Comparison of Liquid Kaletra and Low Dose Kaletra Tablets

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762320
• Other study ID #: 08-017
• Status: Completed
• Phase: N/A
• First received: September 29, 2008
• Last updated: February 5, 2014
• Start date: October 2008
• Est. completion date: July 2011

Study information

• Verified date: February 2014
• Source: Phoenix Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Low dose Kaletra tablets
Lopinavir/Ritonavir tablets 100mg/25mg

Locations

Country	Name	City	State
United States	Phoenix Children's Hospital	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Phoenix Children's Hospital	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute CD4 and CD4 %	Number of participants who had no clinically significant deterioration in absolute CD4 and % CD4 count for the duration of the study. Absolute CD4 and Percent CD4 counts were determined by single or dual platform analysis performed on blood samples by Phoenix Children's Hospital Laboratory, Sonora Quest Laboratory or Labcorp Laboratory. Clinically significant change was determine to be a deterioration in both Absolute CD4 to less than 500 and %CD4 to less than 25%.	Baseline, 4 weeks, 12 weeks, 26 weeks	Yes
Primary	Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid	Cmax values at baseline (participants are taking liquid Kaletra as part of baseline treatment). Time points for data collection: 0, 2hrs post dose, 4 hrs post dose, 8 hrs post dose.	Baseline	No
Primary	Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra	Area under the curve values for lopinavir at baseline when participants are taking liquid Kaletra as part of their baseline treatment. Time points for data collection: 0, 2 hrs post, 4 hrs post, 6 hrs post, 8 hrs post.	Baseline	No
Primary	Lopinavir AUC Ratio of Baseline:Week 4	Ratio of AUC at baseline (liquid)to week 4 (reduced dose tablet). AUC data were collected at 0, 2, 4, 6, and 8 hours post dose.	Baseline, week 4	No
Primary	Viral Load (VL)	Number of participants who maintained their Viral load undetectable (< 20 copies/ml) for the duration of the study	Baseline, Week 4, Week 12 and Week 24	Yes
Primary	Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks	Lpv and rtv Cmax at 4 weeks when participants are receiving study intervention, low dose Kaletra. Time points for data collection: 0, 2hrs, 4hrs, 6hrs, 8hrs	4 weeks	No
Primary	Lopinavir and Ritonavir AUC on Low Dose Tablet	Lopinavir and Ritonavir AUC at 4 weeks when participants are receiving the study intervention, low dose tablet formulation of Kaletra. Data collection points for AUC were 0, 2, 4, 6, and 8 hours post dose.	4 weeks	No
Secondary	Patient Satisfaction	Patient Satisfaction Survey. Eight item Likert scale of patient satisfaction with their HIV treatment regimen for patients 7 years of age and older. Items scores are summed to compute a total score. Total scores are reported with a minimum of 0 and a maximum of 32, with higher scores indicating higher satisfaction.	Baseline, 1 month	No
Secondary	Symptoms Across All Patients	Cumulative tally of symptoms for each patients across all visits. Targetted symptoms were asked for at each visit and patients and parents were encouraged to report additional symptoms that were experienced. Each patient got a score for the total number of symptoms at each visit. Scores were totalled, but it the same symptoms occurred continuously it was counted as 1 symptom.	Baseline, 1 month, 3 months, 6 months	No
Secondary	Parent Satisfaction	Parent Satisfaction Survey. Eight item Likert scale of parent/guardian satisfaction with the child's HIV treatment regimen. Item scores are summed to compute a total score. Total scores are reported with a minimum of 0 and a maximum of 32, with higher scores indicating higher satisfaction.	Baseline, 4 week, 12 weeks and 24 weeks	No