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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001121 |
The purpose of this study is to evaluate the long-term consequences of HIV-1 infections that occurred in association with known, but discouraged, high-risk behaviors in persons who have received HIV candidate vaccines or placebo in HIVNET 014. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS.
Patients who receive HIV vaccines are sometimes protected from HIV infection. More often, these patients become HIV-positive but experience a boost in their immune system that helps their bodies fight HIV. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS.
Condition |
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HIV Infections |
Study Type: | Observational |
Official Title: | Evaluation of Virologic, Immunologic, and Clinical Parameters of Participants in HIVNET 014 Who Become Infected With HIV-1 |
Study Start Date: | August 1999 |
There are many possible outcomes of HIV-1 infection among persons who receive experimental HIV-1 vaccines. In the best-case scenario, these vaccines may prevent infection (sterilizing immunity). However, current viral vaccines are thought to limit, but not prevent, virus replication after infection. In the latter case, it is important to document the effect of the immune response on the disease course as reflected by viral load, the evolution of the viral quasi species, and clinical symptoms over time. Understanding the evolution of the immune response in vaccinees after subsequent exposure and HIV infection will potentially result in valuable information for the subsequent design of preventive and therapeutic vaccines. This will be studied here using HIVNET 014 participants at higher risk for HIV-1 infection.
Participants discontinue HIVNET 014 vaccinations upon confirmation of HIV-1 infection and are enrolled in this study. Participants undergo clinical and laboratory examinations every 3 months for the first year of follow-up and every 6 months for at least 4 years thereafter. Additionally, HIV-infected partners of HIVNET 014A participants undergo clinical and laboratory examination at enrollment, and may be asked to donate additional specimens at a later time. Study endpoints include various virologic, immunologic, and clinical parameters, such as viral load, cellular immune response, and virus phenotype and genotype.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, California | |
San Francisco Dept of Hlth / AIDS Office | |
San Francisco, California, United States, 94102 | |
United States, Colorado | |
Denver Dept of Public Health / HIVNET | |
Denver, Colorado, United States, 80204 | |
United States, Illinois | |
Univ of Illinois Chicago / Howard Brown Hlth Ctr | |
Chicago, Illinois, United States, 60612 | |
Howard Brown Health Ctr / HIVNET | |
Chicago, Illinois, United States, 60657 | |
United States, Massachusetts | |
Fenway Community Health Ctr / HIVNET | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
New York Blood Ctr | |
Bronx, New York, United States, 10456 | |
United States, Pennsylvania | |
Univ of Pennsylvania / HIVNET | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Rhode Island | |
Mem Hosp of Rhode Island | |
Pawtucket, Rhode Island, United States, 02860 | |
Miriam Hosp | |
Providence, Rhode Island, United States, 02906 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 98104 |
Study Chair: | Connie Celum | |
Study Chair: | Susan Buchbinder | |
Study Chair: | Haynes Sheppard |
Study ID Numbers: | HIVNET 014A |
Study First Received: | November 2, 1999 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00001121 |
Health Authority: | United States: Federal Government |
Placebos AIDS Vaccines Follow-Up Studies HIV Therapeutic Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |