Pharmacokinetics and Safety Study of Tipranavir in Combin... | NCT00076999 | Trialant
NCT00076999
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
May 12, 2014Estimated
Enrollment
115Actual
Phase
Phase 1
Conditions
HIV Infections
Interventions
TPV oral solution
TPV oral solution
RTV oral solution
RTV oral solution
Countries
United States
Argentina
Brazil
Canada
France
Germany
Italy
Mexico
Puerto Rico
Spain
Protocol Section
Identification Module
NCT ID
NCT00076999
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1182.14
Secondary IDs
Not provided
Brief Title
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
Official Title
Multiple-dose, Open-label, Randomized, Safety and Pharmacokinetic Study of Tipranavir in Combination With Low-dose Ritonavir in HIV-infected Pediatric Patients
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Apr 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2003
Primary Completion Date
Jun 2010Actual
Completion Date
Not provided
First Submitted Date
Feb 9, 2004
First Submission Date that Met QC Criteria
Feb 9, 2004
First Posted Date
Feb 10, 2004Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 27, 2011
Results First Submitted that Met QC Criteria
Jun 27, 2011
Results First Posted Date
Jul 25, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 25, 2014
Last Update Posted Date
May 12, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir and ritonavir in this age group, and to determine the relative bioavailability of the TPV liquid formulation and TPV capsule formulation in adolescents switching from liquid to capsule.
The secondary objective of this study is the determination of the dose of topranavir and ritonavir (TPV/r) in children and adolescents between 2 and 18 years of age required for an adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.
Detailed Description
Not provided
Conditions Module
Conditions
HIV Infections
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
115Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
TPV/r 290/115 mg/m^2
Experimental
TPV and RTV oral solution low dose
Drug: TPV oral solution
Drug: RTV oral solution
TPV/r 375/150 mg/m^2
Experimental
TPV and RTV oral solution high dose
Drug: TPV oral solution
Drug: RTV oral solution
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TPV oral solution
Drug
Tipranavir oral solution
TPV/r 290/115 mg/m^2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
up to 288 weeks
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
up to 288 weeks
Secondary Outcomes
Measure
Description
Time Frame
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)
baseline, week 24
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Males and females between 2 and 18 years of age.
A confirmed diagnosis of HIV-1 infection as defined by two positive assays from two different samples taken at least two weeks apart. The two results may be any combination of the following:
HIV ribonucleic acid (RNA) detected by reverse transcriptase (RT)-polymerase chain reaction(PCR) or HIV proviral deoxyribonucleic acid (DNA) detected by PCR HIV culture p24 antigen detection Licensed HIV enzyme-linked immunosorbent assay (ELISA) with confirmatory Western blot
Viral load > 1500 RNA copies/mL.
Acceptable screening laboratory values indicative of adequate baseline organ function. Laboratory values are considered acceptable if severity is no higher than Grade 1 for all tests defined by the Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Pediatric Adverse Experiences (> 3 months of age) with the following exceptions:
Signed informed consent prior to study participation from the patient or a legal guardian.
Active assent must be given by the patient if the child and/or adolescent is capable of understanding the provided study information (this applies to children with the intellectual age of 7 years or greater)
In the opinion of the investigator, an ability to take medications and comply with the requirements of the protocol.
Exclusion criteria:
Female patients of childbearing potential who:
have a positive serum pregnancy test at screening are breast feeding are planning on becoming pregnant are not willing to use two methods of contraception to include at least one barrier method (e.g. latex condom plus spermicidal jelly/foam)
Active hepatitis B or C disease defined as hepatitis B surface antigen (HBsAg) positivity or hepatitis C (HCV) antibody or RNA positivity with aspartate aminotransferase(AST)/ alanine aminotransferase(ALT) > Grade 2.
Life expectancy < 12 months.
Patients who are unwilling to abstain from ingesting contraindicated medications and substances which may significantly affect plasma levels of the study medications, notably:
Grapefruit juice or Seville oranges Herbal preparations containing St. John's Wort or milk thistle Garlic supplements
Active substance abuse.
Use of investigational medications or vaccines within 28 days before study entry or during the trial. Some expanded access antiretroviral medications may be acceptable, but must be approved by sponsor.
