Clinical trial NCT00296660: Acute HIV Infection Observational Study
Official title: Acute HIV-1 Infection Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Acute Infection
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2006-02-27
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 1300 with either an acute HIV-1 infection, established HIV-1 infection, or without HIV-1 infection will be enrolled. Sexual partners of those with an acute infection will also be enrolled.

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.

Eligibility criteria: Inclusion Criteria for All Participants:

* Willing to receive HIV test results
* Willing to provide updated locator information during the study

Inclusion Criteria for Group 1:

* Acute HIV infection OR sexual partner of a Group 1 participant with acute HIV infection

Inclusion Criteria for Group 2:

* Established HIV infection (positive HIV antibody test and positive HIV Western blot)

Inclusion Criteria for Group 3:

* HIV uninfected

Exclusion Criteria for All Participants:

* Plan to relocate out of the area during the study or have a job or other obligations that may require long absences from the area
* Currently on antiretroviral therapy. Women who previously took antiretroviral therapy for the prevention of mother-to-child transmission of HIV are not excluded.
* Any other condition that, in the opinion of the investigator, may interfere with the study

Primary outcomes:
measure: Prevalence of acute HIV infection
timeFrame: Throughout study
measure: Characteristics of transmitted virus in acute HIV infection
timeFrame: Throughout study
measure: Immune responses contributing to viral control and/or protection against HIV infection
timeFrame: Throughout study
measure: Genetic factors contributing to early virus control and/or protection from HIV infection
timeFrame: Throughout study
measure: Clinical, laboratory, and behavioral characteristics of individuals at diverse sites with acute HIV infection and their sexual partners, and appropriate controls
timeFrame: Throughout study
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC School of Medicine, Div. of Infectious Diseases CHAVI CRS
state: North Carolina
city: Durham
country: United States
facility: Duke Univ. Med. Ctr., Infectious Diseases Clinic CHAVI CRS
state: North Carolina
city: Blantyre
country: Malawi
facility: Queen Elizabeth Hosp., Malawi College of Medicine-Johns Hopkins Research Project CHAVI CRS
city: Lilongwe
country: Malawi
facility: Kamuzu Central Hosp. CHAVI CRS
city: Johannesburg
country: South Africa
facility: Univ. of Witwatersrand, Chris Hani Baragwanath Hosp., Reproductive Health Research Unit CHAVI CRS
state: Gauteng
city: Durban
country: South Africa
facility: CAPRISA eThekwini CHAVI CRS
state: KwaZulu-Natal
city: Klerksdorp
country: South Africa
facility: Aurum Institute for Health Research CHAVI CRS
city: Moshi
country: Tanzania
facility: Kilimanjaro Christian Med. Ctr. CHAVI CRS
city: Entebbe
country: Uganda
facility: Uganda Virus Research Institute, MRC/UVRI Uganda Research Unit on AIDS CHAVI CRS
Study officials:
affiliation: Medicine, Microbiology, and Immunology and Public Health, Division of Infectious Diseases, University of North Carolina Center for Infectious Diseases
name: Myron S. Cohen, MD
role: STUDY_CHAIR
References:
citation: Lindback S, Thorstensson R, Karlsson AC, von Sydow M, Flamholc L, Blaxhult A, Sonnerborg A, Biberfeld G, Gaines H. Diagnosis of primary HIV-1 infection and duration of follow-up after HIV exposure. Karolinska Institute Primary HIV Infection Study Group. AIDS. 2000 Oct 20;14(15):2333-9. doi: 10.1097/00002030-200010200-00014.
citation: Pilcher CD, Eron JJ Jr, Galvin S, Gay C, Cohen MS. Acute HIV revisited: new opportunities for treatment and prevention. J Clin Invest. 2004 Apr;113(7):937-45. doi: 10.1172/JCI21540.
citation: Pilcher CD, Fiscus SA, Nguyen TQ, Foust E, Wolf L, Williams D, Ashby R, O'Dowd JO, McPherson JT, Stalzer B, Hightow L, Miller WC, Eron JJ Jr, Cohen MS, Leone PA. Detection of acute infections during HIV testing in North Carolina. N Engl J Med. 2005 May 5;352(18):1873-83. doi: 10.1056/NEJMoa042291.
citation: Pilcher CD, McPherson JT, Leone PA, Smurzynski M, Owen-O'Dowd J, Peace-Brewer AL, Harris J, Hicks CB, Eron JJ Jr, Fiscus SA. Real-time, universal screening for acute HIV infection in a routine HIV counseling and testing population. JAMA. 2002 Jul 10;288(2):216-21. doi: 10.1001/jama.288.2.216.
citation: Soogoor M, Daar ES. Primary human immunodeficiency virus type 1 infection. Curr HIV/AIDS Rep. 2005 Jun;2(2):55-60. doi: 10.1007/s11904-005-0019-1.