Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002420
Status:
TERMINATED
Last Update Posted:
2008-08-14
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Didanosine Plus Stavudine Plus Delavirdine Mesylate Plus MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Phase II 24-Week Open-Label Study Designed to Evaluate the Pharmacokinetics Safety Tolerability and Efficacy of Novel Combination Therapy With Videx Didanosine Zerit Stavudine Rescriptor Delavirdine Mesylate and MKC-442 With or Without Hydroxyurea for the Treatment of HIV-1- Infected Patients Who Failed Previous Protease Inhibitor Treatment
Status:
TERMINATED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 MKC-442 didanosine ddI stavudine d4T and delavirdine DLV to HIV-positive patients
Detailed Description:
Patients receive a treatment regimen consisting of didanosine stavudine delavirdine and MKC-442 for 24 weeks During the study patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities Samples for population pharmacokinetics are collected from all patients every 4 weeks Patients who experience virologic failure may add hydroxyurea to their treatment regimen or be discontinued from the study Patients who add hydroxyurea to their regimen and subsequently experience virologic failure are discontinued from the study After Week 24 patients with documented virologic response are eligible to continue receiving study treatment until their plasma HIV-1 RNA levels return to baseline levels For patients receiving hydroxyurea beginning at Week 24 visits are conducted at Weeks 28 32 36 and every 12 weeks thereafter For patients who continue taking didanosine stavudine delavirdine and MKC-442 or who have started hydroxyurea treatment between Weeks 12 and 20 follow-up visits are conducted every 12 weeks or sooner if needed until the patient permanently discontinues study treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ICC 603 | None | None | None |