Requirement for any therapy for malignancy or immunomodulatory drug (e.g. interferon, cyclosporine, hydroxyurea, interleukin-2) within 28 days of study entry. Replacement intravenous gamma globulin treatment is acceptable.
Any active opportunistic infection within 28 days before study entry or other clinically significant findings that may compromise the outcome of the study.
Patients with malabsorption, severe chronic diarrhea or vomiting (more than two episodes of moderate or severe intensity, not attributed to medication therapy and lasting more than four days) within 28 days of the study.
Evidence or symptoms of encephalopathy or developmental delay that would reduce compliance.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
2 Years
Maximum Age
18 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Boehringer Ingelheim
Boehringer Ingelheim
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
1182.14.00001 Boehringer Ingelheim Investigational Site
Los Angeles
California
United States
1182.14.00006 Boehringer Ingelheim Investigational Site
Salazar JC, Cahn P, Della Negra M, De Aquino MZ, Robinson PA, Jelaska A, Mikl J. Efficacy and safety of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents: 5 years of experience. Pediatr Infect Dis J. 2014 Apr;33(4):396-400. doi: 10.1097/INF.0000000000000038.
1182.14.00005 Boehringer Ingelheim Investigational Site
San Juan
Puerto Rico
1182.14.34002 Boehringer Ingelheim Investigational Site
Barcelona
Spain
1182.14.34001 Boehringer Ingelheim Investigational Site
Madrid
Spain
Salazar JC, Cahn P, Yogev R, Negra MD, Castelli-Gattinara G, Fortuny C, Flynn PM, Giaquinto C, Ruan PK, Smith ME, Mikl J, Jelaska A; PACTG 1051/BI Study Team. Efficacy, safety and tolerability of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents. AIDS. 2008 Sep 12;22(14):1789-98. doi: 10.1097/QAD.0b013e32830c481b.
FG002
TPV OS 12-18 Yrs
Tipranavir Oral Solution (TPV OS), ages 12-18
FG003
TPV SEDDS 6-<12 Yrs
TPV self-emulsifying drug delivery system (SEDDS), ages 6-11
FG004
TPV SEDDS 12-18 Yrs
TPV self-emulsifying drug delivery system (SEDDS), ages 12-18
FG00025 subjects
FG00131 subjects
FG00219 subjects
FG0036 subjects
FG00434 subjects
COMPLETED
FG00013 subjects
FG0017 subjects
FG0022 subjects
FG0035 subjects
FG0049 subjects
NOT COMPLETED
FG00012 subjects
FG00124 subjects
FG00217 subjects
FG0031 subjects
FG00425 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0018 subjects
FG0026 subjects
FG0030 subjects
FG0042 subjects
Protocol Violation
FG0000 subjects
FG0013 subjects
FG0024 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0014 subjects
FG0023 subjects
FG0030 subjects
FG004
Other reason (not specified)
FG0008 subjects
FG0018 subjects
FG0024 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
BG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
BG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
BG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00025
BG00137
BG00224
BG00329
BG004115
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0004.1± 1.1
BG0019.5± 1.4
BG00214.4± 1.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG00115
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Hispanic / Latino
Title
Measurements
BG00022
BG00120
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG00018
BG00126
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
North America
Title
Measurements
BG0003
BG00114
BG002
Antiretroviral Experienced
Number
participants
Title
Denominators
Categories
Yes
Title
Measurements
BG00024
BG00136
BG002
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
Secondary
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Number
participants
baseline, week 24
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
OG00025
OG00137
OG00224
OG003
Title
Denominators
Categories
Viral load reduction
Title
Measurements
OG00020
OG00118
OG0029
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
Fisher Exact
0.02
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
Fisher Exact
Secondary
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Number
participants
baseline, week 48
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Secondary
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Number
participants
baseline, week 100
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Secondary
Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Number
participants
baseline, week 24
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Secondary
Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Number
participants
baseline, week 48
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Secondary
Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Number
participants
baseline, week 100
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Secondary
Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Number
participants
baseline, week 24
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Secondary
Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Number
participants
baseline, week 48
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Secondary
Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Number
participants
baseline, week 100
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Secondary
Baseline Median Viral Load log10 Copies/mL
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Median
Inter-Quartile Range
log10 copies/mL
baseline
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Secondary
Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Median
Inter-Quartile Range
log10 copies/mL
baseline, week 24
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Secondary
Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Median
