Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011895
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-03-02
Brief Title:
Safety and Effectiveness of TRIZIVIR AbacavirLamivudineZidovudine With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Sponsor:
GlaxoSmithKline
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase IV Multicenter Study of the Efficacy and Safety of 48-Week Induction Treatment With TRIZIVIR Abacavir 300 MgLamivudine 150 MgZidovudine 300 Mg Combination Tablet BID With Efavirenz 600 Mg QD Followed by 48-Week Randomized Open-Label Maintenance Treatment With TRIZIVIR With or Without Efavirenz in HIV-1 Infected Antiretroviral Therapy Naive 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 determine the effect of treatment with Trizivir TZV plus efavirenz EFV or TZV alone on viral load level of HIV in the blood
Detailed Description:
Patients receive TZV plus EFV in the 48-week Induction Phase Eligible patients defined as those with plasma HIV-1 RNA under 50 copiesml participate in the 48-week Maintenance Phase Patients are randomized equally to receive either TZV plus EFV or TZV alone
An immunology substudy will be conducted including approximately the first 100 patients enrolled who agree to participate
An immunology substudy will be conducted including approximately the first 100 patients enrolled who agree to participate
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 |
|---|---|---|---|
| ESS40013 | None | None | None |