Acute HIV Infection Observational Study
- Conditions
- HIV Infections
- Registration Number
- NCT00296660
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1300
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Genetic factors contributing to early virus control and/or protection from HIV infection Throughout study Clinical, laboratory, and behavioral characteristics of individuals at diverse sites with acute HIV infection and their sexual partners, and appropriate controls Throughout study Prevalence of acute HIV infection Throughout study Characteristics of transmitted virus in acute HIV infection Throughout study Immune responses contributing to viral control and/or protection against HIV infection Throughout study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Kamuzu Central Hosp. CHAVI CRS
🇲🇼Lilongwe, Malawi
Uganda Virus Research Institute, MRC/UVRI Uganda Research Unit on AIDS CHAVI CRS
🇺🇬Entebbe, Uganda
CAPRISA eThekwini CHAVI CRS
🇿🇦Durban, KwaZulu-Natal, South Africa
Univ. of Witwatersrand, Chris Hani Baragwanath Hosp., Reproductive Health Research Unit CHAVI CRS
🇿🇦Johannesburg, Gauteng, South Africa
UNC School of Medicine, Div. of Infectious Diseases CHAVI CRS
🇺🇸Chapel Hill, North Carolina, United States
Queen Elizabeth Hosp., Malawi College of Medicine-Johns Hopkins Research Project CHAVI CRS
🇲🇼Blantyre, Malawi
Aurum Institute for Health Research CHAVI CRS
🇿🇦Klerksdorp, South Africa
Duke Univ. Med. Ctr., Infectious Diseases Clinic CHAVI CRS
🇺🇸Durham, North Carolina, United States
Kilimanjaro Christian Med. Ctr. CHAVI CRS
🇹🇿Moshi, Tanzania