Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT00005118
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment
Sponsor:
Merck Sharp & Dohme LLC
Organization:
Study Overview
Official Title:
A Multicenter, Open-Label, 24-Week Study to Evaluate the Efficacy and Safety of Indinavir Sulfate 800 Mg and Ritonavir 200 Mg b.i.d. Plus 2 NRTIs b.i.d. in HIV-1 Infected Individuals Who Require Early Treatment Intervention
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 if it is safe and effective to give indinavir plus ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment.
Detailed Description:
Patients receive indinavir bid plus ritonavir bid, plus 2 NRTIs bid (2 new NRTIs or 1 new NRTI and 1 NRTI without evidence of resistance). CD4 cell counts and plasma viral RNA are measured every 4 weeks for the duration of the study. Physical examination and laboratory tests of blood and urine are performed every 4 weeks for the duration of the study. Chest x-ray and 12-lead ECG are done prestudy.
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?: