Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414284
Status:
TERMINATED
Last Update Posted:
2010-12-08
First Post:
2006-12-20
Brief Title:
BOOST Study of Increased Dosage of LopinavirRitonavir LPVr
Sponsor:
Community Research Initiative of New England
Organization:
Community Research Initiative of New England
Study Overview
Official Title:
Evaluation of the Pharmacokinetics and Tolerability of Increased Dosage of LopinavirRitonavirLPVr in Individuals Experiencing Viremia on Standard Dose LPVr Using LPVr Tablet Formulation
Status:
TERMINATED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
One subjects HIV RNA rebounded at week 12 A repeat PhenoSense GT combination resistance assay at week 12 revealed evolution in protease inhibitor resistance
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will look to see if increasing the standard dose of Kaletra is tolerated and if it will lower viral loads to undetectable levels This study will also look at the pharmacokinetic data amount of Kaletra in blood at different times
Detailed Description:
There are several reasons for low level viremia in patients on Kaletra LPVr including poor adherence incomplete absorption cellular drug pumps or resistance mutations Increasing exposure to protease inhibitors via boosting with ritonavir increases minimum blood concentrations and is a strategy which has been shown to improve suppression of virologic replication Little is known about the pharmacokinetics PK tolerability and safety of increased doses of LPVr The objectives of this 24-week single arm pilot study are to assess the PK parameters safety tolerability change in viral load and CD4 counts on increased dose 600150 and 800200 mg LPVr in participants with low level viremia on standard dose LPVr-based ART Participants will undergo six PK samplings over 12 hours on standard dose LPVr The dose will be increased to 3 tabs 600150 BID and blood will be sampled for PK after two weeks If tolerated at 8 weeks the dose will be increased to 4 tabs 800200 mg BID and final PK sampling will be performed after two weeks There will be a one time optional optimization of background regimen of NRTIs two weeks after the first dose escalation
Major Eligibility Criteria
CD4 count 50
Viral load 200-75000 on two most recent measures
Current treatment 16 weeks standard dose 400100mg BID LPVr-based ART no other PI or NNRTI allowed
Prior treatment experience and resistance profile Up to 20-fold resistance to LPVr
Major Eligibility Criteria
CD4 count 50
Viral load 200-75000 on two most recent measures
Current treatment 16 weeks standard dose 400100mg BID LPVr-based ART no other PI or NNRTI allowed
Prior treatment experience and resistance profile Up to 20-fold resistance to LPVr
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 |
|---|---|---|---|
| IND 71128 | None | None | None |