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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00035360 |
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 |
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HIV Infections AIDS |
Drug: PEG-Intron |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 3 Study of PEG-Intron in Heavily Treatment-Experienced, HIV-Infected Patients |
Estimated Enrollment: | 675 |
Study Start Date: | April 2002 |
Estimated Study Completion Date: | March 2004 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | P00738 |
Study First Received: | May 2, 2002 |
Last Updated: | May 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00035360 |
Health Authority: | United States: Food and Drug Administration |
PEG-Intron treatment experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Peginterferon alfa-2b Interferon Alfa-2b Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Therapeutic Uses |
Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |