Comparison of Liquid Kaletra and Low Dose Kaletra Tablets

NCT00762320 | Completed Results

• 1 other identifier: 08-017
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV; Kaletra; treatment Experienced

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

Low dose Kaletra tablets

EXPERIMENTAL

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

Interventions

Low dose Kaletra tablets DRUG

Lopinavir/Ritonavir tablets 100mg/25mg

Also known as: lopinavir/ritonavir 100mg/25mg

Low dose Kaletra tablets

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Phoenix Children's Hospital: lead
• Abbott: collaborator

Study Sites (1)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

lopinavir-ritonavir drug combination; Lopinavir; Ritonavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Limitations and Caveats

Early termination leading to small number of subjects analyzed.

Results Point of Contact

• Title: Laura Clarke-Steffen, PhD, RN
• Organization: Phoenix Children's Hospital

lclarke@choenixchildrens.com

602-933-0234

Study Officials

• Janice Piatt, MD

  Phoenix Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Bill Holt Clinic

Study Record Dates

• First Submitted: September 29, 2008
• First Posted: September 30, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 24, 2014
• Results First Posted: March 24, 2014

Record last verified: 2014-02

Locations

US (1)