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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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

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: 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

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:


Acquired Immunodeficiency Syndrome HIV Infections Infection Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections	RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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