Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006326
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
2000-10-02
Brief Title:
Safety and Effectiveness of 3 Anti-HIV Treatments in Patients Who Have Failed Previous Treatments Containing Nelfinavir
Sponsor:
Agouron Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Open-Label Study to Evaluate 3 Salvage Regimens in HIV-Infected Subjects Experiencing Virologic Failure on an Initial HAART Regimen Containing Nelfinavir
Status:
TERMINATED
Status Verified Date:
2002-07
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:
The purpose of this study is to see if 3 anti-HIV drug combinations are safe and effective in patients who have failed previous anti-HIV treatments using nelfinavir NFV
Detailed Description:
Patients receive 1 of 3 salvage regimens Treatments A and B include delavirdine 1 of 2 doses of indinavir and 2 nucleoside reverse transcriptase inhibitors NRTIs to which the patient has not been exposed Treatment C includes ritonavir indinavir and 2 NRTIs to which the patient has not been exposed When virologic failure is first observed the patient must return in 2 weeks for confirmation of failure and start the salvage regimen within 1 month of the first assay in which failure was observed Patients who have less than 400 copiesml HIV RNA after 16 weeks of therapy are considered responders and continue on the study Those who have more than 400 copiesml after 16 weeks of therapy are considered nonresponders and should be discontinued from the study In addition patients who respond and subsequently rebound with a viral load 05 log above the nadir and greater than 400 copiesml on 2 consecutive assays at least 2 weeks apart are considered treatment failures and should be discontinued from the study Patients have regular physical exams as well as virologic immunologic and pharmacokinetic assessments
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 |
|---|---|---|---|
| 1133 | None | None | None |
| AG1343-1133 | None | None | None |