Inter-Quartile Range
log10 copies/mL
baseline, week 48
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Secondary
Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Median
Inter-Quartile Range
log10 copies/mL
baseline, week 100
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Secondary
Baseline Median CD4+ Cell Count (Cells/mm3)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Median
Inter-Quartile Range
cells/mm3
baseline
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Secondary
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Median
Inter-Quartile Range
cells/mm3
baseline, week 24
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Secondary
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Median
Inter-Quartile Range
cells/mm3
baseline, week 48
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Secondary
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward)
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Median
Inter-Quartile Range
cells/mm3
baseline, week 100
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Secondary
Median Baseline CD4 Percent
Percentage of lymphocytes that are CD4 cells
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Median
Inter-Quartile Range
percentage of cells
baseline
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Secondary
Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward)
Percentage of lymphocytes that are CD4 cells
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Median
Inter-Quartile Range
percentage of cells
baseline, week 24
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Secondary
Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward)
Percentage of lymphocytes that are CD4 cells
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Median
Inter-Quartile Range
percentage of cells
baseline, week 48
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Secondary
Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward)
Percentage of lymphocytes that are CD4 cells
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Median
Inter-Quartile Range
percentage of cells
baseline, week 100
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Secondary
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Number
participants
week 8
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Secondary
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Number
participants
week 16
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Secondary
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Number
participants
week 24
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Secondary
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Posted
Number
participants
week 48
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
Primary
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment.
Posted
Number
participants
up to 288 weeks
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 6-<12 Yrs
Patients treated with Tipranavir SEDDS, ages 6-11
Primary
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment.
Posted
Number
participants
up to 288 weeks
ID
Title
Description
OG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
OG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
OG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
OG003
TPV SEDDS 6-<12 Yrs
Patients treated with Tipranavir SEDDS, ages 6-11
Time Frame
Entire study (18Feb2004 to 30Jun2010)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
TPV OS 2-<6 Yrs
Patients treated with Tipranavir Oral Solution, ages 2-5
10
25
14
25
EG001
TPV OS 6-<12 Yrs
Patients treated with Tipranavir Oral Solution, ages 6-11
13
31
18
31
EG002
TPV OS 12-18 Yrs
Patients treated with Tipranavir Oral Solution, ages 12-18
8
19
10
19
EG003
TPV SEDDS 6-<12 Yrs
Patients treated with Tipranavir SEDDS, ages 6-11
1
6
5
6
EG004
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
7
34
27
34
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG0030 affected6 at risk
EG0040 affected34 at risk
Aplasia pure red cell
Blood and lymphatic system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Thrombotic thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Acute abdomen
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0012 affected31 at risk
EG0020 affected19 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Pyrexia
General disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0012 affected31 at risk
EG0020 affected19 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Appendicitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Epstein-Barr virus infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Erythema infectiosum
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0021 affected19 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Groin abscess
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Mastoiditis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0012 affected31 at risk
EG0020 affected19 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0003 affected25 at risk
EG0011 affected31 at risk
EG0022 affected19 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Varicella
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Blood potassium decreased
Investigations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Coagulation time prolonged
Investigations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Hepatic enzyme abnormal
Investigations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Investigation
Investigations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Liver function test abnormal
Investigations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Psychiatric investigation
