Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Merck Sharp & Dohme Corp.


Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier
NCT00035360

First received: May 2, 2002
Last updated: March 7, 2017
Last Verified: March 2017
History of Changes
Purpose

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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 3 Study of PEG-Intron in Heavily Treatment-experienced, HIV-infected Patients

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

Enrollment: 49
Study Start Date: March 2002
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035360

Sponsors and Collaborators

Merck Sharp & Dohme Corp.
More Information

More Information


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: March 7, 2017  

Keywords provided by Merck Sharp & Dohme Corp.:

PEG-Intron
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Peginterferon alfa-2b
Interferon-alpha

ClinicalTrials.gov processed this data on December 18, 2017
This information is provided by ClinicalTrials.gov.