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

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Lopinavir

U.S. FDA Resources

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 (Adult, Senior)
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:

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
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lopinavir Ritonavir	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

ClinicalTrials.gov processed this record on September 26, 2016

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