HIV Infections
Conditions
Brief summary
This single arm study will assess the pharmacokinetics, safety and activity of saquinavir (Invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination with ritonavir, in HIV-1 infected infants and children between the ages of 4 months and 6 years. Patients will commence treatment with saquinavir 50mg/kg bid plus ritonavir 2.5mg/kg or 3.0mg/kg (dependent on body weight), and a background antiretroviral regimen. If drug exposures are found to be dissimilar to those previously seen in older children and adults, or are associated with toxicities, subsequent dose adjustments will be made. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Interventions
DRUGritonavir
2.5-3.0mg/kg po bid (starting dose) for 48 weeks
50mg/kg po bid (starting dose) for 48 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Months to 6 Years
Healthy volunteers
No
Inclusion criteria
* infants and children, 4 months to \<6 years; * confirmed HIV-1 infection; * patients for whom saquinavir/ritonavir together with \>=2 background ARVs is considered appropriate.
Exclusion criteria
* body weight \>4kg/8.8 pounds; * use of any concomitant medications that may interfere with the pharmacokinetics of saquinavir or ritonavir; * malabsorption, severe chronic diarrhea or vomiting within 28 days of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change In Hematuria, Glycosuria And Proteinuria From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change In Red Blood Cell (RBC) Counts From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Plasma Trough Concentrations (Ctrough) for Saquinavir | Pre-dose at Weeks 8, 12, 24. | Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Saquinavir was normalized to a dose of 50 mg/kg. |
| Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir | Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an Non-nucleoside reverse transcriptase inhibitor [NNRTI] containing regimen). | The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of saquinavir was normalized to a dose of 50 mg/kg. |
| Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | From Baseline (Day 1) till Week 48 and Follow-up (Week 52) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes |
| Change In Hematocrit From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Baseline (Day 1), Week 24 and Week 48 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir | Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen and at Week 24 | The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was normalized to a dose of 50 mg/kg for Saquinavir and100 mg/kg for Ritonavir. |
| Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Ritonavir | Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen). | The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of ritonasvir was normalized to a dose of 100 mg/kg. |
| Change From Baseline in Mean Human Immunodeficiency Virus Viral Load | Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks. | Change from baseline in plasma HIV-1 RNA was derived as Change from baseline = Log10 (HIV-1 RNA at week x) - Log10 (HIV-1 RNA at baseline) |
| Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL | Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks. | The number of participants with HIV-1 RNA results \<400 copies/mL were reported |
| Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL | Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks. | The number of participants with HIV-1 RNA results \<50 copies/mL were reported. |
| Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA ) | From Week 8 till Week 48 | The number of participants experiencing a greater than 1 log drop from baseline (day 1) (log 10 transformed) were reported |
| Number of Participants With Virological Failure | From Week 12 till Week 48 | Virological failure was defined as: viral load \>= 400 copies/mL on two consecutive occasions (missing visits was assumed to be above 400 copies/mL). The number of participants classified as virological failure by Age Group and viral load (≤ 10,000 copies, \>10,000 copies) were presented. |
| Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count | Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation | Change from Baseline in CD4+ lymphocyte count at 24 weeks and 48 weeks were presented by age group. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week 24/48) - (CD4+ count at baseline). A baseline collection was made if there was not already a value available taken within the previous 4 weeks. Baseline was on Day 1. |
| Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count | Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation | Change from baseline in CD8+ lymphocyte count at 24 weeks and 48 weeks were presented by age group. Change from baseline in CD8+ lymphocyte count was derived as follows: Change from baseline = (CD8+ count at week 24/48) - (CD8+ count at baseline). A baseline collection was made if there was not already a value available taken within the previous 4 weeks. Baseline was on Day 1. |
| Plasma Trough Concentrations (Ctrough) for Ritonavir | Pre-dose at Weeks 8, 12, 24 | Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Ritonavir was normalized to a dose of 100 mg/kg. |
Countries
Argentina, Spain, Thailand
Participant flow
Recruitment details
A total of 18 participants were recruited from 8 centers in Argentina (3 centers), Spain (1 center) and Thailand (4 centers). This study was conducted between May 20, 2008 and March 11, 2010.
Pre-assignment details
Participants were human immunodeficiency virus (HIV) infected infants and young children who met the eligibility criteria were stratified into 2 groups - low age (\>= 4 months to \<2 years) and high age group (\>= 2 years to \<6 years). Participants commenced treatment with saquinavir and ritonavir along with background antiretroviral (ARV) regimen.
Participants by arm
| Arm | Count |
|---|---|
| Group A Participants (infants \>= 4 months to \<2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to \< 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight \> 40 kg plus \>= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks. | 5 |
| Group B Participants (children \>= 2 years to \<6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to \< 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight \> 40 kg plus \>= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks. | 13 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failed to return | 1 | 0 |
Baseline characteristics
| Characteristic | Group A | Group B | Total |
|---|---|---|---|
| Age, Continuous | 0.8 years STANDARD_DEVIATION 0.45 | 4.0 years STANDARD_DEVIATION 1.08 | 3.1 years STANDARD_DEVIATION 1.75 |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 11 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 5 | 9 / 13 | 14 / 18 |
| serious Total, serious adverse events | 1 / 5 | 2 / 13 | 3 / 18 |
Outcome results
Primary
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir
The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of saquinavir was normalized to a dose of 50 mg/kg.
Time frame: Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an Non-nucleoside reverse transcriptase inhibitor [NNRTI] containing regimen).
