Clinical trial NCT00762320: Comparison of Liquid Kaletra and Low Dose Kaletra Tablets
Official title: Comparison of Liquid Kaletra and Low Dose Kaletra Tablets in HIV-Positive Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Kaletra
treatment Experienced
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2008-09-30
Enrollment: 8
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Absolute CD4 and CD4 %
timeFrame: Baseline, 4 weeks, 12 weeks, 26 weeks
measure: Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid
timeFrame: Baseline
measure: Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra
timeFrame: Baseline
measure: Lopinavir AUC Ratio of Baseline:Week 4
timeFrame: Baseline, week 4
measure: Viral Load (VL)
timeFrame: Baseline, Week 4, Week 12 and Week 24
measure: Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks
timeFrame: 4 weeks
measure: Lopinavir and Ritonavir AUC on Low Dose Tablet
timeFrame: 4 weeks
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: Baseline, 1 month
measure: Symptoms Across All Patients
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Parent Satisfaction
timeFrame: Baseline, 4 week, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
Study officials:
affiliation: Phoenix Children's Hospital
name: Janice Piatt, MD
role: PRINCIPAL_INVESTIGATOR
References: