Clinical trial NCT00377169: 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
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Treatment Experienced
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Community Programs for Clinical Research on AIDS
First posted: 2006-09-15
Enrollment: 3261
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AltaMed Health Services Corporation
state: California
city: Los Angeles
country: United States
facility: Los Angeles Gay & Lesbian Community Service Center
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Los Angeles
country: United States
facility: VA Greater Loss Angeles Healthcare System
state: California
city: Ft. Lauderdale
country: United States
facility: Comprehensive Care Center/North Broward Hospital
state: Florida
city: Tampa
country: United States
facility: Hillsborough County Health Department
state: Florida
city: Atlanta
country: United States
facility: Absolute Care Clinic
state: Georgia
city: Atlanta
country: United States
facility: AID Atlanta/Morehouse Medical School Ryan White Cl
state: Georgia
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta (ARCA) Central
state: Georgia
city: Atlanta
country: United States
facility: Dr. Dennis Melton (private practice)
state: Georgia
city: Atlanta
country: United States
facility: Dr. Melanie Thompson and Dr. Annette Bernard (private practice)
state: Georgia
city: Atlanta
country: United States
facility: Dr. Richard Hudson (private practice)
state: Georgia
city: Rochester
country: United States
facility: Mayo Clinic/CORNET
state: Minnesota
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center/New York Medical College
state: New York
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center
state: Texas
city: Milwaukee
country: United States
facility: Froedtert and Medical College I.D. Clinic
state: Wisconsin
city: Highgate Hill
country: American Samoa
facility: Gladstone Road Medical Centre
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Westmead
country: Australia
facility: Westmead Hospital
city: Bruxelles
country: Belgium
facility: C.H.U. St. Pierre Center Hospitalier Universitaire
city: Montreal
country: Canada
facility: Clinique Medicale L'actuel
state: Quebec
city: Santiago
country: Chile
facility: Fundacion Arriaran Santa Elvira
city: Brendstrupgaardvej Aarhus
country: Denmark
facility: Arbus Universitetshospital, Skejby Department of Infectious Diseases
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Bonn
country: Gambia
facility: Medizinische Universitatsklinik
city: Heidelberg
country: Gambia
facility: Klinikum der Ruprecht-Karis-Universitat (U. Hospit)
city: Frankfurt
country: Germany
facility: J.W. Goethe University Hospital
city: Hamburg
country: Germany
facility: ifi Institut
city: Koln
country: Germany
facility: University Hospital Koln (Cologne)
city: Munich
country: Germany
facility: Infektionsambulanz und Tagesklinik Poliklinik Innenstadt der
city: Tokyo
country: Japan
facility: AIDS Medical Center, International Medical Center
city: Casablanca
country: Morocco
facility: University Hospital Center Ibn Rochd
city: New Town
country: New Zealand
facility: Wellington Hospital
state: Wellington
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Koszarowa
country: Poland
facility: Wroclaw University School of Medicine
city: Cascais
country: Portugal
facility: Centro Hospital de Cascais
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria
city: Porto
country: Portugal
facility: Hospital Joaquim Urbano
city: Montevideo
country: Uruguay
facility: Catedra de Enfermedades Infecciosas
Study officials:
affiliation: AIDS Research Alliance Chicago (ARAC), University of Illinois at Chicago
name: Jonathan Uy, MD
role: STUDY_CHAIR
affiliation: The University of Texas Health Science Center, Houston
name: Roberto Arduino, MD
role: STUDY_CHAIR
affiliation: National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
name: Fraser Drummond, MBChB, MRCA, DA (UK)
role: STUDY_CHAIR
affiliation: Copenhagen HIV Programme, Hvidovre University Hospital
name: Daniela Gey, MD
role: STUDY_CHAIR
affiliation: Peterborough and Stamford Hospitals NHS Foundation Trust
name: Adrian Palfreeman, MD
role: STUDY_CHAIR
References: