Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002424
Status:
SUSPENDED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multicenter Double-Blind Randomized Pilot Study to Compare the Safety and Activity of L-756423Indinavir 1600800 Mg Qd or 800400 Mg Bid Versus Indinavir 800 Mg q8h All in Combination With Stavudine and Lamivudine
Status:
SUSPENDED
Status Verified Date:
2000-04
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:
This study will see how safe and effective against HIV the drugs L-756423 plus indinavir IDV are compared to just IDV when taken with stavudine d4T and lamivudine 3TC The study will also see whether taking 1 large dose of L-756423IDV once a day is as safe and effective as taking 2 smaller doses twice a day
Detailed Description:
Patients are randomized to 1 of 4 treatment arms In Group 1 patients receive a dose of L-756423IDV once daily plus IDV placebo In Group 3 patients receive a lower dose of L-756423IDV twice daily with the daily dosage equaling that of Group 1 plus IDV placebo In Groups 2 and 4 patients receive equal dosages of IDV plus L-756423IDV placebo In all 4 groups L-756423 and IDV are blinded to the investigator and patient All groups receive open-label d4T and 3TC Patients routinely undergo a physical exam and have blood and urine tests to ensure the drugs safety and tolerability which will be evaluated by tabulation of adverse events and clinical assessment of laboratory data In addition CD4 T cell and plasma viral RNA levels are measured to quantify the drugs antiretroviral activity
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 |
|---|---|---|---|
| 009-00 | None | None | None |
| 009-01 | None | None | None |