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

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.
 
ClinicalTrials.gov Identifier: NCT00377169
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : November 1, 2016
Sponsor:
Collaborator:
Community Programs for Clinical Research on AIDS
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date September 14, 2006
First Posted Date September 15, 2006
Last Update Posted Date November 1, 2016
Study Start Date Not Provided
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collection of Blood Samples From SMART Study Participants for Future Genetic Studies
Official Title Genomics: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
Brief Summary The purpose of this study is to collect blood samples from SMART study participants to use in future genetic studies.
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 Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition HIV Infections
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: September¬†14,¬†2006)
3261
Original Enrollment Same as current
Actual Study Completion Date January 2006
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Coenrollment in the SMART study
  • Parent or guardian willing to provide informed consent, if applicable
Sex/Gender
Sexes Eligible for Study: All
Ages 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries American Samoa,   Australia,   Belgium,   Canada,   Chile,   Denmark,   Finland,   Gambia,   Germany,   Japan,   Morocco,   New Zealand,   Poland,   Portugal,   United States,   Uruguay
Removed Location Countries  
 
Administrative Information
NCT Number NCT00377169
Other Study ID Numbers CPCRA 065H
SMART
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators 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
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date September 2006