Observational study of HIV-1 infected individuals and their responses to treatment
SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era
This study is looking at how HIV-1 affects people and how they respond to treatment by collecting health information and samples from volunteers to learn more about the virus and drug resistance.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT00187512 on ClinicalTrials.gov |
What this trial studies
SCOPE is an observational study that collects clinical data and biological samples from HIV-1 infected volunteers to investigate various factors related to HIV infection and treatment. The study focuses on understanding the natural control of HIV-1, disease progression, and the evolution of drug resistance. Participants are seen at San Francisco General Hospital every four months for interviews, saliva collection, and blood draws, with a strong emphasis on maintaining confidentiality of personal identifiers. The collected specimens will be used for future research on virologic and immunologic responses to HIV.
Who should consider this trial
Good fit: Ideal candidates include HIV-1 infected individuals with specific viral load and treatment history criteria, including long-term non-progressors.
Not a fit: Patients currently undergoing active treatment for opportunistic infections or cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of HIV-1 control and resistance, potentially leading to improved treatment strategies.
How similar studies have performed: Previous studies have shown success in understanding HIV progression and treatment responses, making this approach both relevant and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California
- San Francisco General Hospital — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Steven G. Deeks, M.D. — University of California, San Francisco
- Study coordinator: Rebecca Hoh, M.S., R.D.
- Email: Rebecca.Hoh@ucsf.edu
- Phone: 415-476-4082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.