Collection of Blood for Multiple Collaborative Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01336855
Recruitment Status : Recruiting
First Posted : April 18, 2011
Last Update Posted : October 15, 2018
Information provided by (Responsible Party):
University of California, San Francisco

April 14, 2011
April 18, 2011
October 15, 2018
January 1988
January 2020   (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 ]
Not Provided
Complete list of historical versions of study NCT01336855 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
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 Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
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.
Not Provided
  • HIV Positive
    HIV-1 positive subjects
  • HIV negative subjects
    HIV-1 seronegative control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2020
January 2020   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact: Rebecca Hoh, M.S., R.D. 415-476-4082 ext 139
Contact: Viva Tai, MS. RD 415-476-4082 ext 104
United States
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: 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 2018