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

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ClinicalTrials.gov Identifier: NCT00414284
Recruitment Status : 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
Sponsor:
Collaborator:
Abbott
Information provided by:
Community Research Initiative of New England

Study Description
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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).

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Increased dose of Kaletra Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the pharmacokinetic parameters of higher doses of LPV/r

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414284


Locations
United States, Massachusetts
Community Research Initiative of New England - Boston
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Community Research Initiative of New England
Abbott
Investigators
Principal Investigator: Calvin J Cohen, MD, MSc CRI
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Web page of CRI, the nonprofit research group sponsoring the study  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00414284     History of Changes
Other Study ID Numbers: 06-124
IND #71128
First Posted: December 21, 2006    Key Record Dates
Last Update Posted: December 8, 2010
Last Verified: December 2010

Keywords provided by Community Research Initiative of New England:
HIV/AIDS
viremia
Kaletra
pharmacokinetics
 viral load
LPV/r
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lopinavir
 HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors