Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005012
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-03-29
Brief Title:
Safety and Effectiveness of PEG-Intron in HIV-Infected Patients
Sponsor:
Schering-Plough
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Antiviral Activity and Tolerability of PEG-Intron in HIV-Infected Subjects Failing HAART
Status:
COMPLETED
Status Verified Date:
2000-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if it is effective to give PEG-Intron PEG-IFN to HIV-infected patients who are not doing well with their current anti-HIV drug combination HAART
Detailed Description:
At entry patients undergo HIV genotypicphenotypic analysis Patients continue their current antiretroviral regimen but are randomized to receive one of four doses of PEG-IFN or PEG-IFN placebo administered subcutaneously once per week until results of HIV genotypingphenotyping are available approximately 4 weeks Patients who respond with a 05 log or greater decrease in HIV RNA at Week 4 have optimized HAART added to their ongoing PEG-IFN regimen and are followed for 24 weeks in an observational study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P00737 | None | None | None |