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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Community Programs for Clinical Research on AIDS |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00377169 |
The purpose of this study is to collect blood samples from SMART study participants to use in future genetic studies.
Condition |
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HIV Infections |
Study Type: | Observational |
Official Title: | Genomics: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study) |
Estimated Enrollment: | 3261 |
Despite progress in the treatment of HIV and a greater understanding of the pathophysiology of HIV infection, there are still unexplained differences in both the progression of untreated HIV infection and response to antiretroviral therapy. These differences are likely related to the unique genetic makeup of individuals with HIV infection. Particular genes may offer protection against HIV infection, while other genes may make disease progression more likely. Knowing more about the genetic makeup of HIV infected individuals may lead to the development of a targeted treatment strategy based on an individual's specific risk of disease progression and sensitivity to medication toxicity. The purpose of this substudy is to collect blood samples from SMART study participants. The samples will be used in future Community Programs for Clinical Research on AIDS (CPCRA) studies investigating the link between human genetic factors and clinical outcome data.
This study will enroll individuals currently participating in the SMART study. Participants will provide one blood sample. Individual test results from future blood analyses will not be provided to a patient unless they may have profound health implications for that patient.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study Chair: | Jonathan Uy, MD | AIDS Research Alliance Chicago (ARAC), University of Illinois at Chicago |
Study Chair: | Roberto Arduino, MD | The University of Texas Health Science Center, Houston |
Study Chair: | Fraser Drummond, MBChB, MRCA, DA (UK) | National Centre in HIV Epidemiology and Clinical Research, University of New South Wales |
Study Chair: | Daniela Gey, MD | Copenhagen HIV Programme, Hvidovre University Hospital |
Study Chair: | Adrian Palfreeman, MD | Peterborough and Stamford Hospitals NHS Foundation Trust |
Study ID Numbers: | CPCRA 065H, SMART |
Study First Received: | September 14, 2006 |
Last Updated: | November 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00377169 |
Health Authority: | United States: Federal Government |
Treatment Experienced |
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 |