Phase III PEG-Intron in HIV-Infected Patients (Study P00738)(COMPLETED)
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Purpose
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 |
|---|---|---|
|
HIV Infections AIDS |
Drug: PEG-Intron |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00035360 History of Changes |
| Other Study ID Numbers: | P00738 |
| Study First Received: | May 2, 2002 |
| Last Updated: | May 31, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Schering-Plough:
|
PEG-Intron treatment experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Reaferon Interferon Alfa-2b Peginterferon alfa-2b |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Adjuvants, Immunologic Immunologic Factors Alcohol Deterrents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013