Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089583
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2004-08-06
Brief Title:
48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone Twice Daily In Pediatric Patients With HIV Infection
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A 48 Week Phase II Non-Comparative Open-label Multi-Cohort Multicenter Study to Evaluate the Safety Tolerability Pharmacokinetics and Antiviral Activity of GW433908Ritonavir BID When Administered to HIV-1 Infected PI-Naïve and Experienced Pediatric Subjects 2 to 18 Years Old and of GW433908 BID Administered to PI-Naïve Pediatric Subjects 2 to 6 Years Old
Status:
COMPLETED
Status Verified Date:
2017-01
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 collect information on the safety and activity of an investigational medicine in patients ages 2 to 18 years old with HIV infection
Detailed Description:
A 48 Week Phase II non-comparative open-label multi-cohort multicenter study to evaluate the safety tolerability pharmacokinetics and antiviral activity of GW433908Ritonavir BID when administered to HIV-1 infected PI-Naive and experienced Pediatric Subjects 2 to 18 years old and of GW433908 BID Administered to PI-Naive Pediatric subjects 2 to 6 years old
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