Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040664
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2002-07-05
Brief Title:
A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A 48 Week Phase II Open-Label Multi-Cohort Multicenter Study to Evaluate the Safety Tolerability Pharmacokinetics and Antiviral Activity of GW433908Ritonavir QD and GW433908Ritonavir BID When Administered to HIV-1 Infected Antiretroviral Naive and Experienced Pediatric Subjects 2-18 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 additional information on the safety tolerability pharmacokinetics and antiviral activity of an investigational regimen course of therapy including FDA approved HIV drugs in HIV-infected patients 2 - 18 years old
Detailed Description:
A 48 Week Phase II Open-label Multi-Cohort Multicenter Study to Evaluate the Safety Tolerability Pharmacokinetics and Antiviral Activity of GW433908Ritonavir QD and GW433908Ritonavir BID when Administered to HIV-1 Infected Antiretroviral Naive and Experience Pediatric Subjects 2 to 18 Years Old
ViiV Healthcare is the new sponsor of this study and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
ViiV Healthcare is the new sponsor of this study and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
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