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

• ClinicalTrials.gov Identifier: NCT00035360
• Recruitment Status: Completed
• First Posted: May 6, 2002
• Last Update Posted: March 10, 2017
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Tracking Information

• First Submitted Date: May 2, 2002
• First Posted Date: May 6, 2002
• Last Update Posted Date: March 10, 2017
• Study Start Date: March 2002
• Actual Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase III PEG-Intron in HIV-infected Patients (Study P00738)
• Official Title: Phase 3 Study of PEG-Intron in Heavily Treatment-experienced, HIV-infected Patients
• Brief Summary: 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.

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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment

Condition

• HIV Infections
• AIDS

• Intervention: Drug: PEG-Intron
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 25, 2014): 49
• Original Enrollment (submitted: June 23, 2005): 675
• Actual Study Completion Date: October 2003
• Actual Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Argentina, Brazil, Mexico, Peru, Puerto Rico, Singapore, South Africa, Spain, United States

Administrative Information

• NCT Number: NCT00035360
• Other Study ID Numbers: P00738
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Merck Sharp & Dohme Corp.
• Study Sponsor: Merck Sharp & Dohme Corp.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Merck Sharp & Dohme Corp.
• Verification Date: March 2017