Acute HIV Infection Observational Study
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Acute HIV-1 Infection Prospective Cohort Study|
- Prevalence of acute HIV infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Characteristics of transmitted virus in acute HIV infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Immune responses contributing to viral control and/or protection against HIV infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Genetic factors contributing to early virus control and/or protection from HIV infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Clinical, laboratory, and behavioral characteristics of individuals at diverse sites with acute HIV infection and their sexual partners, and appropriate controls [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Proven acute HIV-1 infection
Sexual partners of members of Group 1
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.
|Uganda Virus Research Institute||Recruiting|
|Contact: Christine Watera 011-256-772562912 firstname.lastname@example.org|
|Principal Investigator: Pontiano Kaleebu|
|Study Chair:||Myron S. Cohen, MD||Medicine, Microbiology, and Immunology and Public Health, Division of Infectious Diseases, University of North Carolina Center for Infectious Diseases|