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

Tracking Information
First Received Date ^ICMJE	March 29, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	March 2000
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00005012 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Effectiveness of PEG-Intron in HIV-Infected Patients
Official Title ^ICMJE	Antiviral Activity and Tolerability of PEG-Intron in HIV-Infected Subjects Failing HAART
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).
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 Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Efficacy Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Peginterferon alfa-2b
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	250
Completion Date	September 2000
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Puerto Rico

Administrative Information
NCT ID ^ICMJE	NCT00005012
Responsible Party
Study ID Numbers ^ICMJE	B010, P00737
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	August 2000
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP