SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era
Recruiting · NCT00187512 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of California, San Francisco
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- San Francisco General Hospital - San Francisco, California, United States