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Resistance to HIV Infection

NCT ID: NCT00069485

Last Updated: 2007-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

1995-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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HIV Seronegativity

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Principal Investigators

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Julie McElrath, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Fred Hutchinson Cancer Research Center / University of Washington HIV Vaccine Trials Unit

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Kim Louis

Role: primary

Other Identifiers

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5R01AI047086-03

Identifier Type: NIH

Identifier Source: secondary_id

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5R01AI047086-03

Identifier Type: NIH

Identifier Source: org_study_id

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