Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002215
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Randomized Double-Blind Study of MKC-442 Combined With Viracept in Patients Who Are Epivir Retrovir Experienced and Are Protease Inhibitor- and Non-Nucleoside Reverse Transcriptase Inhibitor-Naive
Sponsor:
Triangle Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Double-Blind Study of MKC-442 Combined With Viracept in Patients Who Are Epivir Retrovir Experienced and Are Protease Inhibitor- and Non-Nucleoside Reverse Transcriptase Inhibitor-Naive
Status:
COMPLETED
Status Verified Date:
1999-04
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:
To compare the proportion of patients whose plasma HIV-1 RNA level falls and remains below the limit of quantification by the Roche Amplicor Monitor 400 copiesmlAS PER AMENDMENT 8498 50 copiesml between weeks 0 and 24 To determine the short-term safety and tolerability of MKC-442 plus nelfinavir Viracept plus dual nucleoside analogs To determine the time to viral failure and time to tolerability failure through Week 48 of therapy
Detailed Description:
In this randomized placebo-controlled study patients are allowed to switch at entry to d4T plus 3TC or d4T plus ddI based on investigator and patient preference Patients are stratified based on the number of nucleoside reverse transcriptase inhibitor NRTI treatments that are changed at entry and on screening HIV-1 RNA obtained within 30 days of entry as follows switched 1 NRTI and 10000-50000 copiesml vs switched 1 NRTI and greater than 50000 copiesml vs switched 2 NRTIs and 10000-50000 copiesml vs switched 2 NRTIs and greater than 50000 copiesml Patients are randomized within each of these strata to 1 of the following treatment arms
Arm 1 MKC-442 placebo plus nelfinavir Arm 2 MKC-442 plus nelfinavir Arm 3 MKC-442 plus nelfinavir higher dose Treatment is administered for 48 weeks Patients who are considered virologic successes at Week 48 may continue to receive MKC-442 at the discretion of the investigator
Arm 1 MKC-442 placebo plus nelfinavir Arm 2 MKC-442 plus nelfinavir Arm 3 MKC-442 plus nelfinavir higher dose Treatment is administered for 48 weeks Patients who are considered virologic successes at Week 48 may continue to receive MKC-442 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 |
|---|---|---|---|
| MKC-303 | None | None | None |