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Completed

NCT Number: NCT00762320

Comparison of Liquid Kaletra and Low Dose Kaletra Tablets

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low dose Kaletra tablets

Drug

Lopinavir/Ritonavir tablets 100mg/25mg

Other names: lopinavir/ritonavir 100mg/25mg

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Phoenix Children's Hospital

Other

Collaborators

  • Abbott

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2008
Registry last updated
Mar 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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