Comparison of Liquid Kaletra and Low Dose Kaletra Tablets
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00762320|
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : March 24, 2014
Last Update Posted : March 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Low dose Kaletra tablets||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
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
|United States, Arizona|
|Phoenix Children's Hospital|
|Phoenix, Arizona, United States, 85016|
|Principal Investigator:||Janice Piatt, MD||Phoenix Children's Hospital|