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:

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.

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