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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

May 2, 2002
September 25, 2014
March 2002
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Complete list of historical versions of study NCT00035360 on ClinicalTrials.gov Archive Site
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Phase III PEG-Intron in HIV-infected Patients (Study P00738)
Phase 3 Study of PEG-Intron in Heavily Treatment-experienced, HIV-infected Patients

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • HIV Infections
  • AIDS
Drug: PEG-Intron
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
October 2003
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00035360
P00738
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP