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
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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.
Condition or disease |
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HIV Infections |
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 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 |


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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
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 |
Principal Investigator: | Julie McElrath, MD, PhD | University of Washington |
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 |