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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 28, 2014
Last verified: October 2014
  Purpose

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
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Plasma, serum, PMBCs, saliva


Estimated Enrollment: 2000
Study Start Date: March 2000
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187512

Contacts
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

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    rhoh@php.ucsf.edu   
Contact: Joy Madamba, B.S.    415-476-4082 ext 155    jmadamba@php.ucsf.edu   
Principal Investigator: Steven G. Deeks, M.D.         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Steven G. Deeks, M.D. University of California, San Francisco
  More Information

Additional Information:
No publications provided by University of California, San Francisco

Additional 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
Study First Received: September 13, 2005
Last Updated: October 28, 2014
Health Authority: United States: Institutional Review Board

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014