Investigations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Cholesteatoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Lymphoproliferative disorder
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Convulsion
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Syncope
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Hallucinations, mixed
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Adenoidal hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Visual impairment
Eye disorders
MedDRA (13.0)
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Oesophageal disorder
Gastrointestinal disorders
MedDRA (13.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Oesophageal infection
Infections and infestations
MedDRA (13.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA (13.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Psychosomatic disease
Psychiatric disorders
MedDRA (13.0)
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0012 affected31 at risk
EG0021 affected19 at risk
EG0031 affected6 at risk
EG0043 affected34 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0012 affected31 at risk
EG0020 affected19 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0021 affected19 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0013 affected31 at risk
EG0020 affected19 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0005 affected25 at risk
EG0013 affected31 at risk
EG0023 affected19 at risk
EG003
Eye pruritus
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0012 affected31 at risk
EG0020 affected19 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0012 affected31 at risk
EG0020 affected19 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0021 affected19 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0012 affected31 at risk
EG0023 affected19 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0015 affected31 at risk
EG0020 affected19 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0013 affected31 at risk
EG0021 affected19 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0021 affected19 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG00012 affected25 at risk
EG00111 affected31 at risk
EG0022 affected19 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0012 affected31 at risk
EG0020 affected19 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0012 affected31 at risk
EG0020 affected19 at risk
EG003
Gingivitis
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0011 affected31 at risk
EG0022 affected19 at risk
EG003
Malocclusion
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0013 affected31 at risk
EG0020 affected19 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0003 affected25 at risk
EG0014 affected31 at risk
EG0024 affected19 at risk
EG003
Parotid gland enlargement
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0003 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0022 affected19 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0012 affected31 at risk
EG0020 affected19 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG00014 affected25 at risk
EG00111 affected31 at risk
EG0025 affected19 at risk
EG003
Asthenia
General disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Fatigue
General disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0022 affected19 at risk
EG003
Gait disturbance
General disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0021 affected19 at risk
EG003
Influenza like illness
General disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Injection site reaction
General disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Pyrexia
General disorders
MedDRA version 13.0
Systematic Assessment
EG0009 affected25 at risk
EG0018 affected31 at risk
EG0026 affected19 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0011 affected31 at risk
EG0021 affected19 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0022 affected19 at risk
EG003
Adenovirus infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Body tinea
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0012 affected31 at risk
EG0020 affected19 at risk
EG003
Bronchitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0022 affected19 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Cryptosporidiosis infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Ear infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0016 affected31 at risk
EG0020 affected19 at risk
EG003
Folliculitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0005 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
HIV infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0012 affected31 at risk
EG0020 affected19 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0021 affected19 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0012 affected31 at risk
EG0021 affected19 at risk
EG003
Impetigo
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0012 affected31 at risk
EG0021 affected19 at risk
EG003
Influenza
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0003 affected25 at risk
EG0013 affected31 at risk
EG0020 affected19 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0006 affected25 at risk
EG0015 affected31 at risk
EG0021 affected19 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0013 affected31 at risk
EG0023 affected19 at risk
EG003
Oral herpes
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0014 affected31 at risk
EG0020 affected19 at risk
EG003
Otitis externa
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0013 affected31 at risk
EG0022 affected19 at risk
EG003
Otitis media
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0006 affected25 at risk
EG0014 affected31 at risk
