Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035360
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2002-05-02
Brief Title:
Phase III PEG-Intron in HIV-infected Patients Study P00738
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Phase 3 Study of PEG-Intron in Heavily Treatment-experienced HIV-infected Patients
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized double-blind multicenter trial testing 2 doses of PEG-Intron 10mcgkgweek and 30mcgkgweek 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 400-50000 copiesML 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 drug will be added to optimized background anti-retroviral therapy of patients whose HIV RNA is incompletely suppressed by their therapy HIV RNA 400-50000 copiesML 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None