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

  • STATUS
    Recruiting
  • End date
    Dec 4, 2023
  • participants needed
    2500
  • sponsor
    University of California, San Francisco
Updated on 4 June 2022
antiretroviral
antiretroviral agents
antiretroviral therapy
hiv viral load
protease
HIV Vaccine
hiv-1 infection

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.

Details
Condition HIV Infections
Clinical Study IdentifierNCT00187512
SponsorUniversity of California, San Francisco
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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