Trial Outcomes & Findings for Comparison of Liquid Kaletra and Low Dose Kaletra Tablets (NCT NCT00762320)
NCT ID: NCT00762320
Last Updated: 2014-03-24
Results Overview
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%.
COMPLETED
NA
8 participants
Baseline, 4 weeks, 12 weeks, 26 weeks
2014-03-24
Participant Flow
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
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Liquid Kaletra and Low Dose Kaletra Tablets
Baseline characteristics by cohort
| Measure |
Low Dose Kaletra
n=8 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
7.18 years
STANDARD_DEVIATION 1.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 12 weeks, 26 weeksPopulation: All participants were analyzed.
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%.
Outcome measures
| Measure |
Low Dose Kaletra
n=8 Participants
Patients receiving Low Dose Kaletra Tablets
|
Low Dose Kaletra Week 4 Visit
Patient Satisfaction Score at Week 4 visit
|
|---|---|---|
|
Absolute CD4 and CD4 %
|
8 participants
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: All participants were analyzed
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.
Outcome measures
| Measure |
Low Dose Kaletra
n=8 Participants
Patients receiving Low Dose Kaletra Tablets
|
Low Dose Kaletra Week 4 Visit
Patient Satisfaction Score at Week 4 visit
|
|---|---|---|
|
Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid
Cmax Lpv
|
9742 ng/ml
Standard Deviation 2533.9
|
—
|
|
Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid
Cmax Rtv
|
637.0 ng/ml
Standard Deviation 357.5
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: All participants were analyzed
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.
Outcome measures
| Measure |
Low Dose Kaletra
n=8 Participants
Patients receiving Low Dose Kaletra Tablets
|
Low Dose Kaletra Week 4 Visit
Patient Satisfaction Score at Week 4 visit
|
|---|---|---|
|
Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra
Lpv AUC at baseline
|
90651 hr*ng/ml
Standard Deviation 30346.4
|
—
|
|
Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra
Rtv AUC at baseline
|
3701.2 hr*ng/ml
Standard Deviation 2088.0
|
—
|
PRIMARY outcome
Timeframe: Baseline, week 4Ratio 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.
Outcome measures
| Measure |
Low Dose Kaletra
n=8 Participants
Patients receiving Low Dose Kaletra Tablets
|
Low Dose Kaletra Week 4 Visit
Patient Satisfaction Score at Week 4 visit
|
|---|---|---|
|
Lopinavir AUC Ratio of Baseline:Week 4
|
1.01 ratio
Standard Deviation .36
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 12 and Week 24Population: All subjects in study were analyzed
Number of participants who maintained their Viral load undetectable (\< 20 copies/ml) for the duration of the study
Outcome measures
| Measure |
Low Dose Kaletra
n=8 Participants
Patients receiving Low Dose Kaletra Tablets
|
Low Dose Kaletra Week 4 Visit
Patient Satisfaction Score at Week 4 visit
|
|---|---|---|
|
Viral Load (VL)
|
8 participants
|
—
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: All participants were analyzed
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
Outcome measures
| Measure |
Low Dose Kaletra
n=8 Participants
Patients receiving Low Dose Kaletra Tablets
|
Low Dose Kaletra Week 4 Visit
Patient Satisfaction Score at Week 4 visit
|
|---|---|---|
|
Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks
Lpv Cmax at 4 weeks
|
11143 ng/ml
Standard Deviation 2839.5
|
—
|
|
Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks
Rtv Cmax at 4 weeks
|
912.1 ng/ml
Standard Deviation 588.9
|
—
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: All participants were analyzed
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.
Outcome measures
| Measure |
Low Dose Kaletra
n=8 Participants
Patients receiving Low Dose Kaletra Tablets
|
Low Dose Kaletra Week 4 Visit
Patient Satisfaction Score at Week 4 visit
|
|---|---|---|
|
Lopinavir and Ritonavir AUC on Low Dose Tablet
Lpv AUC at 4 weeks
|
85670 hr*ng/ml
Standard Deviation 25184.5
|
—
|
|
Lopinavir and Ritonavir AUC on Low Dose Tablet
Rtv AUC at 4 weeks
|
4876.1 hr*ng/ml
Standard Deviation 2541.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 monthPopulation: 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.
