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Acute HIV Infection Observational Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00296660
First received: February 24, 2006
Last updated: November 18, 2013
Last verified: November 2013

February 24, 2006
November 18, 2013
June 2006
June 2013   (final data collection date for primary outcome measure)
  • Prevalence of acute HIV infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Characteristics of transmitted virus in acute HIV infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Immune responses contributing to viral control and/or protection against HIV infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Genetic factors contributing to early virus control and/or protection from HIV infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00296660 on ClinicalTrials.gov Archive Site
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Acute HIV Infection Observational Study
Acute HIV-1 Infection Prospective Cohort Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

HIV Infections
Not Provided
  • 1
    Proven acute HIV-1 infection
  • 1A
    Sexual partners of members of Group 1
  • 2
    Established HIV-infection
  • 3
    HIV-1 uninfected

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1300
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Malawi,   South Africa,   Tanzania,   Uganda
 
NCT00296660
CHAVI 001
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
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
National Institute of Allergy and Infectious Diseases (NIAID)
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP