Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200369
Status:
COMPLETED
Last Update Posted:
2009-11-05
First Post:
2005-09-12
Brief Title:
Characterization of the Adherence Threshold for HIV Suppression of a Kaletra-based Regimen
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Characterization of the Adherence Threshold for HIV Suppression of a Kaletra-based Regimen
Status:
COMPLETED
Status Verified Date:
2009-11
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 hypothesis of this study is that the level of adherence necessary to achieve HIV virologic suppression with a ritonavir boosted protease inhibitor regimen ie lopinavirritonavir is less than the 95 rate observed in the published literature with unboosted regimens
Detailed Description:
The existing dogma is that patients receiving highly active antiretroviral therapy HAART to treat their HIV infection must take at least 95 of prescribed doses in order to maintain full suppression of viral replication This belief is largely based on a single study that was performed between 1997 and 1999 Ann Int Med 200013321-30 The vast majority of patients in this study were receiving regimens based on either indinavir nelfinavir ritonavir or saquinavir All of these agents have relatively short half-lives and therefore must be taken on time two or three times per day Newer medications such as lopinavirritonavir Kaletra feature much more favorable pharmacokinetic profiles On the basis of improved pharmacokinetics there is reason to believe that regimens built around such agents may be more forgiving of missed medication doses
This study aims to enroll 90 patients from the MMC ID Clinic who are either receiving or are about to receive Kaletra Patients who agree to participate will be furnished with a MEMS cap a bottle cap that electronically records each time that the bottle is opened and stores the data for computer download and will undergo electronic monitoring of their Kaletra adherence for a period of siz months Adherence data will not be reviewed during the study but at study end and at interim time points the investigators will analyze the MEMS cap data from patients who have completed the study in order to determine the threshold value of adherence necessary to achieve satisfactory rates ie 70-80 of complete virologic suppression
An additional aim of the study is to collect specimens from patients receiving Kaletra based regimens who experience virologic failure and to archive them for possible studies of genotypic and phenotypic resistance in the future
This study aims to enroll 90 patients from the MMC ID Clinic who are either receiving or are about to receive Kaletra Patients who agree to participate will be furnished with a MEMS cap a bottle cap that electronically records each time that the bottle is opened and stores the data for computer download and will undergo electronic monitoring of their Kaletra adherence for a period of siz months Adherence data will not be reviewed during the study but at study end and at interim time points the investigators will analyze the MEMS cap data from patients who have completed the study in order to determine the threshold value of adherence necessary to achieve satisfactory rates ie 70-80 of complete virologic suppression
An additional aim of the study is to collect specimens from patients receiving Kaletra based regimens who experience virologic failure and to archive them for possible studies of genotypic and phenotypic resistance in the future
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 |
|---|---|---|---|
| Abbott Laboratories 378-03-71 | None | None | None |