Acute HIV Infection Observational Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00296660
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : November 19, 2013
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease
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.

Study Type : Observational
Estimated Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute HIV-1 Infection Prospective Cohort Study
Study Start Date : June 2006
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Proven acute HIV-1 infection
Sexual partners of members of Group 1
Established HIV-infection
HIV-1 uninfected

Primary Outcome Measures :
  1. Prevalence of acute HIV infection [ Time Frame: Throughout study ]
  2. Characteristics of transmitted virus in acute HIV infection [ Time Frame: Throughout study ]
  3. Immune responses contributing to viral control and/or protection against HIV infection [ Time Frame: Throughout study ]
  4. Genetic factors contributing to early virus control and/or protection from HIV infection [ Time Frame: Throughout study ]
  5. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00296660

United States, North Carolina
UNC School of Medicine, Div. of Infectious Diseases CHAVI CRS
Chapel Hill, North Carolina, United States, 27599-7005
Duke Univ. Med. Ctr., Infectious Diseases Clinic CHAVI CRS
Durham, North Carolina, United States, 27710
Queen Elizabeth Hosp., Malawi College of Medicine-Johns Hopkins Research Project CHAVI CRS
Blantyre, Malawi
Kamuzu Central Hosp. CHAVI CRS
Lilongwe, Malawi
South Africa
Univ. of Witwatersrand, Chris Hani Baragwanath Hosp., Reproductive Health Research Unit CHAVI CRS
Johannesburg, Gauteng, South Africa, 2001
Durban, KwaZulu-Natal, South Africa, 4001
Aurum Institute for Health Research CHAVI CRS
Klerksdorp, South Africa, 2571
Kilimanjaro Christian Med. Ctr. CHAVI CRS
Moshi, Tanzania
Uganda Virus Research Institute, MRC/UVRI Uganda Research Unit on AIDS CHAVI CRS
Entebbe, Uganda
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00296660     History of Changes
Other Study ID Numbers: CHAVI 001
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acute Infection

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases