ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00187512
Recruitment Status : Recruiting
First Posted : September 16, 2005
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
HIV Infections

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.


Study Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era
Study Start Date : March 2000
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The general theme of this core is to investigate the relationship between the virologic response to antiretroviral therapy and clinical outcome. [ Time Frame: Ongoing ]

Biospecimen Retention:   Samples With DNA
Plasma, serum, PMBCs, saliva

Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187512


Contacts
Contact: Rebecca Hoh, M.S., R.D. 415-476-4082 ext 139 Rebecca.Hoh@ucsf.edu
Contact: Montha Pao 415-476-4082 ext 140 Montha.Pao@ucsf.edu

Locations
United States, California
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Rebecca Hoh, M.S.    415-476-4082 ext 139    Rebecca.Hoh@ucsf.edu   
Contact: Montha Pao    415-476-4082 ext 140    Montha.Pao@ucsf.edu   
Principal Investigator: Steven G. Deeks, M.D.         
Sponsors and Collaborators
University of California, San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Steven G. Deeks, M.D. University of California, San Francisco
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00187512     History of Changes
Other Study ID Numbers: 10-01330
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by University of California, San Francisco:
HIV
Antiretroviral Agents
Drug Resistance, Multiple
Long Term Non Progression
Long Term Non Progressor
 Elite Suppression
Elite Suppressor
Natural History
Observational

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Protease Inhibitors
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents