Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002203
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Two Anti-HIV Drug Combinations
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Multicenter Study of Epivir 150 Mg Bid Retrovir 200 Mg Tid and a Protease Inhibitor Vs 3TC 150 MgZDV 300 Mg Fixed Dose Tablet Given Bid With a Protease Inhibitor in HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
1998-11
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 compare the safety and effectiveness of taking lamivudine 3TC plus zidovudine ZDV plus a protease inhibitor PI with taking the 3TCZDV combination tablet Combivir plus a PI This study also examines how well patients follow the dosing schedules for these drugs
Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI
Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI
Detailed Description:
It is hypothesized that a fixed-dose 3TCZDV tablet given bid in combination with a protease inhibitor is clinically equivalent in its effect on plasma HIV-1 RNA level to a conventional regimen of 3TC ZDV and a protease inhibitor
Patients are stratified according to their current protease inhibitor therapy and randomized to receive open-label therapy of 1 Combivir tablet bid Arm II or an equivalent dose of 3TC and ZDV Arm I plus their current protease inhibitor for 16 weeks
Patients are stratified according to their current protease inhibitor therapy and randomized to receive open-label therapy of 1 Combivir tablet bid Arm II or an equivalent dose of 3TC and ZDV Arm I plus their current protease inhibitor for 16 weeks
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 |
|---|---|---|---|
| NZTA4001 | None | None | None |