Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071760
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2003-10-30
Brief Title:
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A 48 Week Phase II Open-label 2-cohort Multicenter Study to Evaluate the Pharmacokinetics Safety Tolerability and Antiviral Activity of GW433908 and GW433908RTV When Administered to HIV-1 Infected Protease Inhibitor PI Naive and PI-experienced Pediatric Subjects Aged 4 Weeks to 2 Years
Status:
COMPLETED
Status Verified Date:
2023-10
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:
This is a 48-week study to evaluate the safety tolerability pharmacokinetics and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects ages 4 weeks to 2 years old
Detailed Description:
A 48 week Phase II open-label 2-cohort multicenter study to evaluate the pharmacokinetics safety tolerability and antiviral activity of GW433908 and GW433908RTV when administered to HIV-1 infected protease inhibitor PI naive and PI-experienced pediatric subjects aged 4 weeks to 2 years
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