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| Descriptive Information Fields | |
| Brief Title † | Phase III PEG-Intron in HIV-Infected Patients (Study P00738)(COMPLETED) |
| 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 Phase | Phase III |
| Study Type † | Interventional |
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | HIV Infections AIDS |
| Intervention † | Drug: PEG-Intron |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 675 |
| Start Date † | April 2002 |
| Completion Date | March 2004 |
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | |
| Administrative Information Fields | |
| NCT ID † | NCT00035360 |
| Organization ID | P00738 |
| Secondary IDs †† | |
| Study Sponsor † | Schering-Plough |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | Schering-Plough |
| Verification Date | May 2006 |
| First Received Date † | May 2, 2002 |
| Last Updated Date | May 31, 2006 |