Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002418
Status:
TERMINATED
Last Update Posted:
2008-08-14
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With 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 Viramune Nevirapine and MKC-442 With or Without Hydroxyurea for the Treatment of HIV-1 Infection in Non-Nucleoside Reverse Transcriptase Inhibitor Naive Patients Who Failed Previous Protease Inhibitor Treatment
Status:
TERMINATED
Status Verified Date:
2000-03
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 a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors NNRTIs and who have failed to respond to protease inhibitors PIs The drug combination will contain didanosine ddI plus stavudine d4T plus nevirapine NVP plus MKC-442 Hydroxyurea HU may be added
Detailed Description:
Patients receive a regimen of didanosine stavudine nevirapine and MKC-442 for 24 weeks Throughout 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 Patients who experience virologic failure have the option of adding hydroxyurea to their treatment regimen or discontinuing from the study After Week 24 patients with documented virologic response may continue treatment with didanosine stavudine nevirapine and MKC-442 and if applicable hydroxyurea until a change in virologic status occurs ie the patient experiences virologic failure Follow-up visits are conducted every 4 to 12 weeks until permanent discontinuation from the study
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 601 | None | None | None |