Collection of Blood for Multiple Collaborative Studies
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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 |
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 |
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.
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| Contact: Rebecca Hoh, M.S., R.D. | 415-476-4082 ext 139 | rhoh@php.ucsf.edu |
| United States, California | |
| San Francisco General Hospital | Recruiting |
| San Francisco, California, United States, 94110 | |
| 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: | November 8, 2012 |
| 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 May 16, 2013