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

Tracking Information
First Submitted Date ICMJE	December 20, 2006
First Posted Date ICMJE	December 21, 2006
Last Update Posted Date	December 8, 2010
Study Start Date ICMJE	June 2006
Actual Primary Completion Date	April 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 21, 2006)	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; (submitted: December 21, 2006)	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
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	April 2007
Actual 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, Older Adult)
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