Population: The pharmacokinetics Analysis Population (PKP) comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir | 18.7 h*ug/mL | Standard Deviation 20 |
| Group B | Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir | 38 h*ug/mL | Standard Deviation 18.1 |
Primary
Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Day 1), Week 24 and Week 48
Population: The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Chloride,Change from BL at Wk 24 (n=4,13, 17) | -1 mmol/L | Standard Deviation 2.8 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Triglyceride,Change from BL at Wk 48 (n=4,13, 17) | -0.19 mmol/L | Standard Deviation 0.496 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | BUN,Change from Baseline at Week 24 (n= 3, 13, 16) | -1.5 mmol/L | Standard Deviation 2.78 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Sodium,Change from BL at Wk 48 (n=4,13, 17) | 1 mmol/L | Standard Deviation 2.2 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Calcium,Change from BL at Wk 24 (n=2, 12, 14) | -0.15 mmol/L | Standard Deviation 0.04 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | LDL,Change from Baseline at Week 48 (n= 3, 13, 16) | 0.23 mmol/L | Standard Deviation 0.596 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Sodium,Change from BL at Wk 24 (n=4,13, 17) | 2 mmol/L | Standard Deviation 1.3 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Calcium,Change from BL at Wk 48 (n=2, 12, 14) | -0.16 mmol/L | Standard Deviation 0.09 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Fasting Glucose,Change from BL at Wk 48(n=4,13,17) | -0.07 mmol/L | Standard Deviation 0.857 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Potassium,Change from BL at Wk 48 (n=4,13, 17) | 0.2 mmol/L | Standard Deviation 0.59 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Potassium,Change from BL at Wk 24 (n=4,13, 17) | -0.1 mmol/L | Standard Deviation 0.16 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Phosphate,Change from BL at Wk 48 (n=2, 13, 15) | -0.26 mmol/L | Standard Deviation 0 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | HDL,Change from Baseline at Week 24 (n= 3, 13, 16) | 0.21 mmol/L | Standard Deviation 0.202 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Fasting Glucose,Change from BL at Wk 24(n=4,13,17) | -0.26 mmol/L | Standard Deviation 0.963 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Phosphate,Change from BL at Wk 24 (n=2, 12, 14) | -0.02 mmol/L | Standard Deviation 0.114 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | HDL,Change from Baseline at Week 48 (n= 3, 13, 16) | 0.41 mmol/L | Standard Deviation 0.233 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | LDL,Change from Baseline at Week 24 (n= 3, 13, 16) | 0.21 mmol/L | Standard Deviation 0.237 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Chloride,Change from BL at Wk 48 (n=4,13, 17) | 1 mmol/L | Standard Deviation 1.3 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Triglyceride,Change from BL at Wk 24 (n=4,13, 17) | -0.28 mmol/L | Standard Deviation 0.597 |
| Group A | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | BUN,Change from Baseline at Week 48 (n= 3, 13, 16) | 0.4 mmol/L | Standard Deviation 0.66 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Phosphate,Change from BL at Wk 48 (n=2, 13, 15) | 0.12 mmol/L | Standard Deviation 0.212 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | BUN,Change from Baseline at Week 24 (n= 3, 13, 16) | 1 mmol/L | Standard Deviation 2.2 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | BUN,Change from Baseline at Week 48 (n= 3, 13, 16) | 1.1 mmol/L | Standard Deviation 2 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | LDL,Change from Baseline at Week 24 (n= 3, 13, 16) | 0.21 mmol/L | Standard Deviation 1.389 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | LDL,Change from Baseline at Week 48 (n= 3, 13, 16) | -0.11 mmol/L | Standard Deviation 1.038 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | HDL,Change from Baseline at Week 24 (n= 3, 13, 16) | 0.13 mmol/L | Standard Deviation 0.369 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | HDL,Change from Baseline at Week 48 (n= 3, 13, 16) | 0.17 mmol/L | Standard Deviation 0.387 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Triglyceride,Change from BL at Wk 24 (n=4,13, 17) | -0.19 mmol/L | Standard Deviation 1.376 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Triglyceride,Change from BL at Wk 48 (n=4,13, 17) | -0.15 mmol/L | Standard Deviation 1.558 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Calcium,Change from BL at Wk 24 (n=2, 12, 14) | 0.15 mmol/L | Standard Deviation 0.17 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Calcium,Change from BL at Wk 48 (n=2, 12, 14) | 0.09 mmol/L | Standard Deviation 0.17 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Potassium,Change from BL at Wk 24 (n=4,13, 17) | -0.3 mmol/L | Standard Deviation 0.63 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Potassium,Change from BL at Wk 48 (n=4,13, 17) | -0.2 mmol/L | Standard Deviation 0.54 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Sodium,Change from BL at Wk 24 (n=4,13, 17) | -1 mmol/L | Standard Deviation 2.3 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Sodium,Change from BL at Wk 48 (n=4,13, 17) | -1 mmol/L | Standard Deviation 3.8 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Chloride,Change from BL at Wk 24 (n=4,13, 17) | -2 mmol/L | Standard Deviation 4.2 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Chloride,Change from BL at Wk 48 (n=4,13, 17) | -2 mmol/L | Standard Deviation 3.6 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Phosphate,Change from BL at Wk 24 (n=2, 12, 14) | 0.17 mmol/L | Standard Deviation 0.188 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Fasting Glucose,Change from BL at Wk 24(n=4,13,17) | 0.02 mmol/L | Standard Deviation 1.253 |
