Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005118
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-04-07
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:
NIH AIDS Clinical Trials Information Service
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 bid Plus 2 NRTIs bid 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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 107-00 | None | None | None |
| CRX481 | None | None | None |