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.
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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
Drug: Peginterferon alfa-2b
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.
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Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.