Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002452
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-01-17
Brief Title:
A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multicenter Open-Label Pilot Study to Evaluate the Safety and Activity of L-756423Indinavir Sulfate 800400 Mg bid in Combination With Two nRTIs in HIV-Infected Patients Who Failed an Indinavir Containing Regimen
Status:
COMPLETED
Status Verified Date:
2000-02
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:
The purpose of this study is to see if L-756423 an anti-HIV drug is safe to give with indinavir and if it works well at lowering the level of HIV in the blood viral load
Detailed Description:
All patients receive L-756423 plus indinavir plus two licensed nucleoside reverse transcriptase inhibitors NRTIs at least one to which the patient is naive Patients remain on the drug regimen for 12 weeks with possible extension to 16 weeks Patients are evaluated with physical examinations and laboratory tests for blood and urine at Weeks 1 2 4 6 8 and 12 and two weeks post study Plasma viral RNA is measured at Weeks 1 2 4 6 8 and 12 CD4 cell counts are measured at Weeks 248 and 12
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 |
|---|---|---|---|
| 008-00 | None | None | None |