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

- To evaluate the pharmacokinetic parameters of higher doses of LPV/r
- 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

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

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
United States, Massachusetts | |
Community Research Initiative of New England - Boston | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Calvin J Cohen, MD, MSc | CRI |
Additional Information:
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 |