SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era
This study is currently recruiting participants.
(see Contacts and Locations)
Verified October 2014 by University of California, San Francisco
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00187512
First received: September 13, 2005
Last updated: October 28, 2014
Last verified: October 2014
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Purpose
SCOPE is an observational, prospective study of HIV-1 infected volunteers designed to provide a specimen bank of samples with carefully characterized clinical data. SCOPE specimens will be used to examine multiple questions involving virologic, immunologic, and host factors involved in HIV-1 infection, progression, non-progression, response to treatment, control of HIV-1 virus, and evolution of drug resistance.
| Condition |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era |
Resource links provided by NLM:
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Proteinase inhibitor
U.S. FDA Resources
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- The general theme of this core is to investigate the relationship between the virologic response to antiretroviral therapy and clinical outcome. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Plasma, serum, PMBCs, saliva
| Estimated Enrollment: | 2000 |
| Study Start Date: | March 2000 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
SCOPE is an observational, prospective study of HIV-1 infected volunteers designed to provide a specimen bank of samples with carefully characterized clinical data. Samples from SCOPE will be used to examine:
- Virologic, immunologic, and host factors involved in the natural control of HIV-1 infection (long term non-progression and/or virologic control of HIV-1 without antiretroviral therapy)
- Virologic and immune correlates associated with disease progression
- Evolution of antiretroviral drug resistance
- Factors associated with transmission or acquisition of HIV infection
Enrolled subjects are seen at San Francisco General Hospital every four months for a detailed interview, saliva collection, and blood draw. Baseline visits take approximately one hour, follow up visits take approximately 20-40 minutes. No personal identifiers are used for specimen bank samples.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
The study is open to eligible subjects who are able to perform study visits at San Francisco General Hospital or the San Francisco VA Medical Center.
Criteria
Inclusion Criteria:
SCOPE is currently recruiting HIV-1 infected subjects with any of the following criteria:
- Documented HIV viral load less than 2000 copies/ml WITHOUT taking antiretroviral therapy
- Undetectable HIV viral load with CD4 T-cells consistently less than 350 for the last 12 months while taking a stable antiretroviral regimen.
- Antiretroviral naive and planning to start an antiretroviral regimen - any CD4 or HIV viral load acceptable.
- Long-term Non Progressors: HIV-positive at least 10 years, no antiretroviral therapy for the past 10 years or more, any viral load acceptable, CD4-T cell count always above 500.
Exclusion Criteria:
- Active opportunistic infection or systemic treatment for opportunistic infection within the last 4 months (oral candidiasis acceptable)
- Active treatment for cancer
- Active treatment for hepatitis C requiring interferon based therapy
- Immunosuppressive therapy taken 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: NCT00187512
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187512
Contacts
| Contact: Rebecca Hoh, M.S., R.D. | 415-476-4082 ext 139 | rhoh@php.ucsf.edu | |
| Contact: Joy Madamba, B.S. | 415-476-4082 ext 155 | jmadamba@php.ucsf.edu |
Locations
| United States, California | |
| San Francisco General Hospital | Recruiting |
| San Francisco, California, United States, 94110 | |
| Contact: Rebecca Hoh, M.S. 415-476-4082 ext 139 rhoh@php.ucsf.edu | |
| Contact: Joy Madamba, B.S. 415-476-4082 ext 155 jmadamba@php.ucsf.edu | |
| Principal Investigator: Steven G. Deeks, M.D. | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Steven G. Deeks, M.D. | University of California, San Francisco |
More Information
Additional Information:
No publications provided by University of California, San Francisco
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00187512 History of Changes |
| Other Study ID Numbers: | 10-01330 |
| Study First Received: | September 13, 2005 |
| Last Updated: | October 28, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
HIV Antiretroviral Agents Drug Resistance, Multiple Long Term Non Progression Long Term Non Progressor |
Elite Suppression Elite Suppressor Natural History Observational |
Additional relevant MeSH terms:
|
HIV Protease Inhibitors Protease Inhibitors Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents |
Antiviral Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015