Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002401
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients
Sponsor:
Pharmacia and Upjohn
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Open-Label Randomized Study of Delavirdine Mesylate DLV Rescriptor in Triple and Quadruple Combinations With Zidovudine ZDV Indinavir IDV and Lamivudine 3TC in HIV-1 Infected Individuals
Status:
COMPLETED
Status Verified Date:
1999-01
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 delavirdine DLV in combination with two or three other drugs to HIV-infected patients The drugs to be used in combination with DLV are zidovudine ZDV indinavir IDV and lamivudine 3TC
Detailed Description:
In this open-label pilot study patients are randomized to 1of the following 4 arms for 24 weeks
Arm 1 40 patients DLV plus ZDV plus IDV Arm 2 40 patients DLV plus IDV plus 3TC Arm 3 40 patients DLV plus ZDV plus IDV plus 3TC Arm 4 40 patients ZDV plus IDV plus 3TC
Dose determined by body weight Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator
Arm 1 40 patients DLV plus ZDV plus IDV Arm 2 40 patients DLV plus IDV plus 3TC Arm 3 40 patients DLV plus ZDV plus IDV plus 3TC Arm 4 40 patients ZDV plus IDV plus 3TC
Dose determined by body weight Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator
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 |
|---|---|---|---|
| 0074 | None | None | None |