| Group B | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Fasting Glucose,Change from BL at Wk 48(n=4,13,17) | 0.14 mmol/L | Standard Deviation 1.537 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | BUN,Change from Baseline at Week 48 (n= 3, 13, 16) | 0.9 mmol/L | Standard Deviation 1.82 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Sodium,Change from BL at Wk 48 (n=4,13, 17) | -0 mmol/L | Standard Deviation 3.5 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Triglyceride,Change from BL at Wk 24 (n=4,13, 17) | -0.21 mmol/L | Standard Deviation 1.22 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Fasting Glucose,Change from BL at Wk 48(n=4,13,17) | 0.09 mmol/L | Standard Deviation 1.385 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Chloride,Change from BL at Wk 24 (n=4,13, 17) | -2 mmol/L | Standard Deviation 3.9 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | HDL,Change from Baseline at Week 48 (n= 3, 13, 16) | 0.21 mmol/L | Standard Deviation 0.37 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Fasting Glucose,Change from BL at Wk 24(n=4,13,17) | -0.05 mmol/L | Standard Deviation 1.169 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Chloride,Change from BL at Wk 48 (n=4,13, 17) | -1 mmol/L | Standard Deviation 3.3 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | HDL,Change from Baseline at Week 24 (n= 3, 13, 16) | 0.15 mmol/L | Standard Deviation 0.34 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | BUN,Change from Baseline at Week 24 (n= 3, 13, 16) | 0.5 mmol/L | Standard Deviation 2.43 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Phosphate,Change from BL at Wk 24 (n=2, 12, 14) | 0.14 mmol/L | Standard Deviation 0.188 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | LDL,Change from Baseline at Week 48 (n= 3, 13, 16) | -0.04 mmol/L | Standard Deviation 0.963 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Potassium,Change from BL at Wk 24 (n=4,13, 17) | -0.2 mmol/L | Standard Deviation 0.56 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Calcium,Change from BL at Wk 48 (n=2, 12, 14) | 0.06 mmol/L | Standard Deviation 0.18 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | LDL,Change from Baseline at Week 24 (n= 3, 13, 16) | 0.21 mmol/L | Standard Deviation 1.245 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Potassium,Change from BL at Wk 48 (n=4,13, 17) | -0.1 mmol/L | Standard Deviation 0.57 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Calcium,Change from BL at Wk 24 (n=2, 12, 14) | 0.11 mmol/L | Standard Deviation 0.19 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Phosphate,Change from BL at Wk 48 (n=2, 13, 15) | 0.07 mmol/L | Standard Deviation 0.237 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Sodium,Change from BL at Wk 24 (n=4,13, 17) | -0 mmol/L | Standard Deviation 2.3 |
| Total | Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline | Triglyceride,Change from BL at Wk 48 (n=4,13, 17) | -0.16 mmol/L | Standard Deviation 1.366 |
Primary
Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Day 1), Week 24 and Week 48
Population: The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | CK, Change from Baseline at Week 24 (n= 3, 3, 16) | 112 U/L | Standard Deviation 112 |
| Group A | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | CK, Change from Baseline at Week 48 (n= 3, 3, 16) | 257 U/L | Standard Deviation 244.8 |
| Group A | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | SGOT, Change from Baseline at Week 24 (n= 4,13,17) | -0 U/L | Standard Deviation 1.5 |
| Group A | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | SGOT, Change from Baseline at Week 48 (n= 4,13,17) | -1 U/L | Standard Deviation 7.8 |
| Group A | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | ALP, Change from Baseline at Week 24 (n=4, 12, 16) | 10 U/L | Standard Deviation 29.8 |
| Group A | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | ALP, Change from Baseline at Week 48 (n=4, 12, 16) | 47 U/L | Standard Deviation 87.6 |
| Group A | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | SGPT, Change from Baseline at Week 24 (n=4,13,17) | -9 U/L | Standard Deviation 15.3 |
| Group A | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | SGPT, Change from Baseline at Week 48 (n=4,13,17) | -2 U/L | Standard Deviation 13.4 |
| Group A | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | GGT, Change from Baseline at Week 24 (n=4, 13, 17) | 5 U/L | Standard Deviation 4.7 |
| Group A | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | GGT, Change from Baseline at Week 48 (n=4, 13, 17) | 5 U/L | Standard Deviation 2.1 |
| Group B | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | GGT, Change from Baseline at Week 24 (n=4, 13, 17) | -7 U/L | Standard Deviation 18.7 |
| Group B | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | CK, Change from Baseline at Week 24 (n= 3, 3, 16) | -12 U/L | Standard Deviation 115.9 |
| Group B | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | ALP, Change from Baseline at Week 48 (n=4, 12, 16) | 36 U/L | Standard Deviation 26.5 |
| Group B | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | ALP, Change from Baseline at Week 24 (n=4, 12, 16) | 26 U/L | Standard Deviation 23.2 |
| Group B | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | CK, Change from Baseline at Week 48 (n= 3, 3, 16) | -7 U/L | Standard Deviation 84 |
| Group B | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | GGT, Change from Baseline at Week 48 (n=4, 13, 17) | -5 U/L | Standard Deviation 18.5 |
| Group B | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | SGPT, Change from Baseline at Week 48 (n=4,13,17) | -3 U/L | Standard Deviation 12.1 |
| Group B | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | SGOT, Change from Baseline at Week 24 (n= 4,13,17) | -0 U/L | Standard Deviation 8.2 |
| Group B | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | SGPT, Change from Baseline at Week 24 (n=4,13,17) | -2 U/L | Standard Deviation 13.6 |
| Group B | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | SGOT, Change from Baseline at Week 48 (n= 4,13,17) | -0 U/L | Standard Deviation 6.9 |
| Total | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | SGPT, Change from Baseline at Week 48 (n=4,13,17) | -3 U/L | Standard Deviation 12 |
| Total | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | SGOT, Change from Baseline at Week 48 (n= 4,13,17) | -0 U/L | Standard Deviation 6.8 |
| Total | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | ALP, Change from Baseline at Week 24 (n=4, 12, 16) | 22 U/L | Standard Deviation 24.9 |
| Total | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | ALP, Change from Baseline at Week 48 (n=4, 12, 16) | 39 U/L | Standard Deviation 45.6 |
| Total | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | GGT, Change from Baseline at Week 24 (n=4, 13, 17) | -4 U/L | Standard Deviation 17.1 |
| Total | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | SGPT, Change from Baseline at Week 24 (n=4,13,17) | -4 U/L | Standard Deviation 13.8 |
| Total | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | CK, Change from Baseline at Week 24 (n= 3, 3, 16) | 11 U/L | Standard Deviation 122.2 |
| Total | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | GGT, Change from Baseline at Week 48 (n=4, 13, 17) | -2 U/L | Standard Deviation 16.7 |
