SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era

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.

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