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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00005012
First received: March 29, 2000
Last updated: June 23, 2005
Last verified: August 2000

March 29, 2000
June 23, 2005
March 2000
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Complete list of historical versions of study NCT00005012 on ClinicalTrials.gov Archive Site
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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
Endpoint Classification: Efficacy Study
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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
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