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

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2015 by University of California, San Francisco

Sponsor:

Collaborator:

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT00187512

First received: September 13, 2005

Last updated: May 5, 2015

Last verified: May 2015

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Proteinase inhibitor

U.S. FDA Resources

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:	2500
Study Start Date:	March 2000
Estimated Study Completion Date:	December 2020
Estimated Primary Completion Date:	March 2019 (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:

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 (Adult, Senior)
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
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

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	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

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

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.


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:	May 5, 2015
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:


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

ClinicalTrials.gov processed this record on September 29, 2016

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