Phase III PEG-Intron in HIV-Infected Patients (Study P00738)(COMPLETED) - Full Text View

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00035360

Purpose

This is a randomized, double-blind, multicenter trial testing 2 doses of PEG-Intron, 1.0mcg/kg/week and 3.0mcg/kg/week in heavily treatment-experienced HIV-infected patients compared to placebo. The study will evaluate the efficacy and safety of PEG-Intron when added to stable optimized background antiretroviral therapy in this patient population.

Condition	Intervention	Phase
HIV Infections AIDS	Drug: PEG-Intron	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 3 Study of PEG-Intron in Heavily Treatment-Experienced, HIV-Infected Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS

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

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Estimated Enrollment:	675
Study Start Date:	April 2002
Estimated Study Completion Date:	March 2004

Detailed Description:

This study will randomize 675 patients (225 in each of the 3 arms) to either: PEG-Intron 1mcg; 3mcg or Placebo, at 90 centers worldwide. Each center will enroll approximately 10 patients.

Study drug will be added to optimized background anti-retroviral therapy of patients whose HIV RNA is incompletely suppressed by their therapy (HIV RNA 400-50,000 copies/ML) after 2-6 months.

A single dose reduction of 50% will be allowed for toxicity. An Interim Analysis will be conducted when 50% of patients have completed 24 weeks of therapy. The study treatment phase will be 48 weeks with monthly visits for virologic virologic and safety monitoring. The primary endpoint is change in HIV RNA from baseline to week to assess efficacy. Durability of response will be assessed at 48 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV positive
History of virologic failure on at least 2 antiretroviral regimens including exposure to at least one NRTI, one NNRTI and one PI
HIV RNA >400-<50,000 copies/mL
Laboratory parameters: platelet count (75,000u/L, hemoglobin >9gm/dl, absolute neutrophil count >1,000/uL, SGOT/SGPT<5xULN.

Exclusion Criteria:

Current ribavirin therapy
Subjects with a recent diagnosis or history of moderate or severe depression requiring ongoing psychiatric intervention
Females of childbearing potential who are breastfeeding, who are pregnant, or not using adequate birth control measures
Concomitant use of immunosuppressants or cytotoxic agents
History of seizure disorder requiring use of anticonvulsants

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	P00738
Study First Received:	May 2, 2002
Last Updated:	May 31, 2006
ClinicalTrials.gov Identifier:	NCT00035360 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

PEG-Intron
treatment experienced

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
Peginterferon alfa-2b
Lentivirus Infections
Growth Inhibitors
Angiogenesis Modulating Agents
Retroviridae Infections
Interferon Alfa-2b

ClinicalTrials.gov processed this record on November 25, 2009