| Total | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | CK, Change from Baseline at Week 48 (n= 3, 3, 16) | 43 U/L | Standard Deviation 158 |
| Total | Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline | SGOT, Change from Baseline at Week 24 (n= 4,13,17) | -0 U/L | Standard Deviation 7.1 |
Primary
Change In Hematocrit From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Day 1), Week 24 and Week 48
Population: The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change In Hematocrit From Baseline | Change from Baseline at Week 24 (n= 4, 13, 17) | 0.01 fraction | Standard Deviation 0.011 |
| Group A | Change In Hematocrit From Baseline | Change from Baseline at Week 48 (n= 4, 13, 17) | 0.03 fraction | Standard Deviation 0.037 |
| Group B | Change In Hematocrit From Baseline | Change from Baseline at Week 24 (n= 4, 13, 17) | -0 fraction | Standard Deviation 0.03 |
| Group B | Change In Hematocrit From Baseline | Change from Baseline at Week 48 (n= 4, 13, 17) | -0.01 fraction | Standard Deviation 0.044 |
| Total | Change In Hematocrit From Baseline | Change from Baseline at Week 24 (n= 4, 13, 17) | -0 fraction | Standard Deviation 0.027 |
| Total | Change In Hematocrit From Baseline | Change from Baseline at Week 48 (n= 4, 13, 17) | 0 fraction | Standard Deviation 0.044 |
Primary
Change In Hematuria, Glycosuria And Proteinuria From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Day 1), Week 24 and Week 48
Population: The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Proteinuria-Change from BL at Wk 48 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Group A | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Hematuria-Change from BL at Wk 24 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Group A | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Glycosuria-Change from BL at Wk 24 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Group A | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Proteinuria-Change from BL at Wk 24 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Group A | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Hematuria-Change from BL at Wk 48 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Group A | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Glycosuria-Change from BL at Wk 48 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Group B | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Hematuria-Change from BL at Wk 48 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Group B | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Proteinuria-Change from BL at Wk 24 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Group B | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Proteinuria-Change from BL at Wk 48 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Group B | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Glycosuria-Change from BL at Wk 48 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Group B | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Glycosuria-Change from BL at Wk 24 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Group B | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Hematuria-Change from BL at Wk 24 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Total | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Proteinuria-Change from BL at Wk 48 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Total | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Hematuria-Change from BL at Wk 24 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Total | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Hematuria-Change from BL at Wk 48 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Total | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Glycosuria-Change from BL at Wk 24 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Total | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Proteinuria-Change from BL at Wk 24 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
| Total | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Glycosuria-Change from BL at Wk 48 (n= 1, 2, 3) | 0 [0 to 4+] | Standard Deviation 0 |
Primary
Change In Hemoglobin, Total Protein And Total Albumin From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Day 1), Week 24 and Week 48
Population: The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Hemoglobin, Change from BL at Wk 24 (n= 4, 13, 17) | -0 g/L | Standard Deviation 3.3 |
| Group A | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Hemoglobin, Change from BL at Wk 48 (n= 4, 13, 17) | 6 g/L | Standard Deviation 11.8 |
| Group A | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Total Protein, Change from BL at Wk 24 (n=4,13,17) | -4 g/L | Standard Deviation 6 |
| Group A | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Total Protein, Change from BL at Wk 48 (n=4,13,17) | -5 g/L | Standard Deviation 5.7 |
| Group A | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Total Albumin, Change from BL at Wk 24 (n=4,13,17) | 0.5 g/L | Standard Deviation 5.41 |
| Group A | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Total Albumin, Change from BL at Wk 48 (n=4,13,17) | 1.3 g/L | Standard Deviation 2.29 |
| Group B | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Total Albumin, Change from BL at Wk 48 (n=4,13,17) | 4 g/L | Standard Deviation 8.7 |
| Group B | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Hemoglobin, Change from BL at Wk 24 (n= 4, 13, 17) | 1 g/L | Standard Deviation 12.1 |
| Group B | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Total Protein, Change from BL at Wk 48 (n=4,13,17) | -0 g/L | Standard Deviation 14.3 |
| Group B | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Total Albumin, Change from BL at Wk 24 (n=4,13,17) | 5 g/L | Standard Deviation 7.68 |
| Group B | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Hemoglobin, Change from BL at Wk 48 (n= 4, 13, 17) | 0 g/L | Standard Deviation 14.4 |
| Group B | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Total Protein, Change from BL at Wk 24 (n=4,13,17) | 2 g/L | Standard Deviation 12.6 |
| Total | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Hemoglobin, Change from BL at Wk 48 (n= 4, 13, 17) | 2 g/L | Standard Deviation 13.7 |
| Total | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Total Protein, Change from BL at Wk 24 (n=4,13,17) | 0 g/L | Standard Deviation 11.5 |
| Total | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Total Albumin, Change from BL at Wk 48 (n=4,13,17) | 3.4 g/L | Standard Deviation 7.7 |
