FindTrial
Sign In

Double dose Kaletra in children

Doubling The Dose Of Lopinavir/Ritonavir As An Approach To Using Kaletra® In TB/HIV-infected Patients Receiving Rifampicin-based TB Treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR2008060000852767
Enrollment
Unknown
Registered
2009-04-20
Start date
2007-08-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS Tuberculosis

Interventions

Lopinavir (LPV)/Ritonavir (RTV)

Sponsors

University of Cape Town
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: HIV-infected children with and without TB (controls) aged 6 months to 15 years. Children eligible for, or, established on protease inhibitor- based HAART according to National Treatment Guidelines

Exclusion criteria

Exclusion criteria: ALT > 10X the upper limit of normal (grade 3 or 4). Known renal, hepatic or chronic GIT disease. Receiving drugs other than the study medication known to potently induce or inhibit CYP3A4 or alter the PK of LPV.

Design outcomes

Primary

MeasureTime frame
Trough (pre-dose) LPV concentrations—

Secondary

MeasureTime frame
Efficacy;Parmacokinetics of LPV and RTV in the study population;Safety—

Countries

South Africa

Contacts

Public ContactMarque Venter

Research Manager

marque.venter@uct.ac.za0214066659

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026