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
  Purpose

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 Intervention Phase
HIV Infections
Drug: Increased dose of Kaletra
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Community Research Initiative of New England:

Primary Outcome Measures:
  • To evaluate the pharmacokinetic parameters of higher doses of LPV/r

Secondary Outcome Measures:
  • 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

Study Start Date: June 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00414284     History of Changes
Other Study ID Numbers: 06-124, IND #71128
Study First Received: December 20, 2006
Last Updated: December 6, 2010
Health Authority: United States: Food and Drug Administration

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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014