Resistance to HIV Infection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00069485
First received: September 26, 2003
Last updated: September 17, 2007
Last verified: July 2007
  Purpose

The immune systems of some individuals may be capable of resisting HIV infection. These individuals do not appear to be infected with HIV despite multiple sexual encounters with HIV infected partners. This study will examine the immune systems of these individuals to determine what factors are responsible for their ability to resist HIV infection.

Study hypothesis: Some long-term, multiply-exposed seronegative persons have relative resistance to HIV infection maintained by T cell responses.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Evaluation of HIV-Specific Immunological and Virological Responses of HIV-1 Multiply-Exposed Seronegative Individuals

Resource links provided by NLM:


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

Estimated Enrollment: 100
Study Start Date: December 1995
Detailed Description:

Rare individuals appear naturally resistant to overt HIV-1 infection despite repeated sexual exposures. These individuals, referred to as exposed seronegatives (ES), represent a unique population in which to evaluate mechanisms by which HIV-1 replication is either controlled or aborted. The purpose of the study is to analyze HIV-specific immune responses, both cellular and humoral, that exist in seronegative individuals who have experienced multiple exposures to HIV by sexual contact.

This study will follow participants for 2 years. Participants will have 25 study visits during the study. Assessments will include HIV tests, viral load measurements, CD4 counts, pregnancy tests, and physical exams.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general health
  • HIV uninfected
  • Repeated exposures to HIV through unprotected sexual intercourse within the 2 years prior to study entry
  • Live in the greater Seattle area
  • Plan to stay in the greater Seattle area for the 2 years after study entry

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069485

Locations
United States, Washington
Fred Hutchinson Cancer Research Center / University of Washington HIV Vaccine Trials Unit Recruiting
Seattle, Washington, United States, 98104
Contact: Kim Louis    206-667-2300    klouis@fhcrc.org   
Sponsors and Collaborators
Investigators
Principal Investigator: Julie McElrath, MD, PhD University of Washington
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00069485     History of Changes
Other Study ID Numbers: 5R01AI47086-03, 5 R01 AI47086-03
Study First Received: September 26, 2003
Last Updated: September 17, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Seronegativity

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on April 14, 2014