View Clinical Trial (Medical Research Study)
SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era
| City: |
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San Francisco |
| State: |
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California |
| Zip Code: |
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94110 |
| Conditions: |
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HIV Infections |
| Purpose: |
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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.
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| Study Summary: |
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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:
1. 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)
2. Virologic and immune correlates associated with disease progression
3. Evolution of antiretroviral drug resistance
4. 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.
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| Criteria: |
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Inclusion Criteria:
SCOPE is currently recruiting HIV-1 infected subjects with any of the following criteria:
1. Documented HIV viral load less than 2000 copies/ml WITHOUT taking antiretroviral
therapy
2. Undetectable HIV viral load with CD4 T-cells consistently less than 350 for the last
12 months while taking a stable antiretroviral regimen.
3. Antiretroviral naive and planning to start an antiretroviral regimen - any CD4 or HIV
viral load acceptable.
4. 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:
1. Active opportunistic infection or systemic treatment for opportunistic infection
within the last 4 months (oral candidiasis acceptable)
2. Active treatment for cancer
3. Active treatment for hepatitis C requiring interferon based therapy
4. Immunosuppressive therapy taken within the last 4 months
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| NCT ID: |
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NCT00187512 |
| Primary Contact: |
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Principal Investigator Steven G. Deeks, M.D. University of California, San Francisco
Rebecca Hoh, M.S., R.D. Phone: 415-476-4082 ext. 139 Email: rhoh@php.ucsf.edu
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| Backup Contact: |
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Email: jmadamba@php.ucsf.edu Joy Madamba, B.S. Phone: 415-476-4082 ext. 155
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| Location Contact: |
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San Francisco, California 94110 United States
Rebecca Hoh, M.S. Phone: 415-476-4082 Email: rhoh@php.ucsf.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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