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NCT00377169 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
Genomics: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00377169
Other study ID # CPCRA 065H
Secondary ID SMART
Status Completed
Phase N/A
First received September 14, 2006
Last updated October 31, 2016
Est. completion date January 2006

Study information
Verified date September 2006
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

The purpose of this study is to collect blood samples from SMART study participants to use in future genetic studies.

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.

Recruitment information / eligibility
Status Completed
Enrollment 3261
Est. completion date January 2006
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria:

- Coenrollment in the SMART study

- Parent or guardian willing to provide informed consent, if applicable

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
American Samoa Gladstone Road Medical Centre Highgate Hill
Australia Royal Melbourne Hospital Parkville Victoria
Australia Royal Perth Hospital Perth
Australia Westmead Hospital Westmead
Belgium C.H.U. St. Pierre Center Hospitalier Universitaire Bruxelles
Canada Clinique Medicale L'actuel Montreal Quebec
Chile Fundacion Arriaran Santa Elvira Santiago
Denmark Arbus Universitetshospital, Skejby Department of Infectious Diseases Brendstrupgaardvej Aarhus
Finland Helsinki University Central Hospital Helsinki
Gambia Medizinische Universitatsklinik Bonn
Gambia Klinikum der Ruprecht-Karis-Universitat (U. Hospit) Heidelberg
Germany J.W. Goethe University Hospital Frankfurt
Germany ifi Institut Hamburg
Germany University Hospital Koln (Cologne) Koln
Germany Infektionsambulanz und Tagesklinik Poliklinik Innenstadt der Munich
Japan AIDS Medical Center, International Medical Center Tokyo
Morocco University Hospital Center Ibn Rochd Casablanca
New Zealand Christchurch Hospital Christchurch
New Zealand Waikato Hospital Hamilton
New Zealand Wellington Hospital New Town Wellington
Poland Wroclaw University School of Medicine Koszarowa
Portugal Centro Hospital de Cascais Cascais
Portugal Hospital de Santa Maria Lisbon
Portugal Hospital Joaquim Urbano Porto
United States Absolute Care Clinic Atlanta Georgia
United States AID Atlanta/Morehouse Medical School Ryan White Cl Atlanta Georgia
United States AIDS Research Consortium of Atlanta (ARCA) Central Atlanta Georgia
United States Dr. Dennis Melton (private practice) Atlanta Georgia
United States Dr. Melanie Thompson and Dr. Annette Bernard (private practice) Atlanta Georgia
United States Dr. Richard Hudson (private practice) Atlanta Georgia
United States SUNY Downstate Medical Center Brooklyn New York
United States University of North Texas Health Science Center Fort Worth Texas
United States Comprehensive Care Center/North Broward Hospital Ft. Lauderdale Florida
United States AltaMed Health Services Corporation Los Angeles California
United States Los Angeles Gay & Lesbian Community Service Center Los Angeles California
United States VA Greater Los Angeles Healthcare System Los Angeles California
United States VA Greater Loss Angeles Healthcare System Los Angeles California
United States Froedtert and Medical College I.D. Clinic Milwaukee Wisconsin
United States Mayo Clinic/CORNET Rochester Minnesota
United States Hillsborough County Health Department Tampa Florida
United States Westchester Medical Center/New York Medical College Valhalla New York
Uruguay Catedra de Enfermedades Infecciosas Montevideo

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Community Programs for Clinical Research on AIDS

Countries where clinical trial is conducted

United States,  Uruguay,  American Samoa,  Australia,  Belgium,  Canada,  Chile,  Denmark,  Finland,  Gambia,  Germany,  Japan,  Morocco,  New Zealand,  Poland,  Portugal, 

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