Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002208
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Multicenter Open-Label Randomized 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate 800 Mg q 8 h Versus 1200 Mg q 12 h in Combination With Zidovudine and 3TC
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multicenter Open-Label Randomized 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate 800 Mg q 8 h Versus 1200 Mg q 12 h in Combination With Zidovudine and 3TC
Status:
COMPLETED
Status Verified Date:
2003-02
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:
To demonstrate that the antiviral activity and safetytolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine ZDV or stavudine d4T and lamivudine 3TC for 24 weeks to protease inhibitor- and 3TC-naive HIV-1-seropositive patients To characterize the steady-state pharmacokinetic profiles of indinavir ZDV or d4T and 3TC in the presence of each other for both the control and test regimen groups
Detailed Description:
Patients are randomized to 1 of 2 arms
Arm A Indinavir plus ZDV plus 3TC Arm B Indinavir test dose plus ZDV plus 3TC NOTE d4T may be substituted for zidovudine for toxicity management Patients are stratified based on prior use of nucleoside analogs naive vs experienced to ZDV dideoxyinosine ddI dideoxycytidine ddC and d4T and screening viral RNA results lower than 50000 copiesmL vs more than 50000 copiesmL
Arm A Indinavir plus ZDV plus 3TC Arm B Indinavir test dose plus ZDV plus 3TC NOTE d4T may be substituted for zidovudine for toxicity management Patients are stratified based on prior use of nucleoside analogs naive vs experienced to ZDV dideoxyinosine ddI dideoxycytidine ddC and d4T and screening viral RNA results lower than 50000 copiesmL vs more than 50000 copiesmL
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 |
|---|---|---|---|
| 069-00 | None | None | None |