HIVNCT01336855
Collection of Blood for Multiple Collaborative Studies
An observational study of HIV, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study seeks to confidentially collect blood from HIV-positive individuals and HIV-negative controls to provide basic scientists with specimens for collaborative studies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1988to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: 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.
Read the 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
- Conditions
- HIV
- Keywords
- HIV, Observational, Pathogenesis, Immunology, Virology, Control, Healthy control, Men who have sex with men
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV Positive | HIV-1 positive subjects | |
| HIV negative subjects | HIV-1 seronegative control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma HIV RNA level
Viral load
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startJan 1988
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Deeks, M.D., Principal investigator, University of Californa, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336855
- Sponsor's protocol ID
- H8211-04743-22
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2011
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection and Preservation of Blood and Serum Specimens From HIV Positive or HIV Negative Patients for Multiple Collaborative Studies
- ClinicalTrials.gov ID
- NCT01336855
- Acronym / sponsor ID
- H8211-04743-22
- Conditions
- HIV
- Keywords
- HIV, Observational, Pathogenesis, Immunology, Virology, Control, Healthy control, Men who have sex with men
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 1988
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to confidentially collect blood from HIV-positive individuals and HIV-negative controls to provide basic scientists with specimens for collaborative studies.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV Positive | – | –HIV-1 positive subjects |
| HIV negative subjects | – | –HIV-1 seronegative control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma HIV RNA level
Time frame: Ongoing
Viral load
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Deeks, M.D. principal investigator
University of Californa, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Hoh, M.S., R.D. (415-476-4082 ext. 139, Rebecca.Hoh@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma HIV RNA level (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.