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
  Purpose

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
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute HIV-1 Infection Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1300
Study Start Date: June 2006
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Proven acute HIV-1 infection
1A
Sexual partners of members of Group 1
2
Established HIV-infection
3
HIV-1 uninfected

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296660

Locations
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
Malawi
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
CAPRISA eThekwini CHAVI CRS
Durban, KwaZulu-Natal, South Africa, 4001
Aurum Institute for Health Research CHAVI CRS
Klerksdorp, South Africa, 2571
Tanzania
Kilimanjaro Christian Med. Ctr. CHAVI CRS
Moshi, Tanzania
Uganda
Uganda Virus Research Institute, MRC/UVRI Uganda Research Unit on AIDS CHAVI CRS
Entebbe, Uganda
Sponsors and Collaborators
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00296660     History of Changes
Other Study ID Numbers: CHAVI 001
Study First Received: February 24, 2006
Last Updated: November 18, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 29, 2014