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.
Outcome measures
| Measure |
Low Dose Kaletra
n=5 Participants
Patients receiving Low Dose Kaletra Tablets
|
Low Dose Kaletra Week 4 Visit
n=5 Participants
Patient Satisfaction Score at Week 4 visit
|
|---|---|---|
|
Patient Satisfaction
|
20.2 units on a scale
Standard Deviation 7.76
|
21.8 units on a scale
Standard Deviation 6.02
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 monthsPopulation: All participants analyzed
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.
Outcome measures
| Measure |
Low Dose Kaletra
n=8 Participants
Patients receiving Low Dose Kaletra Tablets
|
Low Dose Kaletra Week 4 Visit
Patient Satisfaction Score at Week 4 visit
|
|---|---|---|
|
Symptoms Across All Patients
Symptoms for all subjects at Baseline
|
20.20 numer of symptoms
Standard Deviation 7.76
|
—
|
|
Symptoms Across All Patients
Symptoms for all subjects at 4 Weeks
|
21.80 numer of symptoms
Standard Deviation 6.02
|
—
|
|
Symptoms Across All Patients
Symptoms for all subjects at 12 Weeks
|
26.40 numer of symptoms
Standard Deviation 2.30
|
—
|
|
Symptoms Across All Patients
Symptoms for all subjects at 24 weeks
|
26.60 numer of symptoms
Standard Deviation 3.21
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 week, 12 weeks and 24 weeksParent 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.
Outcome measures
| Measure |
Low Dose Kaletra
n=8 Participants
Patients receiving Low Dose Kaletra Tablets
|
Low Dose Kaletra Week 4 Visit
n=8 Participants
Patient Satisfaction Score at Week 4 visit
|
|---|---|---|
|
Parent Satisfaction
|
26.75 Score on a survey
Standard Deviation 3.92
|
28.38 Score on a survey
Standard Deviation 3.02
|
Adverse Events
Low Dose Kaletra
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose Kaletra
n=8 participants at risk
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
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Pain
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
General disorders
Throat Pain
|
12.5%
1/8 • Number of events 4 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
General disorders
fever
|
12.5%
1/8 • Number of events 3 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
4/8 • Number of events 8 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Gastrointestinal disorders
anorexia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Ear and labyrinth disorders
ear pain
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Gastrointestinal disorders
vomiting
|
50.0%
4/8 • Number of events 4 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Gastrointestinal disorders
nausea
|
25.0%
2/8 • Number of events 3 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
General disorders
headache
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
37.5%
3/8 • Number of events 8 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Respiratory, thoracic and mediastinal disorders
difficulty breathing
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Gastrointestinal disorders
diarrhea
|
37.5%
3/8 • Number of events 6 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
25.0%
2/8 • Number of events 7 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Musculoskeletal and connective tissue disorders
leg fatigue
|
12.5%
1/8 • Number of events 2 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
Increased MCV
|
87.5%
7/8 • Number of events 23 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
Increased Cholesterol
|
87.5%
7/8 • Number of events 24 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
Increased Triglycerides
|
25.0%
2/8 • Number of events 3 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
increased amylase
|
62.5%
5/8 • Number of events 8 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
Increased Monocytes
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
Increased WBC
|
25.0%
2/8 • Number of events 2 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
decreased RBC
|
50.0%
4/8 • Number of events 8 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
decreased plt
|
25.0%
2/8 • Number of events 2 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
Increased eosinophils
|
50.0%
4/8 • Number of events 4 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
decreased neutrophil percent
|
37.5%
3/8 • Number of events 7 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
decreased ANC
|
25.0%
2/8 • Number of events 4 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
Increased lymphocyte percent
|
37.5%
3/8 • Number of events 8 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
increased HCT
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
decreased CO2
|
25.0%
2/8 • Number of events 2 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
increased CO2
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
Increased Alk Phos
|
12.5%
1/8 • Number of events 2 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
Decreased Na+
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
Increased K+
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
decreased K+
|
12.5%
1/8 • Number of events 1 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
|
Investigations
Increased Creatinine
|
12.5%
1/8 • Number of events 2 • Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
|
Additional Information
Laura Clarke-Steffen, PhD, RN
Phoenix Children's Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place