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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004617-34 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ritonavir | Drug | 2.5-3.0mg/kg po bid (starting dose) for 48 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-dose at Weeks 8, 12, 24. |
| 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. | 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). |
| 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 | From Baseline (Day 1) till Week 48 and Follow-up (Week 52) |
| Change In Hematocrit From Baseline | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline (Day 1), Week 24 and Week 48 |
| Change In Hemoglobin, Total Protein And Total Albumin From Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-dose at Weeks 8, 12, 24 |
| Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | 1202 | Argentina | ||||
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose at Weeks 8, 12, 24. |
|
Up to 56 weeks
Serious adverse events and non-serious adverse events are reported in Safety Population Set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 61 6878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
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| ID | Term |
|---|---|
| D019438 | Ritonavir |
| D019258 | Saquinavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| saquinavir [Invirase] |
| Drug |
50mg/kg po bid (starting dose) for 48 weeks |
|
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Baseline (Day 1), Week 24 and Week 48 |
| 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. | Baseline (Day 1), Week 24 and Week 48 |
| Change In Red Blood Cell (RBC) Counts From Baseline | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline (Day 1), Week 24 and Week 48 |
| 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. | Baseline (Day 1), Week 24 and Week 48 |
| Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline (Day 1), Week 24 and Week 48 |
| 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. | Baseline (Day 1), Week 24 and Week 48 |
| Change In Hematuria, Glycosuria And Proteinuria From Baseline | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline (Day 1), Week 24 and Week 48 |
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. |
| 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 |
| 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. | 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). |
| 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) | 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. |
| 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 | 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. |
| 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. | 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. |
| 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 | From Week 8 till Week 48 |
| 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. | From Week 12 till Week 48 |
| 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. | Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation |
| 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. | Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation |
| Buenos Aires |
| 1425 |
| Argentina |
| Santa Fe | 3000 | Argentina |
| Madrid | Madrid | 28046 | Spain |
| Madrid | Madrid | 28905 | Spain |
| Valencia | Valencia | 46009 | Spain |
| Bangkok | 10400 | Thailand |
| Khon Kaen | 40002 | Thailand |
| Pathumwan | 10330 | Thailand |
| Payathai | 10400 | Thailand |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | h*ug/mL | 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). |
|
|
|
| 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 | 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. | Posted | Number | participants | From Baseline (Day 1) till Week 48 and Follow-up (Week 52) |
|
|
|
| Primary | Change In Hematocrit From Baseline | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | 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. | Posted | Mean | Standard Deviation | fraction | Baseline (Day 1), Week 24 and Week 48 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose at Weeks 8, 12, 24 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | h*ug/mL | 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). |
|
|
|
| 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) | 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. | Posted | Mean | Standard Deviation | log10 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. |
|
|
|
| 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 | 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. | Posted | Number | participants | 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. |
|
|
|
| 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. | 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. | Posted | Number | participants | 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. |
|
|
|
| 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 | 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. | Posted | Number | participants | From Week 8 till Week 48 |
|
|
|
| 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. | 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. | Posted | Number | participants | From Week 12 till Week 48 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | count/uL | Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | count/uL | Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | g/L | Baseline (Day 1), Week 24 and Week 48 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | 10*9/L | Baseline (Day 1), Week 24 and Week 48 |
|
|
|
| Primary | Change In Red Blood Cell (RBC) Counts From Baseline | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | 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. | Posted | Mean | Standard Deviation | 10*12/L | Baseline (Day 1), Week 24 and Week 48 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | U/L | Baseline (Day 1), Week 24 and Week 48 |
|
|
|
| Primary | Change In Total Bilirubin, Creatinine, Uric Acid From Baseline | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | 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. | Posted | Mean | Standard Deviation | umol/L | Baseline (Day 1), Week 24 and Week 48 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mmol/L | Baseline (Day 1), Week 24 and Week 48 |
|
|
|
| Primary | Change In Hematuria, Glycosuria And Proteinuria From Baseline | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | 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. | Posted | Mean | Standard Deviation | [0 to 4+] | Baseline (Day 1), Week 24 and Week 48 |
|
|
|
| 1 |
| 5 |
| 5 |
| 5 |
| EG001 | 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. | 2 | 13 | 9 | 13 |
| EG002 | Total | 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. | 3 | 18 | 14 | 18 |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Otitis Media | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Giardiasis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Herpangina | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Otitis Media Acute | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Pyoderma | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Toxocariasis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Dental Caries | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Gingivitis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
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| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
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| Gait Disturbance | General disorders | MedDRA (12.1) | Systematic Assessment |
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| Weight Decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
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| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
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| Enuresis | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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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.
