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

a study on HIV/AIDS

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Steven G. Deeks, M.D.

Description

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.

Details

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.

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

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.

You CAN'T join if...

  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

Location

  • San Francisco General Hospital accepting new patients
    San Francisco California 94110 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT00187512
Study Type
Observational
Participants
Expecting 2500 study participants
Last Updated
Contact us about this trial