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

This study has been completed.
Sponsor:
Collaborator:
Community Programs for Clinical Research on AIDS
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00377169
First received: September 14, 2006
Last updated: October 31, 2016
Last verified: September 2006

September 14, 2006
October 31, 2016
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January 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00377169 on ClinicalTrials.gov Archive Site
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Collection of Blood Samples From SMART Study Participants for Future Genetic Studies
Genomics: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
The purpose of this study is to collect blood samples from SMART study participants to use in future genetic studies.

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.

Observational
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HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3261
January 2006
January 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Coenrollment in the SMART study
  • Parent or guardian willing to provide informed consent, if applicable
Both
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   American Samoa,   Australia,   Belgium,   Canada,   Chile,   Denmark,   Finland,   Gambia,   Germany,   Japan,   Morocco,   New Zealand,   Poland,   Portugal,   Uruguay
 
NCT00377169
CPCRA 065H, SMART
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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
National Institute of Allergy and Infectious Diseases (NIAID)
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP