Phase III PEG-Intron in HIV-infected Patients (Study P00738)
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ClinicalTrials.gov Identifier: NCT00035360 |
Recruitment Status
:
Completed
First Posted
: May 6, 2002
Last Update Posted
: March 10, 2017
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Tracking Information | |||
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First Submitted Date ICMJE | May 2, 2002 | ||
First Posted Date ICMJE | May 6, 2002 | ||
Last Update Posted Date | March 10, 2017 | ||
Study Start Date ICMJE | March 2002 | ||
Actual Primary Completion Date | October 2003 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | Complete list of historical versions of study NCT00035360 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Phase III PEG-Intron in HIV-infected Patients (Study P00738) | ||
Official Title ICMJE | 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. |
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Study Type ICMJE | Interventional | ||
Study Phase | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: PEG-Intron | ||
Study Arms | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
49 | ||
Original Enrollment ICMJE |
675 | ||
Actual Study Completion Date | October 2003 | ||
Actual Primary Completion Date | October 2003 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Not Provided | ||
Removed Location Countries | Argentina, Brazil, Mexico, Peru, Puerto Rico, Singapore, South Africa, Spain, United States | ||
Administrative Information | |||
NCT Number ICMJE | NCT00035360 | ||
Other Study ID Numbers ICMJE | 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 ICMJE | Merck Sharp & Dohme Corp. | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Merck Sharp & Dohme Corp. | ||
Verification Date | March 2017 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |