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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00377169
First Posted: September 15, 2006
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Community Programs for Clinical Research on AIDS
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
The purpose of this study is to collect blood samples from SMART study participants to use in future genetic studies.

Condition
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)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 3261
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Investigators
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
SMART
First Submitted: September 14, 2006
First Posted: September 15, 2006
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


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