Acute HIV Infection Observational Study

NCT00296660 | Completed

• 1 other identifier: CHAVI 001
• Study Type: observational
• Target: 1,300
• Locations: 5 countries
• Sites: 9

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.

Conditions

HIV Infections

Keywords

Acute Infection

Outcome Measures

Primary Outcomes (5)

• 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

• 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

Study Arms (4)

1

Proven acute HIV-1 infection

1A

Sexual partners of members of Group 1

2

Established HIV-infection

3

HIV-1 uninfected

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Willing to receive HIV test results
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (9)

UNC School of Medicine, Div. of Infectious Diseases CHAVI CRS

Chapel Hill, North Carolina, 27599-7005, United States

Location

Duke Univ. Med. Ctr., Infectious Diseases Clinic CHAVI CRS

Durham, North Carolina, 27710, United States

Location

Queen Elizabeth Hosp., Malawi College of Medicine-Johns Hopkins Research Project CHAVI CRS

Blantyre, Malawi

Location

Kamuzu Central Hosp. CHAVI CRS

Lilongwe, Malawi

Location

Univ. of Witwatersrand, Chris Hani Baragwanath Hosp., Reproductive Health Research Unit CHAVI CRS

Johannesburg, Gauteng, 2001, South Africa

Location

CAPRISA eThekwini CHAVI CRS

Durban, KwaZulu-Natal, 4001, South Africa

Location

Aurum Institute for Health Research CHAVI CRS

Klerksdorp, 2571, South Africa

Location

Kilimanjaro Christian Med. Ctr. CHAVI CRS

Moshi, Tanzania

Location

Uganda Virus Research Institute, MRC/UVRI Uganda Research Unit on AIDS CHAVI CRS

Entebbe, Uganda

Location

Related Publications (5)

• 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.

  PMID: 11089621 BACKGROUND

• 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.

  PMID: 15057296 BACKGROUND

• 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.

  PMID: 15872202 BACKGROUND

• 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.

  PMID: 12095386 BACKGROUND

• 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.

  PMID: 16091249 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Myron S. Cohen, MD

  Medicine, Microbiology, and Immunology and Public Health, Division of Infectious Diseases, University of North Carolina Center for Infectious Diseases

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2006
• First Posted: February 27, 2006
• Study Start: June 1, 2006
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

UG (1); ZA (3); TA (1); US (2); MA (2)