Comparison of Liquid Kaletra and Low Dose Kaletra Tablets in HIV-Positive Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Phoenix Children's Hospital
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Absolute CD4 and CD4 %
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HIV+ children aged 3-
- •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
Arms & Interventions
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)
Intervention: Low dose Kaletra tablets (Drug)
Outcomes
Primary Outcomes
Absolute CD4 and CD4 %
Time Frame: Baseline, 4 weeks, 12 weeks, 26 weeks
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%.
Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid
Time Frame: Baseline
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.
Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra
Time Frame: Baseline
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.
Lopinavir AUC Ratio of Baseline:Week 4
Time Frame: 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.
Viral Load (VL)
Time Frame: Baseline, Week 4, Week 12 and Week 24
Number of participants who maintained their Viral load undetectable (\< 20 copies/ml) for the duration of the study
Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks
Time Frame: 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
Lopinavir and Ritonavir AUC on Low Dose Tablet
Time Frame: 4 weeks
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.
Secondary Outcomes
- Patient Satisfaction(Baseline, 1 month)
- Symptoms Across All Patients(Baseline, 1 month, 3 months, 6 months)
- Parent Satisfaction(Baseline, 4 week, 12 weeks and 24 weeks)
Investigators
Janice Piatt
Medical Director, Bill Holt Clinic
Phoenix Children's Hospital