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

This study is currently recruiting participants.

Verified by University of California, San Francisco, August 2009

First Received: September 13, 2005 Last Updated: August 16, 2009 History of Changes

Sponsor:	University of California, San Francisco
Collaborator:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00187512

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:	Cohort, Prospective
Official Title:	SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

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

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Plasma, serum, PMBCs, saliva

Estimated Enrollment:	2000
Study Start Date:	March 2000
Estimated Study Completion Date:	December 2014

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:

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)
Virologic and immune correlates associated with disease progression
Evolution of antiretroviral drug resistance
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:

Documented HIV viral load less than 2000 copies/ml WITHOUT taking antiretroviral therapy
Detectable HIV viral load while taking an integrase inhibitor (raltegravir/ Isentress, elvitegravir) based regimen.
Detectable HIV viral load while taking a CCR5 inhibitor (maraviroc/ Selzentry, vicriviroc) based regimen.
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

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

Contacts and Locations

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

Contacts

Contact: Rebecca Hoh, M.S.	415-476-4082 ext 139	rhoh@php.ucsf.edu
Contact: Marcia Smith, B.S.	415-476-4082 ext 118	masmith@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: Marcia Smith, B.S. 415-476-4082 ext 118 masmith@php.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

No publications provided

Responsible Party:	University of California, San Francisco ( Steven Deeks, Professor of Medicine )
Study ID Numbers:	H8211-17887-10
Study First Received:	September 13, 2005
Last Updated:	August 16, 2009
ClinicalTrials.gov Identifier:	NCT00187512 History of Changes
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:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection

Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010