EG0021 affected19 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0004 affected25 at risk
EG0013 affected31 at risk
EG0021 affected19 at risk
EG003
Parotitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0005 affected25 at risk
EG0015 affected31 at risk
EG0022 affected19 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0005 affected25 at risk
EG0011 affected31 at risk
EG0021 affected19 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Rhinitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0013 affected31 at risk
EG0021 affected19 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0009 affected25 at risk
EG0012 affected31 at risk
EG0020 affected19 at risk
EG003
Skin candida
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0005 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0009 affected25 at risk
EG0017 affected31 at risk
EG0022 affected19 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Varicella
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0003 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0012 affected31 at risk
EG0020 affected19 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0015 affected31 at risk
EG0020 affected19 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0012 affected31 at risk
EG0023 affected19 at risk
EG003
Weight decreased
Investigations
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0021 affected19 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0012 affected31 at risk
EG0021 affected19 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Epiphyses delayed fusion
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0021 affected19 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0022 affected19 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0021 affected19 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0014 affected31 at risk
EG0020 affected19 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Convulsion
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0022 affected19 at risk
EG003
Headache
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0017 affected31 at risk
EG0024 affected19 at risk
EG003
Mental impairment
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Syncope
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Mental disorder
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Enuresis
Renal and urinary disorders
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0022 affected19 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG00010 affected25 at risk
EG00113 affected31 at risk
EG0023 affected19 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0013 affected31 at risk
EG0021 affected19 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0015 affected31 at risk
EG0024 affected19 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0014 affected31 at risk
EG0021 affected19 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0014 affected31 at risk
EG0020 affected19 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected31 at risk
EG0021 affected19 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0011 affected31 at risk
EG0021 affected19 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected31 at risk
EG0020 affected19 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0002 affected25 at risk
EG0012 affected31 at risk
EG0021 affected19 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0012 affected31 at risk
EG0020 affected19 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0012 affected31 at risk
EG0020 affected19 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0011 affected31 at risk
EG0022 affected19 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Haematoma
Vascular disorders
MedDRA version 13.0
Systematic Assessment
EG0001 affected25 at risk
EG0011 affected31 at risk
EG0020 affected19 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Point of Contact
Title
Organization
Phone
Extension
Email
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
ID
Term
D015658
HIV Infections
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D015229
Sexually Transmitted Diseases, Viral
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
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D019438
Ritonavir
Ancestor Terms
ID
Term
D013844
Thiazoles
D013457
Sulfur Compounds
D009930
Organic Chemicals
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
9 subjects
0 subjects
1 subjects
13 subjects
15.1
± 1.7
BG00410.8± 4.5
10
BG00315
BG00450
Male
BG00015
BG00122
BG00214
BG00314
BG00465
11
BG0038
BG00461
Mixed Race
Title
Measurements
BG0001
BG0010
BG0022
BG0032
BG0045
Unknown
Title
Measurements
BG0002
BG00117
BG00211
BG00319
BG00449
16
BG00320
BG00480
Black
Title
Measurements
BG0006
BG00110
BG0028
BG0039
BG00433
Asian
Title
Measurements
BG0001
BG0011
BG0020
BG0030
BG0042
13
BG00311
BG00441
South America and Mexico
Title
Measurements
BG00022
BG00114
BG0024
BG0035
BG00445
Europe
Title
Measurements
BG0000
BG0019
BG0027
BG00313
BG00429
24
BG00328
BG004112
No
Title
Measurements
BG0001
BG0011
BG0020
BG0031
BG0043
29
13
No viral load reduction
Title
Measurements
OG0005
OG00119
OG00215
OG00316
0.78
95
No
Superiority or Other
OG00025
OG00137
OG00224
OG00329
Title
Denominators
Categories
Viral load reduction
Title
Measurements
OG00019
OG00114
OG0028
OG0039
No viral load reduction
Title
Measurements
OG0006
OG00123
OG00216
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
Fisher Exact
0.00
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
Fisher Exact
1.00
95
No
Superiority or Other
OG00025
OG00137
OG00224
OG00329
Title
Denominators
Categories
Viral load reduction
Title
Measurements
OG00014
OG00113
OG0026
OG0037
