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

This study is currently recruiting participants.
Verified January 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00187512
First received: September 13, 2005
Last updated: January 7, 2014
Last verified: January 2014

September 13, 2005
January 7, 2014
March 2000
March 2015   (final data collection date for primary outcome measure)
The general theme of this core is to investigate the relationship between the virologic response to antiretroviral therapy and clinical outcome. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00187512 on ClinicalTrials.gov Archive Site
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SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era
SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Plasma, serum, PMBCs, saliva

Non-Probability Sample

The study is open to eligible subjects who are able to perform study visits at San Francisco General Hospital or the San Francisco VA Medical Center.

HIV Infections
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Favre D, Stoddart CA, Emu B, Hoh R, Martin JN, Hecht FM, Deeks SG, McCune JM. HIV disease progression correlates with the generation of dysfunctional naive CD8(low) T cells. Blood. 2011 Feb 17;117(7):2189-99. doi: 10.1182/blood-2010-06-288035. Epub 2011 Jan 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
December 2018
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Rebecca Hoh, M.S., R.D. 415-476-4082 ext 139 rhoh@php.ucsf.edu
Contact: Joy Madamba, B.S. 415-476-4082 ext 155 jmadamba@php.ucsf.edu
United States
 
NCT00187512
10-01330
No
University of California, San Francisco
University of California, San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Steven G. Deeks, M.D. University of California, San Francisco
University of California, San Francisco
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP