Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002361
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of an Anti-HIV Drug Combination in HIV-Positive Patients Who Have Failed Previous Treatment With Protease Inhibitors
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multicenter Open-Label 24-Week Study to Evaluate the Safety and Activity of Indinavir Sulfate 800 Mg bid in Combination With Ritonavir 200 Mg bid and Two NRTIs in HIV-1 Infected Patients Who Failed PI Therapy
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 it is safe and effective to give an anti-HIV drug combination containing indinavir and ritonavir to HIV-positive patients who have failed previous treatment with protease inhibitors
Detailed Description:
Patients receive indinavir and ritonavir twice daily plus 2 NRTIs NRTIs are not provided by this study Physical examinations and laboratory tests including plasma viral RNA levels and CD4 cell counts are performed at Day 1 and Weeks 4 8 12 16 20 and 24 or at discontinuation The incidence of serious and drug-related adverse experiences is tabulated to determine drug safety The proportion of patients achieving plasma viral RNA levels below 50 copiesml by UltraSensitive assay are estimated statistically to determine drug efficacy
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 |
|---|---|---|---|
| 088-00 | None | None | None |