Studies of HIV-1 Infection in Newly Infected Individuals in Southern Africa

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00006298
First received: September 26, 2000
Last updated: September 24, 2008
Last verified: July 2004
  Purpose

The main goal of this study is to find out how the immune system responds to a specific type of HIV infection, known as C HIV-1, in order to develop a vaccine against this type of infection. The study involves Southern African populations.

The HIV-1 virus changes rapidly and many different subtypes have been found. In South Africa, limited data have suggested Subtype C HIV-1 is the most common. This study strives to verify the most common subtype and also look at genetic differences and immune responses among newly infected individuals. Results will aid in the development of vaccines specific for certain geographical areas.


Condition
HIV Infections
HIV Seronegativity

Study Type: Observational
Official Title: Virological and Immunological Studies of HIV-1 Infection in Newly Infected Individuals in Southern Africa

Resource links provided by NLM:


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

Estimated Enrollment: 125
Detailed Description:

HIV-1 evolves rapidly and multiple genetic subtypes have been isolated from a number of geographic locations. There are limited data on the distribution of subtypes in the Southern African HIVNET sites. Data suggest subtype C HIV-1 predominates and this study is designed to substantiate and extend these observations to understand the biological relationship between HIV-1 subtypes, genetic variability, and immune responses. Earlier studies were conducted using individuals who had been seropositive for 3 to 9 years with advanced disease status; this study will test reactivity during the early stage of infection. This will assist in the rational selection of prototypic isolates for inclusion in either a single universal vaccine or vaccines tailored for specific subtypes/geographical regions.

Volunteers are recruited from Malawi, South Africa, Zambia, and Zimbabwe. The earliest possible cases of seroconversion are included. At enrollment, participants are counseled appropriately for their HIV status and demographic information is obtained. Participants are followed quarterly up to 12 months. Epidemiological, clinical, and laboratory data are collected during physical exams and blood draws at each visit. Blood samples are used to assess CD4 counts, plasma viral load, genetic parameters, and individual immune responses. Participants who are seronegative or whose status is unknown are tested for HIV at each visit, with post-test counseling when participants return to the clinic for test results.

In addition to enrolling the HIV-infected and uninfected volunteers, each site contributes a 5-ml blood sample from 50 seronegative individuals for DNA extraction and HLA genotyping.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

Participants may be eligible for this study if they:

  • Are first HIV-negative and later test HIV-positive; or are HIV-positive and have evidence of being HIV-negative within the 8 months prior to first testing HIV-positive; or are HIV-positive with one test and HIV-negative with another test.

Exclusion Criteria

Participants will not be eligible for this study if they:

  • Have a mental disorder that interferes with agreeing to do the study or with participating in the study.
  • Are receiving anti-HIV treatment for more than 4 weeks.
  • Have tuberculosis.
  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: NCT00006298

Locations
United States, North Carolina
Missie Allen
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
Investigators
Study Chair: Haynes Sheppard
Study Chair: Desmond Martin
Study Chair: Clive Gray
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00006298     History of Changes
Other Study ID Numbers: HIVNET 028
Study First Received: September 26, 2000
Last Updated: September 24, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Antibodies
HIV-1
CD4 Lymphocyte Count
T-Lymphocytes, Cytotoxic
Genotype
Species Specificity
Neutralization Tests
Viral Load
Alleles
HLA Antigens
Cross Reactions
Immunodominant Epitopes
Haplotypes

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 23, 2014