- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005012
Safety and Effectiveness of PEG-Intron in HIV-Infected Patients
June 23, 2005 updated by: Schering-Plough
Antiviral Activity and Tolerability of PEG-Intron in HIV-Infected Subjects Failing HAART
The purpose of this study is to see if it is effective to give PEG-Intron (PEG-IFN) to HIV-infected patients who are not doing well with their current anti-HIV drug combination (HAART).
Study Overview
Detailed Description
At entry, patients undergo HIV genotypic/phenotypic analysis.
Patients continue their current antiretroviral regimen but are randomized to receive one of four doses of PEG-IFN or PEG-IFN placebo administered subcutaneously once per week until results of HIV genotyping/phenotyping are available (approximately 4 weeks).
Patients who respond with a 0.5 log or greater decrease in HIV RNA at Week 4 have optimized HAART added to their ongoing PEG-IFN regimen and are followed for 24 weeks in an observational study.
Study Type
Interventional
Enrollment
250
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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San Juan, Puerto Rico, 009265800
- San Juan Vamc
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California
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Berkeley, California, United States, 94705
- East Bay AIDS Ctr
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District of Columbia
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Washington, District of Columbia, United States, 200091104
- Dupont Circle Physicians Group
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Washington, District of Columbia, United States, 20007
- Georgetown Univ Med Ctr
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Florida
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Altamonte Springs, Florida, United States, 32701
- IDC Research Initiative
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Jacksonville, Florida, United States, 32206
- Duval County Health Department
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Miami, Florida, United States, 33136
- Univ of Miami School of Medicine
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Sarasota, Florida, United States, 34239
- Infectious Diseases Associates
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Georgia
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Atlanta, Georgia, United States, 30339
- Piedmont Physicians at Vinings
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Illinois
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Chicago, Illinois, United States, 60657
- TRIAD Health Practice
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Maryland
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Baltimore, Maryland, United States, 212011192
- Univ of Maryland Institute of Human Virology
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Massachusetts
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Boston, Massachusetts, United States, 02111
- New England Med Ctr / Div of Geo Med & Infect Disease
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Minnesota
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St. Paul, Minnesota, United States, 55101
- Regions Hosp
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington Univ
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New Jersey
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Camden, New Jersey, United States, 08103
- Southwestern New Jersey AIDS Clinical Trials
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East Orange, New Jersey, United States, 07018
- East Orange Veterans Administration Med Ctr
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New York
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New York, New York, United States, 10003
- Beth Israel Med Ctr
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Ohio
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Cleveland, Ohio, United States, 44106
- Univ Hosps of Cleveland
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Philadelphia FIGHT
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Philadelphia, Pennsylvania, United States, 19102
- MCP Hahnemann Univ
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Texas
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Dallas, Texas, United States, 75235
- Amelia Ct Clinic
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Houston, Texas, United States, 77004
- Joseph C Gathe
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
Patients may be eligible for this study if they:
- Have HIV levels of more than 2000 copies/ml.
- Have failed their current HAART (had a significant increase in their HIV levels with HAART).
- Have a CD4 cell count greater than 200 cells/microL.
- Have had more than 6 months of HAART.
- Have been on their current HAART for at least 6 weeks.
- Agree to use an effective method of birth control during the study.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have a history of a serious mental disorder.
- Are allergic to interferons.
- Are pregnant or breast-feeding.
- Are taking certain medications such as ribavirin, hydroxyurea, and ganciclovir.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2000
Study Completion
September 1, 2000
Study Registration Dates
First Submitted
March 29, 2000
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
August 1, 2000
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Anti-Infective Agents
- Antiviral Agents
- Peginterferon alfa-2b
Other Study ID Numbers
- B010
- P00737
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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