Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002241
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multicenter Open-Label 24-Week Pilot Study to Evaluate the Safety and Efficacy of Indinavir Sulfate 800 Mg bid in Combination With Ritonavir 100 Mgd4T3TC bid in HIV-Infected Individuals
Status:
UNKNOWN
Status Verified Date:
2001-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 whether taking indinavir IDV plus ritonavir RTV plus stavudine d4T plus lamivudine 3TC 2 times each day is safe and can lower the level of HIV in the blood
Detailed Description:
Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks Every 4 weeks patients have physical exams and laboratory tests of blood and urine and CD4 cell counts and plasma viral RNA are measured At Week 24 the proportion of patients with plasma viral RNA below 400 copiesml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen An observed response proportion of 80 or higher will be considered clinically meaningful
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 |
|---|---|---|---|
| CRX463 | None | None | None |
| 094-00 | None | None | None |