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A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.

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ClinicalTrials.gov Identifier: NCT00623597
Recruitment Status : Completed
First Posted : February 26, 2008
Results First Posted : January 14, 2016
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: ritonavir
Drug: saquinavir [Invirase]
Enrollment 18
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.
Arm/Group Title Group A Group B
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 5 13
Completed 4 13
Not Completed 1 0
Reason Not Completed
Failed to return             1             0
Arm/Group Title Group A Group B Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 5 13 18
Hide Baseline Analysis Population Description
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
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 13 participants 18 participants
0.8  (0.45) 4.0  (1.08) 3.1  (1.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 13 participants 18 participants
Female
3
  60.0%
8
  61.5%
11
  61.1%
Male
2
  40.0%
5
  38.5%
7
  38.9%
1.Primary Outcome
Title Plasma Trough Concentrations (Ctrough) for Saquinavir
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 5 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
645  (536) 1860  (1060)
2.Primary Outcome
Title Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 5 13
Mean (Standard Deviation)
Unit of Measure: h*ug/mL
18.7  (20.0) 38  (18.1)
3.Primary Outcome
Title Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Measure Type: Number
Unit of Measure: participants
Any serious adverse events 1 2 3
Any non-serious adverse events 5 9 14
4.Primary Outcome
Title Change In Hematocrit From Baseline
Hide Description Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline (Day 1), Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Mean (Standard Deviation)
Unit of Measure: fraction
Change from Baseline at Week 24 (n= 4, 13, 17) 0.01  (0.011) -0  (0.03) -0  (0.027)
Change from Baseline at Week 48 (n= 4, 13, 17) 0.03  (0.037) -0.01  (0.044) 0  (0.044)
5.Primary Outcome
Title Change In Hemoglobin, Total Protein And Total Albumin From Baseline
Hide Description Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline (Day 1), Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Mean (Standard Deviation)
Unit of Measure: g/L
Hemoglobin, Change from BL at Wk 24 (n= 4, 13, 17) -0  (3.3) 1  (12.1) 1  (10.6)
Hemoglobin, Change from BL at Wk 48 (n= 4, 13, 17) 6  (11.8) 0  (14.4) 2  (13.7)
Total Protein, Change from BL at Wk 24 (n=4,13,17) -4  (6.0) 2  (12.6) 0  (11.5)
Total Protein, Change from BL at Wk 48 (n=4,13,17) -5  (5.7) -0  (14.3) -1  (12.8)
Total Albumin, Change from BL at Wk 24 (n=4,13,17) 0.5  (5.41) 5  (7.68) 4  (7.32)
Total Albumin, Change from BL at Wk 48 (n=4,13,17) 1.3  (2.29) 4  (8.7) 3.4  (7.7)
6.Primary Outcome
Title Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline
Hide Description Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline (Day 1), Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Mean (Standard Deviation)
Unit of Measure: 10*9/L
WBC, Change from BL at Wk 24 (n= 4,13,17) -3  (2.31) -1  (4.35) -1.5  (4.0)
WBC, Change from BL at Wk 48 (n= 4,13,17) -2.1  (1.72) -0.9  (4.38) -1.2  (3.9)
Platelet, Change from BL at Wk 24 (n= 4,13,17) -119  (93.4) 24  (148.9) -9  (148.9)
Platelet, Change from BL at Wk 48 (n= 4,13,17) -50  (130.4) -2  (118.9) -13  (119.3)
Basophil, Change from BL at Wk 24 (n=4 ,13,17) -0.02  (0.028) 0  (0.031) -0.01  (0.031)
Basophil, Change from BL at Wk 48 (n=4 ,13,17) -0  (0.03) -0.01  (0.029) -0.01  (0.028)
Lymphocyte, Change from BL at Wk 24 (n=2, 2, 4) -0.9  (0.3) -1.1  (1.20) -1  (0.72)
Lymphocyte, Change from BL at Wk 48 (n= 2, 2, 4) -1.5  (0.29) -0.7  (1.05) -1.1  (0.76)
Monocyte, Change from BL at Wk 24 (n= ,13,17) -0.41  (0.295) -0.01  (0.361) -0.11  (0.379)
Monocyte, Change from BL at Wk 48 (n= ,13,17) -0.21  (0.179) -0.05  (0.384) -0.09  (0.348)
Neutrophil, Change from BL at Wk 24 (n=2, 2, 4) -1.4  (0.33) -2.8  (1.87) -2.1  (1.36)
Neutrophil, Change from BL at Wk 48 (n= 2, 2, 4) -1.7  (1.15) -1.6  (2.55) -1.6  (1.62)
