Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children

This study has been completed.
Sponsor:
Collaborators:
Chulalongkorn University
UMC St. Radboud, Nijmegen, The Netherlands
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01139905
First received: June 4, 2010
Last updated: March 24, 2015
Last verified: March 2015

June 4, 2010
March 24, 2015
April 2010
March 2011   (final data collection date for primary outcome measure)
assess the level of lopinavir trough level >1 mg/L in low dose lopinavir (reduction by 70%) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
study drug Aluvia (lopinavir/ritonavir 100/25 mg)
Same as current
Complete list of historical versions of study NCT01139905 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children
Pharmacokinetics of Low- Dose Lopinavir/Ritonavir Tablet Formulation HIV-1 Infected Children

To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai children.

This is an open-label, single arm study to compare standard dose with a new tablet formulation of a lower dose of lopinavir/ritonavir in HIV-1 infected children.

Interventional
Phase 2
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
HIV-1 Infections
Other: lopinavir/ritonavir
standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour.
1
standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour
Intervention: Other: lopinavir/ritonavir
Klinklom A, Puthanakit T, Gorowara M, Phasomsap C, Kerr S, Sriheara C, Ananworanich J, Burger D, Ruxrungtham K, Pancharoen C. Low dose lopinavir/ritonavir tablet achieves adequate pharmacokinetic parameters in HIV-infected Thai adolescents. Antivir Ther. 2012;17(2):283-9. doi: 10.3851/IMP1958. Epub 2011 Nov 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. HIV infection
  2. Age < 18 years old
  3. BW > 25 kg
  4. HIV RNA viral load < 50 copies within 6 months
  5. Written informed consent

Exclusion Criteria:

  1. Active opportunistic infection
  2. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
  3. Use of concomitant medications that may interfere with the pharmacokinetics of lopinavir/ritonavir
Both
1 Year to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01139905
HIV-NAT 100
No
The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
  • Chulalongkorn University
  • UMC St. Radboud, Nijmegen, The Netherlands
Principal Investigator: Kiat Ruxrungtham, MD The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
March 2015

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