BOOST: Study of Increased Dosage of Lopinavir/Ritonavir (LPV/r)
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ClinicalTrials.gov Identifier: NCT00414284 |
Recruitment Status
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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.)
First Posted
: December 21, 2006
Last Update Posted
: December 8, 2010
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Tracking Information | ||||
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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 |
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 |
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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:
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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 |
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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. |
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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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |
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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 |