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Collection of Blood for Multiple Collaborative Studies

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01336855
First received: April 14, 2011
Last updated: October 28, 2014
Last verified: October 2014

April 14, 2011
October 28, 2014
January 1988
January 2015   (final data collection date for primary outcome measure)
All subjects will be asked detailed questions about their current health status and current sexual and drug use behavior. HIV positive subjects will additionally be asked specific to HIV-related conditions and treatment. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01336855 on ClinicalTrials.gov Archive Site
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Collection of Blood for Multiple Collaborative Studies
Collection and Preservation of Blood and Serum Specimens From HIV Positive or HIV Negative Patients for Multiple Collaborative Studies

This study seeks to confidentially collect blood from HIV-positive individuals and HIV-negative controls to provide basic scientists with specimens for collaborative studies.

HIV positive patients are currently the focus of multiple collaborative research studies, both at UCSF and other institutions. The aims of these research projects include improving the understanding of etiology, immunology, epidemiology and treatment of HIV. There are numerous requests from basic scientists at UCSF for collaborative studies on specimens, especially for blood, saliva and urine samples. Specimens may be used to test such things as virus characteristics, genotyping and/or phenotyping resistance, plasma drug concentrations, immune function or evidence of complications of HIV disease. The samples may also be tested for genetic factors that may be related to the course of HIV disease

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Plasma, PBMCs, buffy coat, serum, saliva, urine

Non-Probability Sample

Subjects will be selected based on positive or negative HIV antibody, depending on the study for which blood is being collected. Patients will be chosen from the Positive Health Practice populations at SFGH and UCSF, the General Medicine Clinic at the San Francisco Veterans Affairs Medical Center. HIV uninfected healthy volunteers with comparable risk factors to the HIV positive subjects will be recruited from the community.

HIV
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  • HIV Positive
    HIV-1 positive subjects
  • HIV negative subjects
    HIV-1 seronegative control group
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-1 antibody negative with similar characteristics to HIV-1 positive cohort
  • HIV-positive subjects naive to antiretroviral therapy
  • HIV-positive subjects stable on or off antiretroviral therapy for a minimum of 6 months
  • Good venous access
  • Able to provide informed consent

Exclusion Criteria:

  • Hemoglobin < 9g/dl
  • Hematocrit < 27%
  • Active treatment for cancer
  • Hospitalization or IV antibiotic use within the last 4 months
  • Immunosuppressive therapy within the last 4 months
Both
18 Years and older
Yes
Contact: Rebecca Hoh, M.S., R.D. 415-476-4082 ext 139 rhoh@php.ucsf.edu
United States
 
NCT01336855
H8211-04743-22
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Steven Deeks, M.D. University of Californa, San Francisco
University of California, San Francisco
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP