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Resistance to HIV Infection

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ClinicalTrials.gov Identifier: NCT00069485
Recruitment Status : Unknown
Verified July 2007 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was:  Recruiting
First Posted : September 30, 2003
Last Update Posted : September 18, 2007
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief Summary:

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 or disease
HIV Infections

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.


Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Evaluation of HIV-Specific Immunological and Virological Responses of HIV-1 Multiply-Exposed Seronegative Individuals
Study Start Date : December 1995

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): 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
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Julie McElrath, MD, PhD University of Washington
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00069485     History of Changes
Other Study ID Numbers: 5R01AI047086-03 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2003    Key Record Dates
Last Update Posted: September 18, 2007
Last Verified: July 2007

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

Additional relevant MeSH terms:
Infection
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