Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1300 participants
OBSERVATIONAL
2006-06-30
2013-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Proven acute HIV-1 infection
No interventions assigned to this group
1A
Sexual partners of members of Group 1
No interventions assigned to this group
2
Established HIV-infection
No interventions assigned to this group
3
HIV-1 uninfected
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Willing to provide updated locator information during the study
* Acute HIV infection OR sexual partner of a Group 1 participant with acute HIV infection
* Established HIV infection (positive HIV antibody test and positive HIV Western blot)
* HIV uninfected
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Myron S. Cohen, MD
Role: STUDY_CHAIR
Medicine, Microbiology, and Immunology and Public Health, Division of Infectious Diseases, University of North Carolina Center for Infectious Diseases
Locations
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UNC School of Medicine, Div. of Infectious Diseases CHAVI CRS
Chapel Hill, North Carolina, United States
Duke Univ. Med. Ctr., Infectious Diseases Clinic CHAVI CRS
Durham, North Carolina, United States
Queen Elizabeth Hosp., Malawi College of Medicine-Johns Hopkins Research Project CHAVI CRS
Blantyre, , Malawi
Kamuzu Central Hosp. CHAVI CRS
Lilongwe, , Malawi
Univ. of Witwatersrand, Chris Hani Baragwanath Hosp., Reproductive Health Research Unit CHAVI CRS
Johannesburg, Gauteng, South Africa
CAPRISA eThekwini CHAVI CRS
Durban, KwaZulu-Natal, South Africa
Aurum Institute for Health Research CHAVI CRS
Klerksdorp, , South Africa
Kilimanjaro Christian Med. Ctr. CHAVI CRS
Moshi, , Tanzania
Uganda Virus Research Institute, MRC/UVRI Uganda Research Unit on AIDS CHAVI CRS
Entebbe, , Uganda
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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CHAVI 001
Identifier Type: -
Identifier Source: org_study_id