| Total | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Total Protein, Change from BL at Wk 48 (n=4,13,17) | -1 g/L | Standard Deviation 12.8 |
| Total | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Hemoglobin, Change from BL at Wk 24 (n= 4, 13, 17) | 1 g/L | Standard Deviation 10.6 |
| Total | Change In Hemoglobin, Total Protein And Total Albumin From Baseline | Total Albumin, Change from BL at Wk 24 (n=4,13,17) | 4 g/L | Standard Deviation 7.32 |
Primary
Change In Red Blood Cell (RBC) Counts From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Day 1), Week 24 and Week 48
Population: The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change In Red Blood Cell (RBC) Counts From Baseline | RBC,Change from Baseline at Week 24 (n= 4, 13, 17) | -0.18 10*12/L | Standard Deviation 0.227 |
| Group A | Change In Red Blood Cell (RBC) Counts From Baseline | RBC,Change from Baseline at Week 48 (n= 4, 13, 17) | 0.02 10*12/L | Standard Deviation 0.125 |
| Group B | Change In Red Blood Cell (RBC) Counts From Baseline | RBC,Change from Baseline at Week 24 (n= 4, 13, 17) | -0.07 10*12/L | Standard Deviation 0.673 |
| Group B | Change In Red Blood Cell (RBC) Counts From Baseline | RBC,Change from Baseline at Week 48 (n= 4, 13, 17) | -0.16 10*12/L | Standard Deviation 0.74 |
| Total | Change In Red Blood Cell (RBC) Counts From Baseline | RBC,Change from Baseline at Week 24 (n= 4, 13, 17) | -0.1 10*12/L | Standard Deviation 0.593 |
| Total | Change In Red Blood Cell (RBC) Counts From Baseline | RBC,Change from Baseline at Week 48 (n= 4, 13, 17) | -0.12 10*12/L | Standard Deviation 0.648 |
Primary
Change In Total Bilirubin, Creatinine, Uric Acid From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Day 1), Week 24 and Week 48
Population: The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Total Bilirubin-Change from BL at Wk 24(n=4,12,16) | 2 umol/L | Standard Deviation 2.8 |
| Group A | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Total Bilirubin-Change from BL at Wk 48(n=4,12,16) | 1 umol/L | Standard Deviation 1.1 |
| Group A | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Cretainine- Change from BL at Wk 24 (n=4, 13,17) | -2 umol/L | Standard Deviation 6.7 |
| Group A | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Cretainine- Change from BL at Wk 48 (n=4, 13,17) | 3 umol/L | Standard Deviation 10.7 |
| Group A | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Uric acid- Change from BL at Wk 24 (n=4, 13,17) | -27 umol/L | Standard Deviation 54.3 |
| Group A | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Uric acid- Change from BL at Wk 48 (n=3,13,16) | -42 umol/L | Standard Deviation 108.4 |
| Group B | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Uric acid- Change from BL at Wk 48 (n=3,13,16) | 61 umol/L | Standard Deviation 63.5 |
| Group B | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Total Bilirubin-Change from BL at Wk 24(n=4,12,16) | 2 umol/L | Standard Deviation 5.5 |
| Group B | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Cretainine- Change from BL at Wk 48 (n=4, 13,17) | 5 umol/L | Standard Deviation 9.2 |
| Group B | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Uric acid- Change from BL at Wk 24 (n=4, 13,17) | 68 umol/L | Standard Deviation 55.1 |
| Group B | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Total Bilirubin-Change from BL at Wk 48(n=4,12,16) | 2 umol/L | Standard Deviation 6.9 |
| Group B | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Cretainine- Change from BL at Wk 24 (n=4, 13,17) | 3 umol/L | Standard Deviation 10 |
| Total | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Total Bilirubin-Change from BL at Wk 48(n=4,12,16) | 1 umol/L | Standard Deviation 5.9 |
| Total | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Cretainine- Change from BL at Wk 24 (n=4, 13,17) | 2 umol/L | Standard Deviation 9.5 |
| Total | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Uric acid- Change from BL at Wk 48 (n=3,13,16) | 41 umol/L | Standard Deviation 80.6 |
| Total | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Cretainine- Change from BL at Wk 48 (n=4, 13,17) | 5 umol/L | Standard Deviation 9.3 |
| Total | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Total Bilirubin-Change from BL at Wk 24(n=4,12,16) | 2 umol/L | Standard Deviation 4.9 |
| Total | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Uric acid- Change from BL at Wk 24 (n=4, 13,17) | 46 umol/L | Standard Deviation 67.6 |
Primary
Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Day 1), Week 24 and Week 48
Population: The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Neutrophil, Change from BL at Wk 24 (n=2, 2, 4) | -1.4 10*9/L | Standard Deviation 0.33 |
| Group A | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Basophil, Change from BL at Wk 48 (n=4 ,13,17) | -0 10*9/L | Standard Deviation 0.03 |
| Group A | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Platelet, Change from BL at Wk 24 (n= 4,13,17) | -119 10*9/L | Standard Deviation 93.4 |
| Group A | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Monocyte, Change from BL at Wk 48 (n= ,13,17) | -0.21 10*9/L | Standard Deviation 0.179 |
| Group A | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Lymphocyte, Change from BL at Wk 24 (n=2, 2, 4) | -0.9 10*9/L | Standard Deviation 0.3 |
| Group A | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | WBC, Change from BL at Wk 48 (n= 4,13,17) | -2.1 10*9/L | Standard Deviation 1.72 |
| Group A | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Monocyte, Change from BL at Wk 24 (n= ,13,17) | -0.41 10*9/L | Standard Deviation 0.295 |
| Group A | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Lymphocyte, Change from BL at Wk 48 (n= 2, 2, 4) | -1.5 10*9/L | Standard Deviation 0.29 |
| Group A | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Neutrophil, Change from BL at Wk 48 (n= 2, 2, 4) | -1.7 10*9/L | Standard Deviation 1.15 |
| Group A | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Platelet, Change from BL at Wk 48 (n= 4,13,17) | -50 10*9/L | Standard Deviation 130.4 |
| Group A | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Eosinophil, Change from BL at Wk 48 (n= 2, 2, 4) | -0 10*9/L | Standard Deviation 0.2 |
| Group A | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | WBC, Change from BL at Wk 24 (n= 4,13,17) | -3 10*9/L | Standard Deviation 2.31 |
| Group A | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Basophil, Change from BL at Wk 24 (n=4 ,13,17) | -0.02 10*9/L | Standard Deviation 0.028 |
