Status:
COMPLETED
Comparison of Liquid Kaletra and Low Dose Kaletra Tablets
Lead Sponsor:
Phoenix Children's Hospital
Collaborating Sponsors:
Abbott
Conditions:
HIV Infections
Eligibility:
All Genders
3-18 years
Phase:
NA
Brief Summary
Kaletra (a combination drug with lopinavir and ritonavir) is one of a few effective medications that are approved and available for young children who are HIV+. The liquid form is reported to have a v...
Eligibility Criteria
Inclusion
- HIV+ children aged 3-18.
- Baseline treatment includes liquid Kaletra
- currently on a stable (on same regimen \> 3 months, Viral Load\< 5,000), Highly Active Antiretroviral Therapy (HAART) regimen
- able to take pills or willing to undergo pill training prior to enrollment
- weight must be greater than or equal to 15kg
Exclusion
- Unable to swallow pills
- Concomitant treatment with Rifampin or St. John's Wort which have been shown to decrease plasma concentrations of lopinavir.
- Concurrent use of drugs primarily metabolized by CYP3A, which metabolizes ritonavir: Astemizole, Cisapride, Dihydroergotamine, Ergonovine, Ergotamine, Flecainide, Lovastatin, Methylergonovine, Midazolam, Pimozide, Propafenone, Simvastatin, terfenadine, Triazolam
- Baseline treatment does NOT include Kaletra
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00762320
Start Date
October 1 2008
End Date
July 1 2011
Last Update
March 24 2014
Active Locations (1)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016