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

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

MedlinePlus related topics:

AIDS AIDS Medicines

ChemIDplus related topics:

Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Peginterferon Alfa-2b

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Efficacy Study

Official Title:	Antiviral Activity and Tolerability of PEG-Intron in HIV-Infected Subjects Failing HAART

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

Study ID Numbers:	B010, P00737
First Received:	March 29, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00005012
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

Study placed in the following topic categories:

Interferon-alpha

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Interferons

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Peginterferon alfa-2b

Interferon Alfa-2a

Interferon Alfa-2b

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Therapeutic Uses

Lentivirus Infections

Infection

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008

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