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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00187512

Acronym

SCOPE

Enrollment

2500

Registered

2005-09-16

Start date

2000-03-01

Completion date

2033-12-01

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Antiretroviral Agents, Drug Resistance, Multiple, Long Term Non Progression, Long Term Non Progressor, Elite Suppression, Elite Suppressor, Natural History, Observational

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Contacts

CONTACTRebecca Hoh, M.S., R.D.

Rebecca.Hoh@ucsf.edu415-476-4082

CONTACTMontha Pao

Montha.Pao@ucsf.edu415-476-4082

PRINCIPAL_INVESTIGATORSteven G. Deeks, M.D.

University of California, San Francisco

Outcome results