Comparison of Liquid Kaletra and Low Dose Kaletra Tablets

NCT ID: NCT00762320

Last Updated: 2014-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-07-31

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 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.

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low dose Kaletra tablets

Patients will serve as their own controls as they are switched from the baseline treatment with liquid Kaletra to the study intervention treatment with Low Dose Tablet Kaletra (100mg/25mg)

Group Type: EXPERIMENTAL

Low dose Kaletra tablets

Intervention Type: DRUG

Lopinavir/Ritonavir tablets 100mg/25mg

Interventions

Low dose Kaletra tablets

Lopinavir/Ritonavir tablets 100mg/25mg

Intervention Type: DRUG

Other Intervention Names

lopinavir/ritonavir 100mg/25mg

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Phoenix Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Janice Piatt

Medical Director, Bill Holt Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janice Piatt, MD

Role: PRINCIPAL_INVESTIGATOR

Phoenix Children's Hospital

Locations

Phoenix Children's Hospital

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

08-017

Identifier Type: -

Identifier Source: org_study_id