SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era
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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 |
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 |
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.
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| 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 |
| 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. | |
| 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: | March 8, 2012 |
| 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 Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Protease Inhibitors Anti-Retroviral Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013