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

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.
ClinicalTrials.gov Identifier: NCT00005012
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Peginterferon alfa-2b Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Primary Purpose: Treatment
Official Title: Antiviral Activity and Tolerability of PEG-Intron in HIV-Infected Subjects Failing HAART
Study Start Date : March 2000
Estimated Study Completion Date : September 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005012


  Show 22 Study Locations
Sponsors and Collaborators
Schering-Plough
More Information

ClinicalTrials.gov Identifier: NCT00005012     History of Changes
Other Study ID Numbers: B010
P00737
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: August 2000

Keywords provided by NIH AIDS Clinical Trials Information Service:
Interferon Alfa-2b
Lymphocyte Transformation
CD4 Lymphocyte Count
RNA, Viral
Virus Inhibitors
Anti-HIV Agents
Viral Load

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
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents