Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002124
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Double-Blind Randomized Dose Response Study of Three Doses of Delavirdine Mesylate U-90152S in Combination With Zidovudine ZDV Versus ZDV Alone in HIV-1 Infected Individuals With CD4 Counts of 200-500mm3
Sponsor:
Pharmacia and Upjohn
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Double-Blind Randomized Dose Response Study of Three Doses of Delavirdine Mesylate U-90152S in Combination With Zidovudine ZDV Versus ZDV Alone in HIV-1 Infected Individuals With CD4 Counts of 200-500mm3
Status:
COMPLETED
Status Verified Date:
1997-07
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:
PART I To evaluate the safety tolerance efficacy and pharmacokinetics of three fixed doses of delavirdine mesylate DLV in combination with zidovudine AZT versus AZT alone in HIV-positive patients
PART II To evaluate the safety tolerance efficacy and pharmacokinetics of ZDV plus 3TC with or without DLV versus ZDV plus DLV in HIV-positive patients
PART II To evaluate the safety tolerance efficacy and pharmacokinetics of ZDV plus 3TC with or without DLV versus ZDV plus DLV in HIV-positive patients
Detailed Description:
PART I Patients are originally randomized to receive ZDV plus DLV DLV at 1 of 3 doses or ZDV plus placebo
AS PER AMENDMENT 3796
PART II Patients are rerandomized from PART I Arm I ZDV plus 3TC plus placebo Arm II ZDV plus 3TC plus DLV Arm III ZDV plus DLV DLV at a higher dose than in the original protocol Arm IV ZDV plus DLV no change from original same treatment as Arm III
AS PER AMENDMENT 12497 Approximately 450 more patients will be enrolled in one of these 3 revised arms on PART II Half of these new patients will be anti-retroviral naive and half will be anti-retroviral experienced
AS PER AMENDMENT 3796
PART II Patients are rerandomized from PART I Arm I ZDV plus 3TC plus placebo Arm II ZDV plus 3TC plus DLV Arm III ZDV plus DLV DLV at a higher dose than in the original protocol Arm IV ZDV plus DLV no change from original same treatment as Arm III
AS PER AMENDMENT 12497 Approximately 450 more patients will be enrolled in one of these 3 revised arms on PART II Half of these new patients will be anti-retroviral naive and half will be anti-retroviral experienced
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 |
|---|---|---|---|
| M33310021 | None | None | None |