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

Recruiting

• Conditions: HIV Infections

• Registration Number: NCT00187512
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2000-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2032-12
• Study Completion: 2033-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The general theme of this core is to investigate the relationship between the virologic response to antiretroviral therapy and clinical outcome.	Ongoing

Trial Locations

Locations (1)

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States