Eosinophil, Change from BL at Wk 24 (n=2, 2, 4) -0  (0.2) -0  (0.1) -0  (0.1)
Eosinophil, Change from BL at Wk 48 (n= 2, 2, 4) -0  (0.2) 0  (1.1) 0  (0.7)
7.Primary Outcome
Title Change In Red Blood Cell (RBC) Counts From Baseline
Hide Description Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline (Day 1), Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Mean (Standard Deviation)
Unit of Measure: 10*12/L
RBC,Change from Baseline at Week 24 (n= 4, 13, 17) -0.18  (0.227) -0.07  (0.673) -0.1  (0.593)
RBC,Change from Baseline at Week 48 (n= 4, 13, 17) 0.02  (0.125) -0.16  (0.74) -0.12  (0.648)
8.Primary Outcome
Title 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
Hide Description Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline (Day 1), Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Mean (Standard Deviation)
Unit of Measure: U/L
CK, Change from Baseline at Week 24 (n= 3, 3, 16) 112  (112.0) -12  (115.9) 11  (122.2)
CK, Change from Baseline at Week 48 (n= 3, 3, 16) 257  (244.8) -7  (84) 43  (158)
SGOT, Change from Baseline at Week 24 (n= 4,13,17) -0  (1.5) -0  (8.2) -0  (7.1)
SGOT, Change from Baseline at Week 48 (n= 4,13,17) -1  (7.8) -0  (6.9) -0  (6.8)
ALP, Change from Baseline at Week 24 (n=4, 12, 16) 10  (29.8) 26  (23.2) 22  (24.9)
ALP, Change from Baseline at Week 48 (n=4, 12, 16) 47  (87.6) 36  (26.5) 39  (45.6)
SGPT, Change from Baseline at Week 24 (n=4,13,17) -9  (15.3) -2  (13.6) -4  (13.8)
SGPT, Change from Baseline at Week 48 (n=4,13,17) -2  (13.4) -3  (12.1) -3  (12)
GGT, Change from Baseline at Week 24 (n=4, 13, 17) 5  (4.7) -7  (18.7) -4  (17.1)
GGT, Change from Baseline at Week 48 (n=4, 13, 17) 5  (2.1) -5  (18.5) -2  (16.7)
9.Primary Outcome
Title Change In Total Bilirubin, Creatinine, Uric Acid From Baseline
Hide Description Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline (Day 1), Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Mean (Standard Deviation)
Unit of Measure: umol/L
Total Bilirubin-Change from BL at Wk 24(n=4,12,16) 2  (2.8) 2  (5.5) 2  (4.9)
Total Bilirubin-Change from BL at Wk 48(n=4,12,16) 1  (1.1) 2  (6.9) 1  (5.9)
Cretainine- Change from BL at Wk 24 (n=4, 13,17) -2  (6.7) 3  (10) 2  (9.5)
Cretainine- Change from BL at Wk 48 (n=4, 13,17) 3  (10.7) 5  (9.2) 5  (9.3)
Uric acid- Change from BL at Wk 24 (n=4, 13,17) -27  (54.3) 68  (55.1) 46  (67.6)
Uric acid- Change from BL at Wk 48 (n=3,13,16) -42  (108.4) 61  (63.5) 41  (80.6)
10.Primary Outcome
Title 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
Hide Description Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline (Day 1), Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Mean (Standard Deviation)
Unit of Measure: mmol/L
BUN,Change from Baseline at Week 24 (n= 3, 13, 16) -1.5  (2.78) 1  (2.2) 0.5  (2.43)
BUN,Change from Baseline at Week 48 (n= 3, 13, 16) 0.4  (0.66) 1.1  (2.0) 0.9  (1.82)
LDL,Change from Baseline at Week 24 (n= 3, 13, 16) 0.21  (0.237) 0.21  (1.389) 0.21  (1.245)
LDL,Change from Baseline at Week 48 (n= 3, 13, 16) 0.23  (0.596) -0.11  (1.038) -0.04  (0.963)
HDL,Change from Baseline at Week 24 (n= 3, 13, 16) 0.21  (0.202) 0.13  (0.369) 0.15  (0.34)
HDL,Change from Baseline at Week 48 (n= 3, 13, 16) 0.41  (0.233) 0.17  (0.387) 0.21  (0.37)
Triglyceride,Change from BL at Wk 24 (n=4,13, 17) -0.28  (0.597) -0.19  (1.376) -0.21  (1.22)
Triglyceride,Change from BL at Wk 48 (n=4,13, 17) -0.19  (0.496) -0.15  (1.558) -0.16  (1.366)
Calcium,Change from BL at Wk 24 (n=2, 12, 14) -0.15  (0.04) 0.15  (0.17) 0.11  (0.19)
Calcium,Change from BL at Wk 48 (n=2, 12, 14) -0.16  (0.09) 0.09  (0.17) 0.06  (0.18)
Potassium,Change from BL at Wk 24 (n=4,13, 17) -0.1  (0.16) -0.3  (0.63) -0.2  (0.56)
Potassium,Change from BL at Wk 48 (n=4,13, 17) 0.2  (0.59) -0.2  (0.54) -0.1  (0.57)
Sodium,Change from BL at Wk 24 (n=4,13, 17) 2  (1.3) -1  (2.3) -0  (2.3)
Sodium,Change from BL at Wk 48 (n=4,13, 17) 1  (2.2) -1  (3.8) -0  (3.5)
Chloride,Change from BL at Wk 24 (n=4,13, 17) -1  (2.8) -2  (4.2) -2  (3.9)
Chloride,Change from BL at Wk 48 (n=4,13, 17) 1  (1.3) -2  (3.6) -1  (3.3)
Phosphate,Change from BL at Wk 24 (n=2, 12, 14) -0.02  (0.114) 0.17  (0.188) 0.14  (0.188)
