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

October 31, 2016 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Anticipated)

3261

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • American Samoa
      • Highgate Hill, American Samoa, 4101
        • Gladstone Road Medical Centre
  • Australia
      • Perth, Australia
        • Royal Perth Hospital
      • Westmead, Australia
        • Westmead Hospital
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Royal Melbourne Hospital
  • Belgium
      • Bruxelles, Belgium, 1000
        • C.H.U. St. Pierre Center Hospitalier Universitaire
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2L49P
        • Clinique médicale l'Actuel
  • Chile
      • Santiago, Chile
        • Fundacion Arriaran Santa Elvira
  • Denmark
      • Brendstrupgaardvej Aarhus, Denmark, DK-8200
        • Arbus Universitetshospital, Skejby Department of Infectious Diseases
  • Finland
      • Helsinki, Finland, 00029 FI
        • Helsinki University Central Hospital
  • Gambia
      • Bonn, Gambia, 53105
        • Medizinische Universitätsklinik
      • Heidelberg, Gambia, D-69115
        • Klinikum der Ruprecht-Karis-Universitat (U. Hospit)
  • Germany
      • Frankfurt, Germany
        • J.W. Goethe University Hospital
      • Hamburg, Germany, D-20099
        • ifi Institut
      • Koln, Germany
        • University Hospital Koln (Cologne)
      • Munich, Germany
        • Infektionsambulanz und Tagesklinik Poliklinik Innenstadt der
  • Japan
      • Tokyo, Japan, 162-8655
        • AIDS Medical Center, International Medical Center
  • Morocco
      • Casablanca, Morocco, 20100 MA
        • University Hospital Center Ibn Rochd
  • New Zealand
      • Christchurch, New Zealand
        • Christchurch Hospital
      • Hamilton, New Zealand
        • Waikato Hospital
    • Wellington
      • New Town, Wellington, New Zealand
        • Wellington Hospital
  • Poland
      • Koszarowa, Poland
        • Wroclaw University School of Medicine
  • Portugal
      • Cascais, Portugal, 2750-406 PT
        • Centro Hospital de Cascais
      • Lisbon, Portugal, 1649-028 PT
        • Hospital de Santa Maria
      • Porto, Portugal, 4369-004 PT
        • Hospital Joaquim Urbano
  • United States
    • California
      • Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System
      • Los Angeles, California, United States, 90022
        • AltaMed Health Services Corporation
      • Los Angeles, California, United States, 90028
        • Los Angeles Gay & Lesbian Community Service Center
      • Los Angeles, California, United States, 90073
        • VA Greater Loss Angeles Healthcare System
    • Florida
      • Ft. Lauderdale, Florida, United States, 33311
        • Comprehensive Care Center/North Broward Hospital
      • Tampa, Florida, United States, 33602
        • Hillsborough County Health Department
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Absolute Care Clinic
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta (ARCA) Central
      • Atlanta, Georgia, United States, 30308
        • Dr. Dennis Melton (private practice)
      • Atlanta, Georgia, United States, 30308
        • Dr. Melanie Thompson and Dr. Annette Bernard (private practice)
      • Atlanta, Georgia, United States, 30308
        • Dr. Richard Hudson (private practice)
      • Atlanta, Georgia, United States, 30308
        • AID Atlanta/Morehouse Medical School Ryan White Cl
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic/CORNET
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center/New York Medical College
    • Texas
      • Fort Worth, Texas, United States, 76104
        • University of North Texas Health Science Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert and Medical College I.D. Clinic
  • Uruguay
      • Montevideo, Uruguay, 11600
        • Catedra de Enfermedades Infecciosas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

September 14, 2006

First Submitted That Met QC Criteria

September 14, 2006

First Posted (Estimate)

September 15, 2006

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPCRA 065H
  • SMART

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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