Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005018
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-04-04
Brief Title:
Safety and Effectiveness of a Combination Anti-HIV Drug Treatment
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase IV 48-Week Randomized Open-Label Multicenter Trial of Abacavir 300mg BIDEfavirenz 600mg QDDidanosine 400mg QD - Hydroxyurea 500mg BID in HIV-1 Infected Subjects Failing Initial Therapy With 3TCZDV or d4T - Protease Inhibitors
Status:
COMPLETED
Status Verified Date:
2000-08
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 HIV-positive patients a combination of anti-HIV drugs abacavir ABC plus efavirenz EFV plus didanosine ddI with and without hydroxyurea HU
Detailed Description:
Patients are randomized into one of two treatment arms ABCEFVddI or ABCEFVddIHU In the second treatment arm patients are further randomized to receive HU beginning at Baseline when ABCEFVddI is started or at Week 8 Delaying HU may help offset the cytopenic effect of HU as reflected in a blunted CD4 cell response Patients are stratified according to their screening plasma HIV-1 RNA level 400 to 10000 copiesml and more than 10000 to 100000 copiesml Participants in the study receive study-related exams lab tests and study medications at no cost over the 48-week treatment period The safety and effectiveness of the non-protease inhibitor rescue therapy is evaluated routinely by measuring viral load and the CD4 cell count as well as the side effects caused by the medications All of the medications are approved by the FDA and are not considered investigational
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 |
|---|---|---|---|
| NZTA4008 | None | None | None |