Phosphate,Change from BL at Wk 48 (n=2, 13, 15) -0.26  (0.0) 0.12  (0.212) 0.07  (0.237)
Fasting Glucose,Change from BL at Wk 24(n=4,13,17) -0.26  (0.963) 0.02  (1.253) -0.05  (1.169)
Fasting Glucose,Change from BL at Wk 48(n=4,13,17) -0.07  (0.857) 0.14  (1.537) 0.09  (1.385)
11.Primary Outcome
Title Change In Hematuria, Glycosuria And Proteinuria From Baseline
Hide Description Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline (Day 1), Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Mean (Standard Deviation)
Unit of Measure: [0 to 4+]
Hematuria-Change from BL at Wk 24 (n= 1, 2, 3) 0  (0) 0  (0) 0  (0)
Hematuria-Change from BL at Wk 48 (n= 1, 2, 3) 0  (0) 0  (0) 0  (0)
Glycosuria-Change from BL at Wk 24 (n= 1, 2, 3) 0  (0) 0  (0) 0  (0)
Glycosuria-Change from BL at Wk 48 (n= 1, 2, 3) 0  (0) 0  (0) 0  (0)
Proteinuria-Change from BL at Wk 24 (n= 1, 2, 3) 0  (0) 0  (0) 0  (0)
Proteinuria-Change from BL at Wk 48 (n= 1, 2, 3) 0  (0) 0  (0) 0  (0)
12.Secondary Outcome
Title Plasma Trough Concentrations (Ctrough) for Ritonavir
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 5 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
577  (366) 995  (548)
13.Secondary Outcome
Title Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 5 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
Saquinavir 2910  (3110) 5570  (2780)
Ritonavir 2050  (1270) 3370  (2020)
14.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Ritonavir
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 5 13
Mean (Standard Deviation)
Unit of Measure: h*ug/mL
13.6  (8.18) 21.8  (11.6)
15.Secondary Outcome
Title Change From Baseline in Mean Human Immunodeficiency Virus Viral Load
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
Change from Baseline at Week 24 (n= 3, 13, 16) -0.75  (1.48) -1.81  (1.57) -1.61  (1.57)
Change from Baseline at Week 48 (n= 3, 13, 16) -1.27  (1.01) -1.39  (1.53) -1.36  (1.42)
16.Secondary Outcome
Title Number of Participants With Human Immunodeficiency Virus (HIV) –Ribonucleic Acid (RNA) <400 Copies/mL
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Measure Type: Number
Unit of Measure: participants
Baseline (n= 5, 13, 18) 1 5 6
Week 24 (n= 3, 13, 16) 2 13 15
Week 48 (n= 3, 13, 16) 2 11 13
17.Secondary Outcome
Title Number of Participants With Human Immunodeficiency Virus (HIV) –Ribonucleic Acid (RNA) <50 Copies/mL
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Measure Type: Number
Unit of Measure: participants
Baseline (n= 5, 13, 18) 0 4 4
Week 24 (n= 3, 13, 16) 2 11 13
Week 48 (n= 3, 13, 16) 2 9 11
18.Secondary Outcome
Title Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) –Ribonucleic Acid (RNA )
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Measure Type: Number
Unit of Measure: participants
Week 8 (n= 4, 12, 16) 1 7 8
Week 24 (n= 3, 13, 16) 1 8 9
Week 48 (n= 3, 13, 16) 1 7 8
19.Secondary Outcome
Title Number of Participants With Virological Failure
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Measure Type: Number
Unit of Measure: participants
VF at Week 12 (n= 5, 13, 18) 2 1 3
VF at Week 24 (n= 5, 13, 18) 2 0 2
VF at Week 48 (n= 5, 13, 18) 3 1 4
HIV-RNA <= 10,000 copies/mL at Wk 12 (n= 3, 6, 9) 1 0 1
HIV-RNA <= 10,000 copies/mL at Wk 24 (n= 3, 6, 9) 1 0 1
HIV-RNA <= 10,000 copies/mL at Wk 48 (n= 3, 6, 9) 2 0 2
HIV-RNA >10,000 copies/mL at Week 12 (n= 2, 7, 9) 1 1 2
HIV-RNA >10,000 copies/mL at Week 24 (n= 2, 7, 9) 1 0 1
HIV-RNA >10,000 copies/mL at Week 48 (n= 2, 7, 9) 1 1 2
20.Secondary Outcome
Title Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count
Hide Description 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
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Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Mean (Standard Deviation)
Unit of Measure: count/uL
Change from Baseline at Week 24 (n= 3, 12, 15) 94.90  (643.28) -34.53  (821.31) -8.65  (769.41)
Change from Baseline at Week 48 (n= 3, 12, 15) -50.07  (1013.23) 126.11  (528.49) 90.87  (609.46)
21.Secondary Outcome
Title Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Group A Group B Total
Hide Arm/Group Description:
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.
