明
At the end of 2017, HIV-AIDS affects more than 36 million people worldwide, more than three-quarters of whom live in sub-Saharan Africa, and a quarter of the infections are among young people and adolescents. Every hour, 4 adolescents (aged 15-19) are newly infected with HIV in the world, and 3 of them are adolescents. Three infections occur in sub-Saharan Africa, and for five adolescents living with HIV, there are seven girls (aged 10 to 19) in the same situation. This gender disparity increases when adolescents reach adulthood. This group of the population may well deserve the term "key and vulnerable population". In the era of international commitment to end the AIDS epidemic by 2030, especially to stop new infections, it is essential not to neglect part of the epidemic because it would effectively represent a reservoir for maintaining the epidemic and make these eradication goals impracticable. Data on virological success among adolescents on antiretroviral treatment are generally scarce and this is much more striking in Central Africa. Also, information on the frequency of emergence of resistant viruses and the consequences for the effectiveness of available treatments is rare. However, in the absence of such data, it is difficult, if not impossible, to take the right decisions to improve the care and monitoring of adolescents. In addition, the few available data indicate high virological failure rates and high frequencies of drug resistance, which may indicate a need to further investigate virological failure events in this population.
This study will be conducted in Cameroon among 289 adolescents during 9 months, where access to biological monitoring is a major challenge, especially with low access to viral load testing. The results of this project will inform on the current state of success of ARV treatments in this population. Moreover, the other goal of this study is to conclude on the need to conduct a larger study at the national or regional level according to the results obtained
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Avelin F AGHOKENG, PhD
- 电话号码:+(33)467415958
- 邮箱:avelin.aghokeng@ird.fr
研究联系人备份
- 姓名:Ida C Penda, PhD
- 电话号码:+(237)7770 31 55
- 邮箱:calix.penda@gmail.com
学习地点
-
-
-
Douala、喀麦隆
- 招聘中
- Hôpital Laquinitie de Douala
-
接触:
- Ida C Penda, PhD
- 电话号码:+(237)7770 31 55
- 邮箱:calix.penda@gmail.com
-
-
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:
- Being adolescent (aged 10 to 19) on antiretroviral therapy and followed at the Laquintinie Hospital (Douala Cameroon)
- HIV-1 infection
- Duration of antiretroviral therapy ≥ 6 months regardless of antiretroviral regimen
- For emancipated adolescents: obtaining informed consent signed by the adolescent
- For unemancipated adolescents:
- Obtaining informed consent signed by the legal representative (parent(s) or guardian(s))
- Obtaining the assent of adolescents able to understand the study (maturity and knowledge of HIV status)
Exclusion Criteria:
- Infection with HIV-1 or HIV-1/HIV2 co-infection
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:横截面
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Viral load suppression after ≥ 6 months of antiretroviral therapy
大体时间:Day 0
|
Proportion of participants with HIV-1 RNA <1000 copies / ml after ≥ 6 months of antiretroviral therapy
|
Day 0
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Drug resistance after ≥ 6 months of antiretroviral therapy
大体时间:3 months
|
Proportion of participants with HIV-1 RNA ≥ 300 copies / ml and presence of antiretroviral-resistant virus (ARV) after ≥ 6 months of antiretroviral therapy
|
3 months
|
合作者和调查者
合作者
调查人员
- 研究主任:Avelin F AGHOKENG, PhD、Institut de Recherche pour le Developpement
- 首席研究员:Ida C PENDA、Hôpital Laquinitie de Douala
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.