Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002419
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
Sponsor:
Gilead Sciences
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase II 24-Week Open-Label Study Designed to Evaluate the Safety Tolerability and Efficacy of Novel Quadruple-Combination Therapy With Preveon Adefovir Dipivoxil Bis-POM PMEA Abacavir 1592U89 Sustiva Efavirenz DMP-266 and Amprenavir 141W94 for the Treatment of HIV-1 Infection in Patients Who Have Failed Previous Protease Inhibitor Treatment
Status:
COMPLETED
Status Verified Date:
1999-11
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 adefovir dipivoxil plus abacavir ABC plus efavirenz EFV plus amprenavir APV to HIV-infected patients who have failed to respond to previous treatment with protease inhibitors PIs
Detailed Description:
Patients receive a treatment regimen of adefovir dipivoxil abacavir efavirenz and amprenavir 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 Patients who experience virologic failure are discontinued from the study After Week 24 patients with documented virologic response are eligible to continue receiving the study treatment and to attend scheduled follow-up visits
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 |
|---|---|---|---|
| ICC 605 | None | None | None |