跳至主要内容
临床试验/NCT00296660
NCT00296660已完成不适用

Acute HIV-1 Infection Prospective Cohort Study

National Institute of Allergy and Infectious Diseases (NIAID)9 个研究点 分布在 5 个国家目标入组 1,300 人开始时间: 2006年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,300
试验地点
9
主要终点
Genetic factors contributing to early virus control and/or protection from HIV infection

研究概览

简要总结

The purpose of this study is to collect data and body fluid samples from people with acute or established HIV infection and from HIV uninfected people. Data from this study will be used to better understand properties of HIV, including HIV transmission and the differences between acute and established HIV infections.

详细描述

Previous studies have identified strategies for the large-scale identification of acute HIV infections. One system using such strategies has already been implemented in North Carolina, and this system will be used in this study run by the Center of HIV/AIDS Vaccine Immunology (CHAVI). This study will collect data on the mechanism of HIV transmission and the genetic, biologic, antigenic, and structural characteristics of the virus. The study will enroll HIV infected people with acute HIV infection and their sexual partners, people with established HIV infection, and HIV uninfected people.

This study will last 96 weeks. Group 1 participants will be people with acute HIV infection. These participants will have 15 study visits; some visits will include a physical exam and medical history. Group 1 will also be asked to complete a sexual behavioral assessment at study entry and every 12 weeks thereafter. Group 2 participants will be people with established HIV infection. Group 3 participants will be HIV uninfected people. Groups 2 and 3 will have 10 study visits; some visits will include a physical exam and medical history. Groups 2 and 3 will also be asked to complete a sexual behavioral assessment at study entry, every 12 weeks until Week 72, and Week 96. Group 3 will undergo HIV testing at each visit and will receive pre- and post-test counseling.

At each visit, participants will undergo HIV safe sex counseling and will update their locator information. Blood, genital secretion, and breast milk collection will also occur at each visit.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Genetic factors contributing to early virus control and/or protection from HIV infection

时间窗: Throughout study

Clinical, laboratory, and behavioral characteristics of individuals at diverse sites with acute HIV infection and their sexual partners, and appropriate controls

时间窗: Throughout study

Prevalence of acute HIV infection

时间窗: Throughout study

Characteristics of transmitted virus in acute HIV infection

时间窗: Throughout study

Immune responses contributing to viral control and/or protection against HIV infection

时间窗: Throughout study

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (9)

Loading locations...

相似试验

Acute HIV Infection Observational Study | 临床试验