A Long-term Follow-up Study for HIV-infected Individuals Who Have Participated in HIV-NAT Study Protocols
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 2
- 主要终点
- HIV infection
研究概览
简要总结
With HIV/AIDS increasingly considered a chronic disease, 24-, or 48-week data from antiretroviral studies are no longer sufficient. Only with long-term follow-up and outcome data will shed some much-needed light on the answers of questions that have stumped us for several years. Data from a large observational cohort of patients treated with combination antiretroviral therapy will provide further insights into the long-term safety and durability of various antiretroviral therapeutic approached, the efficacy of HIV viral load and CD4 cell counts as predictors of disease progression and mortality, and the importance of adherence.
详细描述
Primary Objective:
To collect and evaluate long-term clinical outcomes of HIV infected participants previously enrolled in HIV-NAT trials.
Secondary Objective:
To Assess:
- Long-term consequences of initiation of antiretroviral as predicted by baseline CD4 cell count and/or baseline plasma HIV RNA level
- Incidence of lipodystrophy and other metabolic complications in three different groups of patients initially treated with NRTI-based regimens, NNRTI-based regimens, or PI-based regimens
- Class-specific incidence of lipodystrophy and metabolic complications such as d4T versus AZT, nevirapine versus efavirenz and individual PIs (IDV, SQV, Kaletra, and atazanavir)
- Resistance profiles in patients on different antiretroviral regimens
- Long-term consequences of antiretroviral agents on cardiovascular, renal, hepatic, and endocrine function, skin, gastrointestinal system and urogentital tract
- Incidence of opportunistic infections or malignancy including hepatocarcinoma in patients with HIV/HCV or HIV/HBV co-infection
- Immune recovery syndrome
- Adherence to different antiretroviral regimens
- Quality of life
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
- •HIV infected patients( children and adults) previously participated HIV-NAT studies
- •HIV infected patients( children and adults) currently participate in HIV-NAT trials
- •Able to provide written consent
排除标准
- •Unable to provide written consent
结局指标
主要结局
HIV infection
时间窗: 30 years
This cohort will collect various information such as but not limited to: comorbidity, mortality, cardiovascular, neurological clinical data, treatment history, serious adverse events, PBMCs, clinical outcomes, virological outcomes, resistance, failure, aging, other opportunistic infections, etc
次要结局
未报告次要终点