Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002234
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-08-30
Brief Title:
Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients
Sponsor:
Gilead Sciences
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Phase II 48 Week Open-Label Study Designed to Evaluate the Efficacy Safety Tolerability and Pharmacokinetics of a Simplified Dosing Regimen of Preveon Adefovir Dipivoxil bis-POM PMEA Videx Didanosine ddI Sustiva Efavirenz DMP-266 and Epivir Lamivudine 3TC Administered Once Daily for the Treatment of HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
2004-11
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 HIV-infected patients a new combination of anti-HIV drugs taken once daily
Detailed Description:
Patients receive a treatment regimen of adefovir dipivoxil didanosine efavirenz and lamivudine for 48 weeks During the study patients are evaluated for changes from baseline in plasma HIV-1 RNA and lymphocyte subsets and for the development of adverse experiences and laboratory toxicities At Weeks 8 12 24 and 48 patients are assessed for adherence to study treatment with a questionnaire Patients who experience virologic failure are discontinued from the study Patients who experience treatment intolerance may have their antiretroviral treatment regimens changed After Week 48 patients with documented virologic response are eligible to continue receiving 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 604 | None | None | None |