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011804 | Quinolines |
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| Week 48 (n= 3, 13, 16) |
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| Week 48 (n= 3, 13, 16) |
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| Week 48 (n= 3, 13, 16) |
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| VF at Week 48 (n= 5, 13, 18) |
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| HIV-RNA <= 10,000 copies/mL at Wk 12 (n= 3, 6, 9) |
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| HIV-RNA <= 10,000 copies/mL at Wk 24 (n= 3, 6, 9) |
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| HIV-RNA <= 10,000 copies/mL at Wk 48 (n= 3, 6, 9) |
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| HIV-RNA >10,000 copies/mL at Week 12 (n= 2, 7, 9) |
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| HIV-RNA >10,000 copies/mL at Week 24 (n= 2, 7, 9) |
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| HIV-RNA >10,000 copies/mL at Week 48 (n= 2, 7, 9) |
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| Total Protein, Change from BL at Wk 24 (n=4,13,17) |
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| Total Protein, Change from BL at Wk 48 (n=4,13,17) |
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| Total Albumin, Change from BL at Wk 24 (n=4,13,17) |
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| Total Albumin, Change from BL at Wk 48 (n=4,13,17) |
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| Platelet, Change from BL at Wk 24 (n= 4,13,17) |
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| Platelet, Change from BL at Wk 48 (n= 4,13,17) |
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| Basophil, Change from BL at Wk 24 (n=4 ,13,17) |
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| Basophil, Change from BL at Wk 48 (n=4 ,13,17) |
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| Lymphocyte, Change from BL at Wk 24 (n=2, 2, 4) |
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| Lymphocyte, Change from BL at Wk 48 (n= 2, 2, 4) |
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| Monocyte, Change from BL at Wk 24 (n= ,13,17) |
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| Monocyte, Change from BL at Wk 48 (n= ,13,17) |
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| Neutrophil, Change from BL at Wk 24 (n=2, 2, 4) |
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| Neutrophil, Change from BL at Wk 48 (n= 2, 2, 4) |
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| Eosinophil, Change from BL at Wk 24 (n=2, 2, 4) |
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| Eosinophil, Change from BL at Wk 48 (n= 2, 2, 4) |
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| SGOT, Change from Baseline at Week 24 (n= 4,13,17) |
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| SGOT, Change from Baseline at Week 48 (n= 4,13,17) |
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| ALP, Change from Baseline at Week 24 (n=4, 12, 16) |
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| ALP, Change from Baseline at Week 48 (n=4, 12, 16) |
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| SGPT, Change from Baseline at Week 24 (n=4,13,17) |
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| SGPT, Change from Baseline at Week 48 (n=4,13,17) |
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| GGT, Change from Baseline at Week 24 (n=4, 13, 17) |
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| GGT, Change from Baseline at Week 48 (n=4, 13, 17) |
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| Cretainine- Change from BL at Wk 24 (n=4, 13,17) |
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| Cretainine- Change from BL at Wk 48 (n=4, 13,17) |
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| Uric acid- Change from BL at Wk 24 (n=4, 13,17) |
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| Uric acid- Change from BL at Wk 48 (n=3,13,16) |
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| LDL,Change from Baseline at Week 24 (n= 3, 13, 16) |
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| LDL,Change from Baseline at Week 48 (n= 3, 13, 16) |
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| HDL,Change from Baseline at Week 24 (n= 3, 13, 16) |
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| HDL,Change from Baseline at Week 48 (n= 3, 13, 16) |
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| Triglyceride,Change from BL at Wk 24 (n=4,13, 17) |
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| Triglyceride,Change from BL at Wk 48 (n=4,13, 17) |
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| Calcium,Change from BL at Wk 24 (n=2, 12, 14) |
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| Calcium,Change from BL at Wk 48 (n=2, 12, 14) |
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| Potassium,Change from BL at Wk 24 (n=4,13, 17) |
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| Potassium,Change from BL at Wk 48 (n=4,13, 17) |
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| Sodium,Change from BL at Wk 24 (n=4,13, 17) |
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| Sodium,Change from BL at Wk 48 (n=4,13, 17) |
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| Chloride,Change from BL at Wk 24 (n=4,13, 17) |
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| Chloride,Change from BL at Wk 48 (n=4,13, 17) |
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| Phosphate,Change from BL at Wk 24 (n=2, 12, 14) |
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| Phosphate,Change from BL at Wk 48 (n=2, 13, 15) |
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| Fasting Glucose,Change from BL at Wk 24(n=4,13,17) |
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| Fasting Glucose,Change from BL at Wk 48(n=4,13,17) |
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| Glycosuria-Change from BL at Wk 24 (n= 1, 2, 3) |
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| Glycosuria-Change from BL at Wk 48 (n= 1, 2, 3) |
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| Proteinuria-Change from BL at Wk 24 (n= 1, 2, 3) |
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| Proteinuria-Change from BL at Wk 48 (n= 1, 2, 3) |
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