Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT01045369
Status:
COMPLETED
Last Update Posted:
2017-05-01
First Post:
2010-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study of Kaletra and Intelence Tablets in Naive Subjects
Sponsor:
Therapeutic Concepts
Organization:
Study Overview
Official Title:
A Phase IV 48 Week, Open Label, Pilot Study of Kaletra and Intelence Tablets in Naive Subjects
Status:
COMPLETED
Status Verified Date:
2010-01
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:
KALYINTE
Brief Summary:
The purpose of this study is to see if using a combination of other drug classes, like the ones that Kaletra® and Intelence™ belong to, can still help reduce the amount of HIV in your blood. Using Kaletra® and Intelence™ without other drugs is not approved by the FDA and so their use in this study is experimental.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: