Ignite Creation Date:
2024-05-04 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002211
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Giving Combinations of Three or Four Anti-HIV Drugs to 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 Plus Nelfinavir NFV Didanosine ddI and Stavudine d4T in Triple and Quadruple Treatment Regimens in HIV-1 Infected Individuals
Status:
COMPLETED
Status Verified Date:
2000-04
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 combinations of three or four anti-HIV drugs to HIV-infected patients The drugs used in this study are delavirdine DLV nelfinavir NLF didanosine ddI and stavudine d4T
Detailed Description:
This is a multicenter open-label study Patients are stratified by HIV-1 RNA levels 20000 to 200000 copiesml and greater than 200000 copiesml Patients are equally randomized to one of four groups and receive antiretroviral therapy for 24 weeks Group 1 receives delavirdine DLV plus nelfinavir NFV plus stavudine d4T Group 2 receives DLV plus NFV plus didanosine ddI Group 3 receives NFV plus d4T plus ddI Group 4 receives DLV plus NFV plus d4T plus ddI Patients are evaluated for drug safety and viral burden Patients may opt to continue on the 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 |
|---|---|---|---|
| 0073 | None | None | None |