NCT01917175已完成不适用
Research Platform " Early Identification and Treatment of Early HIV Infection in Côte d'Ivoire "
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 511
- 试验地点
- 2
- 主要终点
- Natural history of HIV infection in Sub-Saharan Africa
研究概览
简要总结
Set-up of a biobank for patients with an estimated date of infection seroconverters: store plasma and cells samples at initial contact and during follow-up for future analysis and analysis in international collaborative cohort seroconverters.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •patients included in the last Primo-CI ANRS 1220 protocol
- •All HIV infected individuals diagnosed during a blood donation with an estimated date of HIV seroconversion that will respect the following criteria: (i) age ≥18 (ii) HIV-1 or HIV-1+2 infected, (iii) HIV-seronegative at the preceding donation; (iv) who returned to the clinic to be informed of their HIV test result (v) with an HIV serology confirmed with two specific tests in two different laboratories (vi) who have never received ART for curative purpose
- •informed on study objectives and have a signed informed consent.
排除标准
- •Patient living outside of Abidjan
结局指标
主要结局
Natural history of HIV infection in Sub-Saharan Africa
时间窗: 12 months after ART initiation
Plasmatic HIV viral load and CD4 measured every six months and incidence of morbidity events associated with AIDS
次要结局
- Evolution of markers of HIV infection and immunity(12 months after ART initiation)
- Metabolic and lipodystrophic disorders(12 months after ART initiation)
- Incidence of pregnancies(12 months after ART initiation)
- Estimate the probability of disease progression after HIV seroconversion(12 months after ART initiation)
- Viral genetic diversity description(Inclusion (J0))
- Primary resistance to antiretroviral treatment(Inclusion (J0))
- T lymphocytes activation and evolution in seroconverters(12 months after ART initiation)
研究者
研究点 (2)
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