Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004852
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-03-02
Brief Title:
Safety and Effectiveness of Lamivudine When Given Once a Day Versus Twice a Day in Combination With Other Anti-HIV Drugs in HIV-Infected Adults Who Have Never Received Anti-HIV Drugs
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase IIIII 48-Week Randomized Double-Blind Controlled Multicenter Study to Evaluate the Efficacy and Safety of Lamivudine 300mg Once Daily Vs Lamivudine 150mg BID in Combination With Zidovudine 300mg BID and Efavirenz 600mg Once Daily in Antiretroviral-Naive Adults With HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
2000-08
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:
The purpose of this study is to look at the safety and effectiveness of receiving lamivudine 3TC once a day versus twice a day as part of an anti-HIV drug combination
Detailed Description:
Patients are randomized to receive the same total dosage of 3TC either twice a day Group 1 or once a day Group 2 in combination with ZDV and EFV over 48 weeks Viral load measurements will be performed at Weeks 4 8 12 16 20 24 and every 8 weeks thereafter
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 |
|---|---|---|---|
| EPV2000 1 | None | None | None |