Phase III PEG-Intron in HIV-infected Patients (Study P00738)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00035360
First received: May 2, 2002
Last updated: October 7, 2015
Last verified: October 2015
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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 |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
| Enrollment: | 49 |
| Study Start Date: | March 2002 |
| Study Completion Date: | October 2003 |
| Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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More Information
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00035360 History of Changes |
| Other Study ID Numbers: | P00738 |
| Study First Received: | May 2, 2002 |
| Last Updated: | October 7, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck Sharp & Dohme Corp.:
|
PEG-Intron treatment experienced |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Peginterferon alfa-2b Interferon-alpha Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 29, 2016