Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002235
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors NNRTIs or Protease Inhibitors
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase II 48-Week Open-Label Study Designed to Evaluate the Safety Tolerability and Efficacy of a Simplified Dosing Regimen of Viracept Nelfinavir Mesylate 1250 Mg BID Crixivan Indinavir Sulfate 1200mg q12h and Sustiva Efavirenz DMP-266 600 Mg q24h for the Treatment of HIV-1 Infection in Non-Nucleoside Reverse Transcriptase Inhibitor and Protease Inhibitor Naive Patients
Status:
COMPLETED
Status Verified Date:
2000-03
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:
Indinavir is usually taken three times a day The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir also taken twice a day and efavirenz taken once a day
Detailed Description:
Patients receive a treatment regimen consisting of nelfinavir indinavir and efavirenz for 48 weeks During the study patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities After Week 48 patients with documented virologic response are eligible to continue receiving study treatments and to attend scheduled follow-up visits Patients who experience virologic failure are discontinued from the study
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 |
|---|---|---|---|
| ICC 602 | None | None | None |