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

June 4, 2010
July 8, 2010
July 2009
March 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01159275 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Lopinavir (LPV) Dose Reduction
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

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
HIV-1 Infections
  • 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
  • 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
  • 1
    First Generic LPV/r 200/50 mg BID, then cross over to Pediatric Aluvia 200/50 mg BID
    Intervention: Drug: Generic LPV/r and Aluvia (pharmacokinetics)
  • 2
    First Pediatric Aluvia® 200/50 mg BID, then cross over to Generic LPV/r 200/50 mg BID
    Intervention: Drug: Aluvia and Generic LPV/r (pharmacokinetics)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01159275
HIV-NAT 085
No
Anchalee Avihingsanon, HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
Commission on Higher Education (CHE)
Principal Investigator: Anchalee Avihingsanon, MD The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP