Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009061
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-01-23
Brief Title:
Comparison of GW433908Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Open-Label Two Arm Trial to Compare the Safety and Antiviral Efficacy of GW433908Ritonavir QD to Nelfinavir BID When Used in Combination With Abacavir and Lamivudine for 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Subjects
Status:
UNKNOWN
Status Verified Date:
2002-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 compare virus response to GW433908ritonavir RTV to viral response to nelfinavir NFV when used with abacavir ABClamivudine 3TC in patients that have not taken antiretroviral ART drugs
Detailed Description:
Patients are randomized to 1 of 2 treatment arms One arm is treated with GW433908RTV plus ABC and 3TC The other is treated with NFV plus ABC and 3TC Each group is treated for 48 weeks The following are compared in the 2 arms 1 magnitude and durability of antiviral response 2 safety tolerance and antiviral response after 24 and 48 weeks of therapy 3 time to treatment failure 4 immunologic response 5 occurrence of events related to metabolic abnormalities and 6 development of viral resistance in a subset of patients following treatment Also studied are 1 steady-state plasma drug trough concentrations 2 demographic virologic immunologic pharmacologic and adherence factors that may be associated with treatment outcome 3 patient adherence to the drug regimens 4 study medication utilization and 5 resource utilization
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 |
|---|---|---|---|
| APV30002 | None | None | None |