NCT00187512 · University of California, San Francisco
SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era
(SCOPE)
What this study is about
SCOPE is an observational, forward-looking study of HIV-1 infected volunteers designed to provide a specimen bank of samples with carefully characterized clinical data.
View original scientific 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. 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.
Primary outcome measures
The general theme of this core is to investigate the relationship between the virologic response to antiretroviral therapy and clinical outcome.
Time frame: Ongoing
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Francisco, California
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2025 · Source of record for eligibility and locations