| Group A | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Eosinophil, Change from BL at Wk 24 (n=2, 2, 4) | -0 10*9/L | Standard Deviation 0.2 |
| Group B | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Neutrophil, Change from BL at Wk 24 (n=2, 2, 4) | -2.8 10*9/L | Standard Deviation 1.87 |
| Group B | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | WBC, Change from BL at Wk 24 (n= 4,13,17) | -1 10*9/L | Standard Deviation 4.35 |
| Group B | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | WBC, Change from BL at Wk 48 (n= 4,13,17) | -0.9 10*9/L | Standard Deviation 4.38 |
| Group B | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Platelet, Change from BL at Wk 24 (n= 4,13,17) | 24 10*9/L | Standard Deviation 148.9 |
| Group B | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Platelet, Change from BL at Wk 48 (n= 4,13,17) | -2 10*9/L | Standard Deviation 118.9 |
| Group B | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Basophil, Change from BL at Wk 24 (n=4 ,13,17) | 0 10*9/L | Standard Deviation 0.031 |
| Group B | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Basophil, Change from BL at Wk 48 (n=4 ,13,17) | -0.01 10*9/L | Standard Deviation 0.029 |
| Group B | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Lymphocyte, Change from BL at Wk 24 (n=2, 2, 4) | -1.1 10*9/L | Standard Deviation 1.2 |
| Group B | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Lymphocyte, Change from BL at Wk 48 (n= 2, 2, 4) | -0.7 10*9/L | Standard Deviation 1.05 |
| Group B | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Monocyte, Change from BL at Wk 24 (n= ,13,17) | -0.01 10*9/L | Standard Deviation 0.361 |
| Group B | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Monocyte, Change from BL at Wk 48 (n= ,13,17) | -0.05 10*9/L | Standard Deviation 0.384 |
| Group B | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Neutrophil, Change from BL at Wk 48 (n= 2, 2, 4) | -1.6 10*9/L | Standard Deviation 2.55 |
| Group B | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Eosinophil, Change from BL at Wk 24 (n=2, 2, 4) | -0 10*9/L | Standard Deviation 0.1 |
| Group B | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Eosinophil, Change from BL at Wk 48 (n= 2, 2, 4) | 0 10*9/L | Standard Deviation 1.1 |
| Total | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Eosinophil, Change from BL at Wk 24 (n=2, 2, 4) | -0 10*9/L | Standard Deviation 0.1 |
| Total | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Monocyte, Change from BL at Wk 48 (n= ,13,17) | -0.09 10*9/L | Standard Deviation 0.348 |
| Total | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Basophil, Change from BL at Wk 24 (n=4 ,13,17) | -0.01 10*9/L | Standard Deviation 0.031 |
| Total | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Platelet, Change from BL at Wk 48 (n= 4,13,17) | -13 10*9/L | Standard Deviation 119.3 |
| Total | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Neutrophil, Change from BL at Wk 24 (n=2, 2, 4) | -2.1 10*9/L | Standard Deviation 1.36 |
| Total | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Platelet, Change from BL at Wk 24 (n= 4,13,17) | -9 10*9/L | Standard Deviation 148.9 |
| Total | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | WBC, Change from BL at Wk 24 (n= 4,13,17) | -1.5 10*9/L | Standard Deviation 4 |
| Total | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Neutrophil, Change from BL at Wk 48 (n= 2, 2, 4) | -1.6 10*9/L | Standard Deviation 1.62 |
| Total | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | WBC, Change from BL at Wk 48 (n= 4,13,17) | -1.2 10*9/L | Standard Deviation 3.9 |
| Total | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Lymphocyte, Change from BL at Wk 48 (n= 2, 2, 4) | -1.1 10*9/L | Standard Deviation 0.76 |
| Total | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Lymphocyte, Change from BL at Wk 24 (n=2, 2, 4) | -1 10*9/L | Standard Deviation 0.72 |
| Total | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Eosinophil, Change from BL at Wk 48 (n= 2, 2, 4) | 0 10*9/L | Standard Deviation 0.7 |
| Total | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Monocyte, Change from BL at Wk 24 (n= ,13,17) | -0.11 10*9/L | Standard Deviation 0.379 |
| Total | Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline | Basophil, Change from BL at Wk 48 (n=4 ,13,17) | -0.01 10*9/L | Standard Deviation 0.028 |
Primary
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes
Time frame: From Baseline (Day 1) till Week 48 and Follow-up (Week 52)
Population: The Safety Analysis Population (SAP) comprised all participants who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | Any serious adverse events | 1 participants |
| Group A | Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | Any non-serious adverse events | 5 participants |
| Group B | Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | Any serious adverse events | 2 participants |
| Group B | Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | Any non-serious adverse events | 9 participants |
| Total | Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | Any serious adverse events | 3 participants |
| Total | Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | Any non-serious adverse events | 14 participants |
Primary
Plasma Trough Concentrations (Ctrough) for Saquinavir
Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Saquinavir was normalized to a dose of 50 mg/kg.
Time frame: Pre-dose at Weeks 8, 12, 24.
Population: The pharmacokinetics Analysis Population (PKP) comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Plasma Trough Concentrations (Ctrough) for Saquinavir | 645 ng/mL | Standard Deviation 536 |
| Group B | Plasma Trough Concentrations (Ctrough) for Saquinavir | 1860 ng/mL | Standard Deviation 1060 |
Secondary
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Ritonavir
The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of ritonasvir was normalized to a dose of 100 mg/kg.
Time frame: Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen).
Population: The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Ritonavir | 13.6 h*ug/mL | Standard Deviation 8.18 |
| Group B | Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Ritonavir | 21.8 h*ug/mL | Standard Deviation 11.6 |
Secondary
Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count
Change from Baseline in CD4+ lymphocyte count at 24 weeks and 48 weeks were presented by age group. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week 24/48) - (CD4+ count at baseline). A baseline collection was made if there was not already a value available taken within the previous 4 weeks. Baseline was on Day 1.
