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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Active, not recruiting
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: November 9, 2007
Last verified: September 2006
  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
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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377169

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00377169     History of Changes
Other Study ID Numbers: CPCRA 065H, SMART
Study First Received: September 14, 2006
Last Updated: November 9, 2007
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on July 31, 2014