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

Primary Purpose

HIV Infections

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring Treatment Experienced

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • AltaMed Health Services Corporation
  • Los Angeles Gay & Lesbian Community Service Center
  • VA Greater Los Angeles Healthcare System
  • VA Greater Loss Angeles Healthcare System
  • Comprehensive Care Center/North Broward Hospital
  • Hillsborough County Health Department
  • Absolute Care Clinic
  • AID Atlanta/Morehouse Medical School Ryan White Cl
  • AIDS Research Consortium of Atlanta (ARCA) Central
  • Dr. Dennis Melton (private practice)
  • Dr. Melanie Thompson and Dr. Annette Bernard (private practice)
  • Dr. Richard Hudson (private practice)
  • Mayo Clinic/CORNET
  • SUNY Downstate Medical Center
  • Westchester Medical Center/New York Medical College
  • University of North Texas Health Science Center
  • Froedtert and Medical College I.D. Clinic
  • Gladstone Road Medical Centre
  • Royal Melbourne Hospital
  • Royal Perth Hospital
  • Westmead Hospital
  • C.H.U. St. Pierre Center Hospitalier Universitaire
  • Clinique Medicale L'actuel
  • Fundacion Arriaran Santa Elvira
  • Arbus Universitetshospital, Skejby Department of Infectious Diseases
  • Helsinki University Central Hospital
  • Medizinische Universitatsklinik
  • Klinikum der Ruprecht-Karis-Universitat (U. Hospit)
  • J.W. Goethe University Hospital
  • ifi Institut
  • University Hospital Koln (Cologne)
  • Infektionsambulanz und Tagesklinik Poliklinik Innenstadt der
  • AIDS Medical Center, International Medical Center
  • University Hospital Center Ibn Rochd
  • Wellington Hospital
  • Christchurch Hospital
  • Waikato Hospital
  • Wroclaw University School of Medicine
  • Centro Hospital de Cascais
  • Hospital de Santa Maria
  • Hospital Joaquim Urbano
  • Catedra de Enfermedades Infecciosas

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 14, 2006
Last Updated
October 31, 2016
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Community Programs for Clinical Research on AIDS
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1. Study Identification

Unique Protocol Identification Number
NCT00377169
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)
Study Type
Observational

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Community Programs for Clinical Research on AIDS

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Treatment Experienced

7. Study Design

Enrollment
3261 (Anticipated)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Coenrollment in the SMART study Parent or guardian willing to provide informed consent, if applicable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Uy, MD
Organizational Affiliation
AIDS Research Alliance Chicago (ARAC), University of Illinois at Chicago
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Roberto Arduino, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fraser Drummond, MBChB, MRCA, DA (UK)
Organizational Affiliation
National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Daniela Gey, MD
Organizational Affiliation
Copenhagen HIV Programme, Hvidovre University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Adrian Palfreeman, MD
Organizational Affiliation
Peterborough and Stamford Hospitals NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
AltaMed Health Services Corporation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Los Angeles Gay & Lesbian Community Service Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
VA Greater Loss Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Comprehensive Care Center/North Broward Hospital
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Hillsborough County Health Department
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Absolute Care Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
AID Atlanta/Morehouse Medical School Ryan White Cl
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
AIDS Research Consortium of Atlanta (ARCA) Central
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Dr. Dennis Melton (private practice)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Dr. Melanie Thompson and Dr. Annette Bernard (private practice)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Dr. Richard Hudson (private practice)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Mayo Clinic/CORNET
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Westchester Medical Center/New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
University of North Texas Health Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Froedtert and Medical College I.D. Clinic
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Gladstone Road Medical Centre
City
Highgate Hill
ZIP/Postal Code
4101
Country
American Samoa
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
Country
Australia
Facility Name
C.H.U. St. Pierre Center Hospitalier Universitaire
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Clinique Medicale L'actuel
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L49P
Country
Canada
Facility Name
Fundacion Arriaran Santa Elvira
City
Santiago
Country
Chile
Facility Name
Arbus Universitetshospital, Skejby Department of Infectious Diseases
City
Brendstrupgaardvej Aarhus
ZIP/Postal Code
DK-8200
Country
Denmark
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029 FI
Country
Finland
Facility Name
Medizinische Universitatsklinik
City
Bonn
ZIP/Postal Code
53105
Country
Gambia
Facility Name
Klinikum der Ruprecht-Karis-Universitat (U. Hospit)
City
Heidelberg
ZIP/Postal Code
D-69115
Country
Gambia
Facility Name
J.W. Goethe University Hospital
City
Frankfurt
Country
Germany
Facility Name
ifi Institut
City
Hamburg
ZIP/Postal Code
D-20099
Country
Germany
Facility Name
University Hospital Koln (Cologne)
City
Koln
Country
Germany
Facility Name
Infektionsambulanz und Tagesklinik Poliklinik Innenstadt der
City
Munich
Country
Germany
Facility Name
AIDS Medical Center, International Medical Center
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
University Hospital Center Ibn Rochd
City
Casablanca
ZIP/Postal Code
20100 MA
Country
Morocco
Facility Name
Wellington Hospital
City
New Town
State/Province
Wellington
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand
Facility Name
Wroclaw University School of Medicine
City
Koszarowa
Country
Poland
Facility Name
Centro Hospital de Cascais
City
Cascais
ZIP/Postal Code
2750-406 PT
Country
Portugal
Facility Name
Hospital de Santa Maria
City
Lisbon
ZIP/Postal Code
1649-028 PT
Country
Portugal
Facility Name
Hospital Joaquim Urbano
City
Porto
ZIP/Postal Code
4369-004 PT
Country
Portugal
Facility Name
Catedra de Enfermedades Infecciosas
City
Montevideo
ZIP/Postal Code
11600
Country
Uruguay

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.gov/show/NCT00027352
Description
Click here for more information on CPCRA 065

Learn more about this trial

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

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