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.
Participants 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.
Overall Number of Participants Analyzed 5 13 18
Mean (Standard Deviation)
Unit of Measure: count/uL
Change from Baseline at Week 24 (n= 3, 12, 15) -200.49  (161.05) -3.50  (790.86) -42.90  (708.37)
Change from Baseline at Week 48 (n= 3, 12, 15) -92.07  (455.23) 40.52  (641.27) 14.00  (596.43)
Time Frame Up to 56 weeks
Adverse Event Reporting Description Serious adverse events and non-serious adverse events are reported in Safety Population Set.
 
Arm/Group Title Group A Group B Total
Hide Arm/Group Description 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. 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. Participants 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.
All-Cause Mortality
Group A Group B Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group A Group B Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/5 (20.00%)   2/13 (15.38%)   3/18 (16.67%) 
Infections and infestations       
Pneumonia  1  1/5 (20.00%)  1/13 (7.69%)  2/18 (11.11%) 
Respiratory, thoracic and mediastinal disorders       
Bronchitis  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group A Group B Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)   9/13 (69.23%)   14/18 (77.78%) 
Gastrointestinal disorders       
Vomiting  1  1/5 (20.00%)  2/13 (15.38%)  3/18 (16.67%) 
Diarrhoea  1  0/5 (0.00%)  3/13 (23.08%)  3/18 (16.67%) 
Dental Caries  1  1/5 (20.00%)  2/13 (15.38%)  3/18 (16.67%) 
Abdominal Pain  1  1/5 (20.00%)  0/13 (0.00%)  1/18 (5.56%) 
Abdominal Pain Lower  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Gingivitis  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Constipation  1  2/5 (40.00%)  0/13 (0.00%)  2/18 (11.11%) 
General disorders       
Gait Disturbance  1  1/5 (20.00%)  0/13 (0.00%)  1/18 (5.56%) 
Infections and infestations       
Upper Respiratory Tract Infection  1  1/5 (20.00%)  1/13 (7.69%)  2/18 (11.11%) 
Bronchitis  1  0/5 (0.00%)  2/13 (15.38%)  2/18 (11.11%) 
Impetigo  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Otitis Media  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Cellulitis  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Cystitis  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Gastroenteritis  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Giardiasis  1  1/5 (20.00%)  0/13 (0.00%)  1/18 (5.56%) 
Herpangina  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Nasopharyngitis  1  1/5 (20.00%)  0/13 (0.00%)  1/18 (5.56%) 
Otitis Media Acute  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Pharyngitis  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Pneumonia  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Pyoderma  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Rhinitis  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Toxocariasis  1  1/5 (20.00%)  0/13 (0.00%)  1/18 (5.56%) 
Urinary Tract Infection  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Investigations       
Weight Decreased  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders       
Synovitis  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Renal and urinary disorders       
Enuresis  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Epistaxis  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Skin and subcutaneous tissue disorders       
Dermatitis  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Intertrigo  1  0/5 (0.00%)  1/13 (7.69%)  1/18 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 61 6878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00623597     History of Changes
Other Study ID Numbers: NV20911
2007-004617-34
First Submitted: February 18, 2008
First Posted: February 26, 2008
Results First Submitted: December 10, 2015
Results First Posted: January 14, 2016
Last Update Posted: March 7, 2016