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

HIV Infections Clinical Trial

— SCOPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00187512
• Other study ID #: 10-01330
• Status: Recruiting
• Start date: March 2000
• Est. completion date: December 2033

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: Rebecca Hoh, M.S., R.D.
• Phone: 415-476-4082
• Email: Rebecca.Hoh[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 2033
• Est. primary completion date: December 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The general theme of this core is to investigate the relationship between the virologic response to antiretroviral therapy and clinical outcome.		Ongoing