Collection of Blood for Multiple Collaborative Studies

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 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: January 7, 2014
Last verified: January 2014
  Purpose

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


Condition
HIV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection and Preservation of Blood and Serum Specimens From HIV Positive or HIV Negative Patients for Multiple Collaborative Studies

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 2000
Study Start Date: January 1988
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV Positive
HIV-1 positive subjects
HIV negative subjects
HIV-1 seronegative control group

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336855

Contacts
Contact: Rebecca Hoh, M.S., R.D. 415-476-4082 ext 139 rhoh@php.ucsf.edu

Locations
United States, California
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Steven Deeks, M.D. University of Californa, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01336855     History of Changes
Other Study ID Numbers: H8211-04743-22
Study First Received: April 14, 2011
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
HIV
Observational
Pathogenesis
Immunology
Virology
Control
Healthy control
Men who have sex with men

ClinicalTrials.gov processed this record on September 15, 2014