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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose Kaletra tablets | Drug | Lopinavir/Ritonavir tablets 100mg/25mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | 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. | Baseline, 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janice Piatt, MD | Phoenix Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Kaletra | Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose Kaletra | Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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%. | All participants were analyzed. | Posted | Number | participants | Baseline, 4 weeks, 12 weeks, 26 weeks |
|
Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose Kaletra | Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pain due to previously scheduled orthopedic surgery |
Early termination leading to small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Clarke-Steffen, PhD, RN | Phoenix Children's Hospital | 602-933-0234 | lclarke@choenixchildrens.com |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C558899 | lopinavir-ritonavir drug combination |
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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 |
| Symptoms Across All Patients | 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. | Baseline, 1 month, 3 months, 6 months |
| Parent Satisfaction | 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. | Baseline, 4 week, 12 weeks and 24 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Primary | 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. | All participants were analyzed | Posted | Median | Standard Deviation | ng/ml | Baseline |
|
|
|
| Primary | 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. | All participants were analyzed | Posted | Median | Standard Deviation | hr*ng/ml | Baseline |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | ratio | Baseline, week 4 |
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|
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| Secondary | Patient Satisfaction | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 month |
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| Secondary | Symptoms Across All Patients | 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. | All participants analyzed | Posted | Mean | Standard Deviation | numer of symptoms | Baseline, 1 month, 3 months, 6 months |
|
|
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| Primary | Viral Load (VL) | Number of participants who maintained their Viral load undetectable (< 20 copies/ml) for the duration of the study | All subjects in study were analyzed | Posted | Number | participants | Baseline, Week 4, Week 12 and Week 24 |
|
|
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| Primary | 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 | All participants were analyzed | Posted | Median | Standard Deviation | ng/ml | 4 weeks |
|
|
|
| Primary | 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. | All participants were analyzed | Posted | Median | Standard Deviation | hr*ng/ml | 4 weeks |
|
|
|
| Secondary | Parent Satisfaction | 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. | Posted | Mean | Standard Deviation | Score on a survey | Baseline, 4 week, 12 weeks and 24 weeks |
|
|
|
|
| 0 |
| 8 |
| 8 |
| 8 |
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| Throat Pain | General disorders | Systematic Assessment |
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| fever | General disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| anorexia | Gastrointestinal disorders | Systematic Assessment |
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| ear pain | Ear and labyrinth disorders | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | Systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| headache | General disorders | Systematic Assessment |
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| nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| difficulty breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | leg cramps or leg pain |
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| leg fatigue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Increased MCV | Investigations | Systematic Assessment |
|
| Increased Cholesterol | Investigations | Systematic Assessment |
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| Increased Triglycerides | Investigations | Systematic Assessment |
|
| increased amylase | Investigations | Systematic Assessment |
|
| Increased Monocytes | Investigations | Systematic Assessment |
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| Increased WBC | Investigations | Systematic Assessment |
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| decreased RBC | Investigations | Systematic Assessment |
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| decreased plt | Investigations | Systematic Assessment |
|
| Increased eosinophils | Investigations | Systematic Assessment |
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| decreased neutrophil percent | Investigations | Systematic Assessment |
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| decreased ANC | Investigations | Systematic Assessment |
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| Increased lymphocyte percent | Investigations | Systematic Assessment |
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| increased HCT | Investigations | Systematic Assessment |
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| decreased CO2 | Investigations | Systematic Assessment |
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| increased CO2 | Investigations | Systematic Assessment |
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| Increased Alk Phos | Investigations | Systematic Assessment |
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| Decreased Na+ | Investigations | Systematic Assessment |
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| Increased K+ | Investigations | Systematic Assessment |
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| decreased K+ | Investigations | Systematic Assessment |
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| Increased Creatinine | Investigations | Systematic Assessment |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D013844 |
| Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
|
| Symptoms for all subjects at 24 weeks |
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