Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262522
Status:
COMPLETED
Last Update Posted:
2012-02-06
First Post:
2005-12-05
Brief Title:
Study of LopinavirRitonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration When Coadministered With Nucleoside Reverse Transcriptase Inhibitors in Antiretroviral Naive Human Immunodeficiency Virus Type 1 Infected Subjects
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Phase 3 Randomized Open-label Study of LopinavirRitonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration When Coadministered With NRTIs in Antiretroviral Naive HIV-1 Infected Subjects
Status:
COMPLETED
Status Verified Date:
2012-02
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:
The purpose of this study was to compare the safety and tolerability of the to-be-marketed lopinavirritonavir LPVr tablet formulation with the marketed soft gel capsule SGC formulation and to compare the safety tolerability and antiviral activity of once daily QD and twice daily BID dosing of the LPVr tablet formulation in combination with select nucleoside reverse transcriptase inhibitors NRTIs in patients who have not previously received antiretroviral treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-001430-32 | EUDRACT_NUMBER | None | None |