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Lopinavir (LPV) Dose Reduction

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ClinicalTrials.gov Identifier: NCT01159275
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : July 9, 2010
Sponsor:
Collaborator:
Ministry of Education, Thailand
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration

Study Description
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Brief Summary:
The purpose of this study is to study the pharmacokinetics profiles of generic lopinavir/ritonavir and Pediatric Aluvia® at reduced dose by assessing safety, tolerability and efficacy.

Condition or disease Intervention/treatment Phase
HIV-1 Infections Drug: Generic LPV/r and Aluvia (pharmacokinetics) Drug: Aluvia and Generic LPV/r (pharmacokinetics) Phase 1 Phase 2

Detailed Description:
This is a prospective, 2 arms, randomized intensive PK study with cross over design. This design will provide us optimal information to answer our research question. First and most important, we can assess the PK when lopinavir/r is used in a dose reduced form. By randomizing the patients to either Abbott's pediatric Aluvia dose reduction or India generic LPV/r dose reduction will allow us to assess the differences in AE severity and frequency. Using the standard abbott product as a control our study will provide important information about the bioavailability of the generic product. Although it's not an original BE design we must be able to make preliminary comparisons.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetics of Pediatric Aluvia® (Lopinavir /Ritonavir 100/25 mg) and Generic Lopinavir/Ritonavir Tablet Formulation (200/50 mg) in Clinically and Virologically Stable HIV-1 Infected Thai Adults
Study Start Date : July 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lopinavir
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
1
First Generic LPV/r 200/50 mg BID, then cross over to Pediatric Aluvia 200/50 mg BID
 Drug: Generic LPV/r and Aluvia (pharmacokinetics)
Generic LPV/r 200/50 mg BID 12 hr PK then cross over to Pediatric Aluvia 200/50 mg BID
2
First Pediatric Aluvia® 200/50 mg BID, then cross over to Generic LPV/r 200/50 mg BID
 Drug: Aluvia and Generic LPV/r (pharmacokinetics)
First Pediatric Aluvia® 200/50 mg BID, then cross over to Generic LPV/r 200/50 mg BID


Outcome Measures
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Primary Outcome Measures :
  1. AUC, Cmin, Cmax of LPV/r between Aluvia and generic [ Time Frame: week 2 ]
    AUC, Cmin, Cmax of LPV/r between Aluvia and generic


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent
  2. Evidence of HIV infection (confirmed positive ELISA and/or documented history of measurable HIV RNA)
  3. Age> 18 years
  4. Have been on standard dose of any PI containing regimen for at least 4 weeks prior to study entry
  5. Currently having no AIDS defining illness
  6. Plasma HIV RNA < 50 copies/mL for at least 24 weeks
  7. Willing to adhere to the protocol requirements

Exclusion Criteria:

  1. Any history of taking CYP450 inhibitors or inducers, or any gastric acid-reducing drugs within 14 days of enrollment in the study
  2. Current pregnancy or lactating
  3. Active opportunistic infection
  4. ALT/ AST more than 2x upper limit
  5. creatinine more than 1.5 time the upper limit
  6. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion
  7. History of sensitivity/idiosyncrasy to the drug or chemically related compounds or pharmaceutical excipients which may be employed in the study.
  8. Active drug abuse
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): NCT01159275


Locations
Thailand
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, Thailand, 10330
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Ministry of Education, Thailand
Investigators
Principal Investigator: Anchalee Avihingsanon, MD The HIV Netherlands Australia Thailand Research Collaboration
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)  This link exits the ClinicalTrials.gov site

Responsible Party: Anchalee Avihingsanon, HIV-NAT
ClinicalTrials.gov Identifier: NCT01159275     History of Changes
Other Study ID Numbers: HIV-NAT 085
First Posted: July 9, 2010    Key Record Dates
Last Update Posted: July 9, 2010
Last Verified: July 2010

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
lopinavir/ritonavir
pharmacokinetics
HIV-1 infected adults
aim to investigate the lower dose of boosted lopinavir in Thais and to compare the levels of lopinavir/ritonavir from Abbot and GPO

Additional relevant MeSH terms:
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