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

This study has been completed.

First Received: March 29, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	Schering-Plough
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00005012

Purpose

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	Intervention	Phase
HIV Infections	Drug: Peginterferon alfa-2b	Phase II

Study Type:	Interventional
Study Design:	Treatment, Efficacy Study
Official Title:	Antiviral Activity and Tolerability of PEG-Intron in HIV-Infected Subjects Failing HAART

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Interferon alfa-2b Peginterferon Alfa-2b

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:	250
Study Start Date:	March 2000
Estimated Study Completion Date:	September 2000

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.

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005012

Show 22 Study Locations

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Study ID Numbers:	B010, P00737
Study First Received:	March 29, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00005012 History of Changes
Health Authority:	United States: Food and Drug Administration

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:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Infection
Angiogenesis Inhibitors
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Peginterferon alfa-2b
Growth Inhibitors
Angiogenesis Modulating Agents
Interferon Alfa-2b
Retroviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009