BOOST: Study of Increased Dosage of Lopinavir/Ritonavir (LPV/r)

This study has been terminated.

(One subject's HIV RNA rebounded at week 12. A repeat PhenoSense GT combination resistance assay at week 12 revealed evolution in protease inhibitor resistance.)

Sponsor:

Collaborator:

Abbott

Information provided by:

Community Research Initiative of New England

ClinicalTrials.gov Identifier:

NCT00414284

First received: December 20, 2006

Last updated: December 6, 2010

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

December 20, 2006

Last Updated Date

December 6, 2010

Start Date ^ICMJE

June 2006

Primary Completion Date

April 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the pharmacokinetic parameters of higher doses of LPV/r

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00414284 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate plasma HIV-1 RNA change after increasing the dose of LPV/r
To evaluate change in CD4 count after increased dose LPV/r
To compare the tolerability and laboratory safety profile of LPV/r 3 and 4 tablets BID

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

BOOST: Study of Increased Dosage of Lopinavir/Ritonavir (LPV/r)

Official Title ^ICMJE

Evaluation of the Pharmacokinetics and Tolerability of Increased Dosage of Lopinavir/Ritonavir(LPV/r) in Individuals Experiencing Viremia on Standard Dose LPV/r Using LPV/r Tablet Formulation

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 (LPV/r), 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 LPV/r. 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 (600/150 and 800/200 mg) LPV/r in participants with low level viremia on standard dose LPV/r-based ART. Participants will undergo six PK samplings over 12 hours on standard dose LPV/r. The dose will be increased to 3 tabs (600/150) BID and blood will be sampled for PK after two weeks. If tolerated at 8 weeks, the dose will be increased to 4 tabs (800/200 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: 200-75,000 on two most recent measures
Current treatment: > 16 weeks standard dose (400/100mg BID) LPV/r-based ART (no other PI or NNRTI allowed
Prior treatment experience and resistance profile: Up to 20-fold resistance to LPV/r

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Increased dose of Kaletra

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Not Provided

Completion Date

April 2007

Primary Completion Date

April 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

CD4 Count >50
Viral load 200-75,000 on two most recent measures
More than 16 weeks on standard dose Kaletra (LPV/r)
May be initial PI regimen or prior PI usage
Up to 50-fold resistance to LPV/r

Exclusion Criteria:

Age < 18 years old

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00414284

Other Study ID Numbers ^ICMJE

06-124
IND #71128

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Community Research Initiative of New England

Collaborators ^ICMJE

Abbott

Investigators ^ICMJE

Principal Investigator:

Calvin J Cohen, MD, MSc

CRI

PRS Account

Community Research Initiative of New England

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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