Phase III PEG-Intron in HIV-infected Patients (Study P00738)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00035360

First received: May 2, 2002

Last updated: September 25, 2014

Last verified: September 2014

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Phase 3 Study of PEG-Intron in Heavily Treatment-experienced, HIV-infected Patients

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

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

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:


Enrollment:	49
Study Start Date:	March 2002
Study Completion Date:	October 2003

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00035360 History of Changes
Other Study ID Numbers:	P00738
Study First Received:	May 2, 2002
Last Updated:	September 25, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:


PEG-Intron treatment experienced

Additional relevant MeSH terms:


Peginterferon alfa-2b Anti-Infective Agents Antiviral Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

To Top