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Comparison of Liquid Kaletra and Low Dose Kaletra Tablets

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ClinicalTrials.gov Identifier: NCT00762320
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : March 24, 2014
Last Update Posted : March 24, 2014
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Janice Piatt, Phoenix Children's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Low dose Kaletra tablets Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Liquid Kaletra and Low Dose Kaletra Tablets in HIV-Positive Children
Study Start Date : October 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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)
 Drug: Low dose Kaletra tablets
Lopinavir/Ritonavir tablets 100mg/25mg
Other Name: lopinavir/ritonavir 100mg/25mg


Outcome Measures
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Primary Outcome Measures :
  1. 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%.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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 Outcome Measures :
  1. Patient Satisfaction [ Time Frame: Baseline, 1 month ]
    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.

  2. Symptoms Across All Patients [ Time Frame: Baseline, 1 month, 3 months, 6 months ]
    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.

  3. Parent Satisfaction [ Time Frame: Baseline, 4 week, 12 weeks and 24 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762320


Locations
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Sponsors and Collaborators
Phoenix Children's Hospital
Abbott
Investigators
Principal Investigator: Janice Piatt, MD Phoenix Children's Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Janice Piatt, Medical Director, Bill Holt Clinic, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT00762320     History of Changes
Other Study ID Numbers: 08-017
First Posted: September 30, 2008    Key Record Dates
Results First Posted: March 24, 2014
Last Update Posted: March 24, 2014
Last Verified: February 2014

Keywords provided by Janice Piatt, Phoenix Children's Hospital:
HIV
Kaletra
treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lopinavir
 HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors