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Lopinavir (LPV) Dose Reduction

This study has been completed.
Sponsor:
Collaborator:
Commission on Higher Education (CHE)
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01159275
First received: June 4, 2010
Last updated: July 8, 2010
Last verified: July 2010
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • AUC, Cmin, Cmax of LPV/r between Aluvia and generic [ Time Frame: week 2 ] [ Designated as safety issue: Yes ]
    AUC, Cmin, Cmax of LPV/r between Aluvia and generic


Estimated Enrollment: 20
Study Start Date: July 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159275

Locations
Thailand
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, Thailand, 10330
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Commission on Higher Education (CHE)
Investigators
Principal Investigator: Anchalee Avihingsanon, MD The HIV Netherlands Australia Thailand Research Collaboration
  More Information

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

No publications provided

Responsible Party: Anchalee Avihingsanon, HIV-NAT
ClinicalTrials.gov Identifier: NCT01159275     History of Changes
Other Study ID Numbers: HIV-NAT 085
Study First Received: June 4, 2010
Last Updated: July 8, 2010
Health Authority: Thailand: Ethical Committee

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:
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
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013