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NCT01139905 Clinical Trial

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

HIV-1 Infections Clinical Trial

Official title:
Pharmacokinetics of Low- Dose Lopinavir/Ritonavir Tablet Formulation HIV-1 Infected Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01139905
Other study ID # HIV-NAT 100
Secondary ID
Status Completed
Phase Phase 2
First received June 4, 2010
Last updated March 24, 2015
Start date April 2010
Est. completion date March 2011

Study information
Verified date March 2015
Source The HIV Netherlands Australia Thailand Research Collaboration
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 18 Years
Eligibility 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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Other:
• lopinavir/ritonavir
standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour.

Locations
Country Name City State
Thailand HIV-NAT Bangkok

Sponsors (3)
Lead Sponsor Collaborator
The HIV Netherlands Australia Thailand Research Collaboration Chulalongkorn University, UMC St. Radboud, Nijmegen, The Netherlands

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary assess the level of lopinavir trough level >1 mg/L in low dose lopinavir (reduction by 70%) study drug Aluvia (lopinavir/ritonavir 100/25 mg) 4 months No
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