Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008554
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-01-13
Brief Title:
Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Randomised Multicenter Parallel Open-Label Study to Compare the Efficacy Safety and Tolerability of GW433908 1400 Mg Bid and Nelfinavir 1250 Mg Bid Over 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Adults
Status:
UNKNOWN
Status Verified Date:
2001-07
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 GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs
Detailed Description:
Patients are randomized in a 21 scheme to 1 of 2 treatment groups Group 1 receives GW433908 plus abacavir ABC plus lamivudine 3TC Group 2 receives nelfinavir NFV plus ABC plus 3TC Patients undergo safety and efficacy assessments at the Screening Visit Day 1 Entry and Weeks 1 2 4 8 12 16 20 24 and every 8 weeks thereafter A follow-up visit is performed 4 weeks after the permanent discontinuation of study drug Detailed assessments for the development of lipodystrophyfat redistribution occur at Day 1 Week 24 Week 48 and every 16 weeks thereafter Patients have examinations and laboratory tests performed at visits
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 |
|---|---|---|---|
| APV30001 | None | None | None |