Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002393
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Indinavir Taken With or Without DMP 266
Sponsor:
Dupont Merck
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Double-Blind Placebo-Controlled Multicenter Study to Determine the Effectiveness and Tolerability of the Combination of DMP 266 and Indinavir Versus Indinavir in HIV-Infected Patients Receiving Nucleoside Analogue NRTI Therapy
Status:
COMPLETED
Status Verified Date:
1998-07
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 add DMP 266 to an anti-HIV treatment program of indinavir and nucleoside reverse transcriptase inhibitors NRTIs
Detailed Description:
In this double-blind placebo-controlled study 300 patients are randomized to 1 or 2 reverse transcriptase inhibitors of their choice plus blinded therapy on Arm A or B as follows
Arm A DMP 266 placebo plus indinavir Arm B DMP 266 plus indinavir After 16 weeks patients may switch the NRTI portion of their regimen if they meet a treatment failure criterion After the completion of the 24-week period patients have the option to continue on open-label DMP 266 and indinavir
Arm A DMP 266 placebo plus indinavir Arm B DMP 266 plus indinavir After 16 weeks patients may switch the NRTI portion of their regimen if they meet a treatment failure criterion After the completion of the 24-week period patients have the option to continue on open-label DMP 266 and indinavir
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 |
|---|---|---|---|
| DMP 266-020 | None | None | None |