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Comparison of Liquid Kaletra and Low Dose Kaletra Tablets

Information source: Phoenix Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Low dose Kaletra tablets (Drug)

Phase: N/A

Status: Completed

Sponsored by: Phoenix Children's Hospital

Official(s) and/or principal investigator(s):
Janice Piatt, MD, Principal Investigator, Affiliation: Phoenix Children's Hospital


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 very nasty taste and presents difficulties for the children who must take the medication twice a day and for their parents who must enforce the medication regimen. The children are often well into their teens before they weigh enough to be able to take the adult dose tablet (200mg/50mg). A new smaller dose tablet (100mg/25mg) is now available. However, it is not known if the liquid and tablet act the same in children. The purpose of this study is to switch children from the baseline treatment with the liquid to the study intervention treatment with 100mg/25mg tablet form of Kaletra. The study will compare children pre-switch and post-switch in terms of how well their HIV is controlled . Comparisons of parent and child satisfaction will also be made. Eight to 10 HIV+ children currently well managed with a medications including liquid Kaletra will be invited to switch from the liquid to the low dose Kaletra tablet. The parent and/or child will complete a satisfaction survey for the liquid Kaletra and lab values will be taken from the chart. At the time of the switch and 1, 3 and 6 months post switch blood tests will be drawn and the parent and/or child will complete the satisfaction survey. In addition, at the switch and 1 month post switch, a day will be spent in clinic with 5 blood draws to see how much of the drug is in the blood stream at different times after the medicine is taken.

Clinical Details

Official title: Comparison of Liquid Kaletra and Low Dose Kaletra Tablets in HIV-Positive Children

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Absolute CD4 and CD4 %

Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid

Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra

Lopinavir AUC Ratio of Baseline:Week 4

Viral Load (VL)

Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks

Lopinavir and Ritonavir AUC on Low Dose Tablet

Secondary outcome:

Patient Satisfaction

Symptoms Across All Patients

Parent Satisfaction


Minimum age: 3 Years. Maximum age: 18 Years. Gender(s): Both.


Inclusion Criteria:

- 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 Criteria:

- 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

Locations and Contacts

Phoenix Children's Hospital, Phoenix, Arizona 85016, United States
Additional Information

Starting date: October 2008
Last updated: February 5, 2014

Page last updated: August 23, 2015

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