Time frame: Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation
Population: The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count | Change from Baseline at Week 24 (n= 3, 12, 15) | 94.90 count/uL | Standard Deviation 643.28 |
| Group A | Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count | Change from Baseline at Week 48 (n= 3, 12, 15) | -50.07 count/uL | Standard Deviation 1013.23 |
| Group B | Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count | Change from Baseline at Week 24 (n= 3, 12, 15) | -34.53 count/uL | Standard Deviation 821.31 |
| Group B | Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count | Change from Baseline at Week 48 (n= 3, 12, 15) | 126.11 count/uL | Standard Deviation 528.49 |
| Total | Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count | Change from Baseline at Week 24 (n= 3, 12, 15) | -8.65 count/uL | Standard Deviation 769.41 |
| Total | Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count | Change from Baseline at Week 48 (n= 3, 12, 15) | 90.87 count/uL | Standard Deviation 609.46 |
Secondary
Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count
Change from baseline in CD8+ lymphocyte count at 24 weeks and 48 weeks were presented by age group. Change from baseline in CD8+ lymphocyte count was derived as follows: Change from baseline = (CD8+ count at week 24/48) - (CD8+ count at baseline). A baseline collection was made if there was not already a value available taken within the previous 4 weeks. Baseline was on Day 1.
Time frame: Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation
Population: The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count | Change from Baseline at Week 24 (n= 3, 12, 15) | -200.49 count/uL | Standard Deviation 161.05 |
| Group A | Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count | Change from Baseline at Week 48 (n= 3, 12, 15) | -92.07 count/uL | Standard Deviation 455.23 |
| Group B | Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count | Change from Baseline at Week 24 (n= 3, 12, 15) | -3.50 count/uL | Standard Deviation 790.86 |
| Group B | Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count | Change from Baseline at Week 48 (n= 3, 12, 15) | 40.52 count/uL | Standard Deviation 641.27 |
| Total | Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count | Change from Baseline at Week 24 (n= 3, 12, 15) | -42.90 count/uL | Standard Deviation 708.37 |
| Total | Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count | Change from Baseline at Week 48 (n= 3, 12, 15) | 14.00 count/uL | Standard Deviation 596.43 |
Secondary
Change From Baseline in Mean Human Immunodeficiency Virus Viral Load
Change from baseline in plasma HIV-1 RNA was derived as Change from baseline = Log10 (HIV-1 RNA at week x) - Log10 (HIV-1 RNA at baseline)
Time frame: Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.
Population: The Safety Analysis Population (SAP) comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change From Baseline in Mean Human Immunodeficiency Virus Viral Load | Change from Baseline at Week 24 (n= 3, 13, 16) | -0.75 log10 copies/mL | Standard Deviation 1.48 |
| Group A | Change From Baseline in Mean Human Immunodeficiency Virus Viral Load | Change from Baseline at Week 48 (n= 3, 13, 16) | -1.27 log10 copies/mL | Standard Deviation 1.01 |
| Group B | Change From Baseline in Mean Human Immunodeficiency Virus Viral Load | Change from Baseline at Week 24 (n= 3, 13, 16) | -1.81 log10 copies/mL | Standard Deviation 1.57 |
| Group B | Change From Baseline in Mean Human Immunodeficiency Virus Viral Load | Change from Baseline at Week 48 (n= 3, 13, 16) | -1.39 log10 copies/mL | Standard Deviation 1.53 |
| Total | Change From Baseline in Mean Human Immunodeficiency Virus Viral Load | Change from Baseline at Week 24 (n= 3, 13, 16) | -1.61 log10 copies/mL | Standard Deviation 1.57 |
| Total | Change From Baseline in Mean Human Immunodeficiency Virus Viral Load | Change from Baseline at Week 48 (n= 3, 13, 16) | -1.36 log10 copies/mL | Standard Deviation 1.42 |
Secondary
Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was normalized to a dose of 50 mg/kg for Saquinavir and100 mg/kg for Ritonavir.
Time frame: Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen and at Week 24
Population: The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir | Saquinavir | 2910 ng/mL | Standard Deviation 3110 |
| Group A | Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir | Ritonavir | 2050 ng/mL | Standard Deviation 1270 |
| Group B | Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir | Saquinavir | 5570 ng/mL | Standard Deviation 2780 |
| Group B | Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir | Ritonavir | 3370 ng/mL | Standard Deviation 2020 |
Secondary
Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA )
The number of participants experiencing a greater than 1 log drop from baseline (day 1) (log 10 transformed) were reported
Time frame: From Week 8 till Week 48
Population: The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA ) | Week 24 (n= 3, 13, 16) | 1 participants |
| Group A | Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA ) | Week 8 (n= 4, 12, 16) | 1 participants |
| Group A | Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA ) | Week 48 (n= 3, 13, 16) | 1 participants |
| Group B | Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA ) | Week 24 (n= 3, 13, 16) | 8 participants |
| Group B | Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA ) | Week 8 (n= 4, 12, 16) | 7 participants |
| Group B | Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA ) | Week 48 (n= 3, 13, 16) | 7 participants |
| Total | Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA ) | Week 8 (n= 4, 12, 16) | 8 participants |
| Total | Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA ) | Week 48 (n= 3, 13, 16) | 8 participants |
| Total | Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA ) | Week 24 (n= 3, 13, 16) | 9 participants |
Secondary
Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL
The number of participants with HIV-1 RNA results \<400 copies/mL were reported
Time frame: Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.
Population: The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL | Week 24 (n= 3, 13, 16) | 2 participants |
| Group A | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL | Baseline (n= 5, 13, 18) | 1 participants |
| Group A | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL | Week 48 (n= 3, 13, 16) | 2 participants |
| Group B | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL | Week 24 (n= 3, 13, 16) | 13 participants |
| Group B | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL | Baseline (n= 5, 13, 18) | 5 participants |
| Group B | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL | Week 48 (n= 3, 13, 16) | 11 participants |
| Total | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL | Baseline (n= 5, 13, 18) | 6 participants |
| Total | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL | Week 48 (n= 3, 13, 16) | 13 participants |
| Total | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL | Week 24 (n= 3, 13, 16) | 15 participants |
Secondary
Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL
The number of participants with HIV-1 RNA results \<50 copies/mL were reported.
