Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,982
- 试验地点
- 77
- 主要终点
- Absolute number and percentage of naive cells, including CD4, CD45RA, and CD62L cells
研究概览
简要总结
The purpose of this study is to determine what combinations of anti-HIV drugs work best in patients treated over several years. The study will also assess the occurrence of side effects and opportunistic infections in patients with low viral loads compared to those with higher viral loads.
详细描述
A compilation of outcomes of various antiretroviral therapies would be beneficial when evaluating which strategies are most effective in long-term treatment of HIV-1. Using data from present and recently completed studies, this study will collect information on therapies and their control of HIV infection and maintenance of durable suppression of HIV-1 replication.
No treatment is provided by this study, but patients will continue to receive highly active antiretroviral therapy (HAART) from other studies in which they are coenrolled. Blood and urine collection will occur at study entry and periodically throughout the study. Women may undergo pelvic exams and Pap smears. Portions of blood samples will be stored to evaluate genotypic/phenotypic susceptibility testing. Medical histories, physical exams, and questionnaires will be completed periodically.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Absolute number and percentage of naive cells, including CD4, CD45RA, and CD62L cells
时间窗: Measured 144 weeks after randomization
Absolute number and percentage of memory cells, including CD4, CD45RO+, and CD45RA- cells
时间窗: Measured 144 weeks after randomization
Successive suppressed viral load measures
时间窗: Measured 144 weeks after randomization
Genotypic or phenotypic resistance
时间窗: Measured at baseline and study completion
Absolute number and percentage of CD4 and CD8 T cells
时间窗: Measured 144 weeks after randomization
Complications of HIV disease, including survival, HIV-related opportunistic infections, HIV-related non-opportunistic complications, adverse effects of antiretroviral therapies of grade three or greater
时间窗: Measured throughout
Levels of immune activation markers, including CD8, CD38, and HLA-DR cells
时间窗: Measured 144 weeks after randomization
次要结局
- Metabolic and neurologic complications(Measured at baseline, Week 16, Week 48, and study completion)
- Effect of gender, use of hormonal therapies, presence or absence of menopause on short- and long-term virologic suppression, and pap smear abnormalities(Measured at baseline, Week 48, and study completion)
- HIV-1 latency or replication in tissue or cellular reservoirs(Measured at baseline, Week 16, Week 48, and study completion)
- Syncytium and non-syncytium inducing (SI/NSI) phenotype(Measured at baseline, Week 16, Week 48, and study completion)
- Immune responses to antigens such as cytomegalovirus (CMV), Myobacterium avium complex (MAC), Candida, and HIV(Measured 144 weeks after randomization)
- Plasma concentrations of antiretroviral medications other than nucleoside/tide reverse transcriptase inhibitors (NRTIs)(Measured at baseline, Week 16, and study completion)
- Quality of life scores(Measured at baseline, Week 48, and study completion)
- Subject-reported patterns of adherence(Measured at baseline, Week 48, and study completion)
- Estimated inpatient, outpatient, and total costs(Measured at study completion)