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Safety and Effectiveness of PEG-Intron in HIV-Infected Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005012
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
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. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
March 29, 2000
August 31, 2001
December 9, 2005
March 2000
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No Changes Posted
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Safety and Effectiveness of PEG-Intron in HIV-Infected Patients
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).
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.
Interventional
Phase 2
Primary Purpose: Treatment
HIV Infections
Drug: Peginterferon alfa-2b
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
September 2000
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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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00005012
B010
P00737
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Schering-Plough
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NIH AIDS Clinical Trials Information Service
August 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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