Time frame: Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.
Population: The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL | Week 24 (n= 3, 13, 16) | 2 participants |
| Group A | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL | Baseline (n= 5, 13, 18) | 0 participants |
| Group A | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL | Week 48 (n= 3, 13, 16) | 2 participants |
| Group B | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL | Week 24 (n= 3, 13, 16) | 11 participants |
| Group B | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL | Baseline (n= 5, 13, 18) | 4 participants |
| Group B | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL | Week 48 (n= 3, 13, 16) | 9 participants |
| Total | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL | Baseline (n= 5, 13, 18) | 4 participants |
| Total | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL | Week 48 (n= 3, 13, 16) | 11 participants |
| Total | Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL | Week 24 (n= 3, 13, 16) | 13 participants |
Secondary
Number of Participants With Virological Failure
Virological failure was defined as: viral load \>= 400 copies/mL on two consecutive occasions (missing visits was assumed to be above 400 copies/mL). The number of participants classified as virological failure by Age Group and viral load (≤ 10,000 copies, \>10,000 copies) were presented.
Time frame: From Week 12 till Week 48
Population: The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Number of Participants With Virological Failure | HIV-RNA <= 10,000 copies/mL at Wk 12 (n= 3, 6, 9) | 1 participants |
| Group A | Number of Participants With Virological Failure | HIV-RNA >10,000 copies/mL at Week 48 (n= 2, 7, 9) | 1 participants |
| Group A | Number of Participants With Virological Failure | HIV-RNA <= 10,000 copies/mL at Wk 48 (n= 3, 6, 9) | 2 participants |
| Group A | Number of Participants With Virological Failure | HIV-RNA <= 10,000 copies/mL at Wk 24 (n= 3, 6, 9) | 1 participants |
| Group A | Number of Participants With Virological Failure | VF at Week 12 (n= 5, 13, 18) | 2 participants |
| Group A | Number of Participants With Virological Failure | HIV-RNA >10,000 copies/mL at Week 24 (n= 2, 7, 9) | 1 participants |
| Group A | Number of Participants With Virological Failure | VF at Week 48 (n= 5, 13, 18) | 3 participants |
| Group A | Number of Participants With Virological Failure | VF at Week 24 (n= 5, 13, 18) | 2 participants |
| Group A | Number of Participants With Virological Failure | HIV-RNA >10,000 copies/mL at Week 12 (n= 2, 7, 9) | 1 participants |
| Group B | Number of Participants With Virological Failure | HIV-RNA <= 10,000 copies/mL at Wk 24 (n= 3, 6, 9) | 0 participants |
| Group B | Number of Participants With Virological Failure | VF at Week 12 (n= 5, 13, 18) | 1 participants |
| Group B | Number of Participants With Virological Failure | VF at Week 24 (n= 5, 13, 18) | 0 participants |
| Group B | Number of Participants With Virological Failure | VF at Week 48 (n= 5, 13, 18) | 1 participants |
| Group B | Number of Participants With Virological Failure | HIV-RNA <= 10,000 copies/mL at Wk 12 (n= 3, 6, 9) | 0 participants |
| Group B | Number of Participants With Virological Failure | HIV-RNA <= 10,000 copies/mL at Wk 48 (n= 3, 6, 9) | 0 participants |
| Group B | Number of Participants With Virological Failure | HIV-RNA >10,000 copies/mL at Week 12 (n= 2, 7, 9) | 1 participants |
| Group B | Number of Participants With Virological Failure | HIV-RNA >10,000 copies/mL at Week 24 (n= 2, 7, 9) | 0 participants |
| Group B | Number of Participants With Virological Failure | HIV-RNA >10,000 copies/mL at Week 48 (n= 2, 7, 9) | 1 participants |
| Total | Number of Participants With Virological Failure | VF at Week 48 (n= 5, 13, 18) | 4 participants |
| Total | Number of Participants With Virological Failure | VF at Week 12 (n= 5, 13, 18) | 3 participants |
| Total | Number of Participants With Virological Failure | HIV-RNA >10,000 copies/mL at Week 12 (n= 2, 7, 9) | 2 participants |
| Total | Number of Participants With Virological Failure | VF at Week 24 (n= 5, 13, 18) | 2 participants |
| Total | Number of Participants With Virological Failure | HIV-RNA >10,000 copies/mL at Week 48 (n= 2, 7, 9) | 2 participants |
| Total | Number of Participants With Virological Failure | HIV-RNA <= 10,000 copies/mL at Wk 24 (n= 3, 6, 9) | 1 participants |
| Total | Number of Participants With Virological Failure | HIV-RNA <= 10,000 copies/mL at Wk 12 (n= 3, 6, 9) | 1 participants |
| Total | Number of Participants With Virological Failure | HIV-RNA >10,000 copies/mL at Week 24 (n= 2, 7, 9) | 1 participants |
| Total | Number of Participants With Virological Failure | HIV-RNA <= 10,000 copies/mL at Wk 48 (n= 3, 6, 9) | 2 participants |
Secondary
Plasma Trough Concentrations (Ctrough) for Ritonavir
Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Ritonavir was normalized to a dose of 100 mg/kg.
Time frame: Pre-dose at Weeks 8, 12, 24
Population: The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Plasma Trough Concentrations (Ctrough) for Ritonavir | 577 ng/mL | Standard Deviation 366 |
| Group B | Plasma Trough Concentrations (Ctrough) for Ritonavir | 995 ng/mL | Standard Deviation 548 |