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Collection of Blood Samples From SMART Study Participants for Future Genetic Studies

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ClinicalTrials.gov Identifier: NCT00377169
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : November 1, 2016
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to collect blood samples from SMART study participants to use in future genetic studies.

Condition or disease
HIV Infections

Detailed Description:

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.

Study Design

Study Type : Observational
Estimated Enrollment : 3261 participants
Official Title: Genomics: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
Primary Completion Date : January 2006
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Coenrollment in the SMART study
  • Parent or guardian willing to provide informed consent, if applicable
Contacts and Locations

Information from the National Library of Medicine

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): NCT00377169

  Show 42 Study Locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Community Programs for Clinical Research on AIDS
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
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00377169     History of Changes
Other Study ID Numbers: CPCRA 065H
First Posted: September 15, 2006    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: September 2006

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases