Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT00762320
Status:
COMPLETED
Last Update Posted:
2014-03-24
First Post:
2008-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Liquid Kaletra and Low Dose Kaletra Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}, {'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lclarke@choenixchildrens.com', 'phone': '602-933-0234', 'title': 'Laura Clarke-Steffen, PhD, RN', 'organization': "Phoenix Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination leading to small number of subjects analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra', 'eventGroups': [{'id': 'EG000', 'title': 'Low Dose Kaletra', 'description': 'Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra\n\nLow dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain', 'notes': 'Pain due to previously scheduled orthopedic surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Throat Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'difficulty breathing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'leg pain', 'notes': 'leg cramps or leg pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'leg fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased MCV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 23, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Cholesterol', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 24, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Triglycerides', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased amylase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Monocytes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased WBC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'decreased RBC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'decreased plt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased eosinophils', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'decreased neutrophil percent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'decreased ANC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased lymphocyte percent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased HCT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'decreased CO2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased CO2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Alk Phos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Na+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased K+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'decreased K+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute CD4 and CD4 %', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Kaletra', 'description': 'Patients receiving Low Dose Kaletra Tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 4 weeks, 12 weeks, 26 weeks', 'description': "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%.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed.'}, {'type': 'PRIMARY', 'title': 'Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Kaletra', 'description': 'Patients receiving Low Dose Kaletra Tablets'}], 'classes': [{'title': 'Cmax Lpv', 'categories': [{'measurements': [{'value': '9742', 'spread': '2533.9', 'groupId': 'OG000'}]}]}, {'title': 'Cmax Rtv', 'categories': [{'measurements': [{'value': '637.0', 'spread': '357.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': '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.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed'}, {'type': 'PRIMARY', 'title': 'Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Kaletra', 'description': 'Patients receiving Low Dose Kaletra Tablets'}], 'classes': [{'title': 'Lpv AUC at baseline', 'categories': [{'measurements': [{'value': '90651', 'spread': '30346.4', 'groupId': 'OG000'}]}]}, {'title': 'Rtv AUC at baseline', 'categories': [{'measurements': [{'value': '3701.2', 'spread': '2088.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': '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.', 'unitOfMeasure': 'hr*ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed'}, {'type': 'PRIMARY', 'title': 'Lopinavir AUC Ratio of Baseline:Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Kaletra', 'description': 'Patients receiving Low Dose Kaletra Tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 4', 'description': '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.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Kaletra Baseline Visit', 'description': 'Patient satisfaction score at baseline visit'}, {'id': 'OG001', 'title': 'Low Dose Kaletra Week 4 Visit', 'description': 'Patient Satisfaction Score at Week 4 visit'}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '21.8', 'spread': '6.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=.004', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'df=4', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 month', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients had to be able to read and write to complete the patient satisfaction questionnaire, so an arbitrary age of 7 was selected and patients under the age of 7 did not complete the patient satisfaction questionnaire. All 5 of the patients over the age of 5 completed the questionnaire and were analyzed.'}, {'type': 'SECONDARY', 'title': 'Symptoms Across All Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Kaletra', 'description': 'Patients receiving Low Dose Kaletra'}], 'classes': [{'title': 'Symptoms for all subjects at Baseline', 'categories': [{'measurements': [{'value': '20.20', 'spread': '7.76', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms for all subjects at 4 Weeks', 'categories': [{'measurements': [{'value': '21.80', 'spread': '6.02', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms for all subjects at 12 Weeks', 'categories': [{'measurements': [{'value': '26.40', 'spread': '2.30', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms for all subjects at 24 weeks', 'categories': [{'measurements': [{'value': '26.60', 'spread': '3.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months', 'description': '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.', 'unitOfMeasure': 'numer of symptoms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants analyzed'}, {'type': 'PRIMARY', 'title': 'Viral Load (VL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Kaletra', 'description': 'Patients receiving Low Dose Kaletra Tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 4, Week 12 and Week 24', 'description': 'Number of participants who maintained their Viral load undetectable (\\< 20 copies/ml) for the duration of the study', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in study were analyzed'}, {'type': 'PRIMARY', 'title': 'Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Kaletra', 'description': 'Patients receiving Low Dose Kaletra Tablets'}], 'classes': [{'title': 'Lpv Cmax at 4 weeks', 'categories': [{'measurements': [{'value': '11143', 'spread': '2839.5', 'groupId': 'OG000'}]}]}, {'title': 'Rtv Cmax at 4 weeks', 'categories': [{'measurements': [{'value': '912.1', 'spread': '588.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': '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', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed'}, {'type': 'PRIMARY', 'title': 'Lopinavir and Ritonavir AUC on Low Dose Tablet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Kaletra', 'description': 'Patients receiving Low Dose Kaletra Tablets'}], 'classes': [{'title': 'Lpv AUC at 4 weeks', 'categories': [{'measurements': [{'value': '85670', 'spread': '25184.5', 'groupId': 'OG000'}]}]}, {'title': 'Rtv AUC at 4 weeks', 'categories': [{'measurements': [{'value': '4876.1', 'spread': '2541.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': '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.', 'unitOfMeasure': 'hr*ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed'}, {'type': 'SECONDARY', 'title': 'Parent Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Kaletra Baseline', 'description': 'Patients receiving Low Dose Kaletra at baseline'}, {'id': 'OG001', 'title': 'Low Dose Kaletra Week 4', 'description': 'Patients Receiving Low Dose Kaletra at Week 4'}], 'classes': [{'categories': [{'measurements': [{'value': '26.75', 'spread': '3.92', 'groupId': 'OG000'}, {'value': '28.38', 'spread': '3.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'df=7', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 week, 12 weeks and 24 weeks', 'description': "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.", 'unitOfMeasure': 'Score on a survey', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose Kaletra', 'description': 'Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra\n\nLow dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients weighing 15kg and able to swallow pills, currently taking liquid lpv/rtv were recruited from an outpatient pediatric HIV clinic from 4/1/2009 through 1/12/11'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose Kaletra', 'description': 'Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra\n\nLow dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.18', 'spread': '1.79', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-05', 'studyFirstSubmitDate': '2008-09-29', 'resultsFirstSubmitDate': '2013-11-14', 'studyFirstSubmitQcDate': '2008-09-29', 'lastUpdatePostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-05', 'studyFirstPostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute CD4 and CD4 %', 'timeFrame': 'Baseline, 4 weeks, 12 weeks, 26 weeks', 'description': "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%."}, {'measure': 'Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Lopinavir AUC Ratio of Baseline:Week 4', 'timeFrame': 'Baseline, week 4', 'description': '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.'}, {'measure': 'Viral Load (VL)', 'timeFrame': 'Baseline, Week 4, Week 12 and Week 24', 'description': 'Number of participants who maintained their Viral load undetectable (\\< 20 copies/ml) for the duration of the study'}, {'measure': 'Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks', 'timeFrame': '4 weeks', 'description': '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'}, {'measure': 'Lopinavir and Ritonavir AUC on Low Dose Tablet', 'timeFrame': '4 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': 'Baseline, 1 month', 'description': '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.'}, {'measure': 'Symptoms Across All Patients', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months', 'description': '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.'}, {'measure': 'Parent Satisfaction', 'timeFrame': 'Baseline, 4 week, 12 weeks and 24 weeks', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'Kaletra', 'treatment Experienced'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV+ children aged 3-18.\n* Baseline treatment includes liquid Kaletra\n* currently on a stable (on same regimen \\> 3 months, Viral Load\\< 5,000), Highly Active Antiretroviral Therapy (HAART) regimen\n* able to take pills or willing to undergo pill training prior to enrollment\n* weight must be greater than or equal to 15kg\n\nExclusion Criteria:\n\n* Unable to swallow pills\n* Concomitant treatment with Rifampin or St. John's Wort which have been shown to decrease plasma concentrations of lopinavir.\n* 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\n* Baseline treatment does NOT include Kaletra"}, 'identificationModule': {'nctId': 'NCT00762320', 'briefTitle': 'Comparison of Liquid Kaletra and Low Dose Kaletra Tablets', 'organization': {'class': 'OTHER', 'fullName': "Phoenix Children's Hospital"}, 'officialTitle': 'Comparison of Liquid Kaletra and Low Dose Kaletra Tablets in HIV-Positive Children', 'orgStudyIdInfo': {'id': '08-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose Kaletra tablets', 'description': '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)', 'interventionNames': ['Drug: Low dose Kaletra tablets']}], 'interventions': [{'name': 'Low dose Kaletra tablets', 'type': 'DRUG', 'otherNames': ['lopinavir/ritonavir 100mg/25mg'], 'description': 'Lopinavir/Ritonavir tablets 100mg/25mg', 'armGroupLabels': ['Low dose Kaletra tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Janice Piatt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Phoenix Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Phoenix Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director, Bill Holt Clinic', 'investigatorFullName': 'Janice Piatt', 'investigatorAffiliation': "Phoenix Children's Hospital"}}}}