No viral load reduction
Title
Measurements
OG00011
OG00124
OG00218
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
Fisher Exact
0.12
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
Fisher Exact
1.00
95
No
Superiority or Other
OG00025
OG00137
OG00224
OG00329
Title
Denominators
Categories
Viral load reduction
Title
Measurements
OG00016
OG00115
OG0028
OG00310
No viral load reduction
Title
Measurements
OG0009
OG00122
OG00216
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
Fisher Exact
0.12
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
Fisher Exact
1.00
95
No
Superiority or Other
OG00025
OG00137
OG00224
OG00329
Title
Denominators
Categories
Viral load reduction
Title
Measurements
OG00018
OG00113
OG0028
OG0039
No viral load reduction
Title
Measurements
OG0007
OG00124
OG00216
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
Fisher Exact
0.01
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
Fisher Exact
1.00
95
No
Superiority or Other
OG00025
OG00137
OG00224
OG00329
Title
Denominators
Categories
Viral load reduction
Title
Measurements
OG00014
OG00111
OG0026
OG0037
No viral load reduction
Title
Measurements
OG00011
OG00126
OG00218
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
Fisher Exact
0.06
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
Fisher Exact
1.00
95
No
Superiority or Other
OG00025
OG00137
OG00224
OG00329
Title
Denominators
Categories
Viral load reduction
Title
Measurements
OG00010
OG00112
OG0026
OG0038
No viral load reduction
Title
Measurements
OG00015
OG00125
OG00218
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
Fisher Exact
0.60
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
Fisher Exact
1.00
95
No
Superiority or Other
OG00025
OG00137
OG00224
OG00329
Title
Denominators
Categories
Viral load reduction
Title
Measurements
OG00013
OG00113
OG0026
OG0038
No viral load reduction
Title
Measurements
OG00012
OG00124
OG00218
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
Fisher Exact
0.20
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
Fisher Exact
1.00
95
No
Superiority or Other
OG00025
OG00137
OG00224
OG00329
Title
Denominators
Categories
Viral load reduction
Title
Measurements
OG00012
OG00111
OG0025
OG0036
No viral load reduction
Title
Measurements
OG00013
OG00126
OG00219
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
Fisher Exact
0.18
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
Fisher Exact
1.00
95
No
Superiority or Other
OG00025
OG00137
OG00224
OG00329
Title
Denominators
Categories
Title
Measurements
OG0005.0± 4.5, 5.3(4.5 to 5.3)
OG0014.6± 4.4, 5.1(4.4 to 5.1)
OG0025.1± 4.0, 5.5(4.0 to 5.5)
OG0034.6(4.1 to 5.0)
Participants
OG00025
OG00137
OG00224
OG00329
Title
Denominators
Categories
Title
Measurements
OG000-2.5± -3.0, -1.8(-3.0 to -1.8)
OG001-1.7± -2.7. -0.4(-2.7 to -0.4)
OG002-0.4± -1.7, 0.0(-1.7 to 0.0)
OG003-1.1(-2.3 to 0.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
ANOVA
0.02
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
ANOVA
0.47
95
No
Superiority or Other
Participants
OG00025
OG00137
OG00224
OG00329
Title
Denominators
Categories
Title
Measurements
OG000-2.7± -3.3, -1.5(-3.3 to -1.5)
OG001-1.0± -2.4, -0.1(-2.4 to -0.1)
OG002-0.4± -1.6, 0.0(-1.6 to 0.0)
OG003-0.8(-2.2 to 0.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
ANOVA
0.00
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
ANOVA
0.81
95
No
Superiority or Other
Participants
OG00025
OG00137
OG00224
OG00329
Title
Denominators
Categories
Title
Measurements
OG000-2.7± -3.3, -1.0(-3.3 to -1.0)
OG001-1.2± -2.4, -0.1(-2.4 to -0.1)
OG002-0.2± -1.5, 0.0(-1.5 to 0.0)
OG003-0.4(-1.9 to 0.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
ANOVA
0.00
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
ANOVA
0.69
95
No
Superiority or Other
OG00023
OG00135
OG00223
OG00329
Title
Denominators
Categories
Title
Measurements
OG000795± 536,1229(536 to 1229)
OG001398± 232,734(232 to 734)
OG002208± 100,475(100 to 475)
OG003330(180 to 389)
OG00023
OG00135
OG00223
OG00329
Title
Denominators
Categories
Title
Measurements
OG000293± 27,396(27 to 396)
OG001133± 5,217(5 to 215)
OG00224± 0, 56(0 to 56)
OG00356(0 to 168)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
ANOVA
0.64
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
ANOVA
0.26
95
No
Superiority or Other
OG00023
OG00135
OG00223
OG00329
Title
Denominators
Categories
Title
Measurements
OG000323± -110,529(-110 to 529)
OG001143± -6,249(-6 to 249)
OG00221± 0, 95(0 to 95)
OG00339(-61 to 153)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
ANOVA
0.25
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
ANOVA
0.70
95
No
Superiority or Other
Participants
OG00023
OG00135
OG00223
OG00329
Title
Denominators
Categories
Title
Measurements
OG000294± -125,416(-125 to 416)
OG001121± -9,319(-8 to 319)
OG00212± -1,100(-1 to 100)
OG00345(0 to 124)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
ANOVA
0.73
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
ANOVA
0.79
95
No
Superiority or Other
Participants
OG00023
OG00135
OG00223
OG00329
Title
Denominators
Categories
Title
Measurements
OG00026± 19, 35(19 to 35)
OG00119± 10, 29(10 to 29)
OG00212± 8, 21(8 to 21)
OG00319(14 to 25)
Counts
Participants
OG00023
OG00135
OG00223
OG00329
Title
Denominators
Categories
Title
Measurements
OG0007± 2, 10(2 to 10)
OG0014± 0.8(0 to 8)
OG0021± 0.4(0 to 4)
OG0032(0 to 6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
ANOVA
0.38
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
ANOVA
0.20
95
No
Superiority or Other
Counts
Participants
OG00023
OG00135
OG00223
OG00329
Title
Denominators
Categories
Title
Measurements
OG0007± 2, 13(2 to 13)
OG0015± 0.8(0 to 8)
OG0021± 0.5(0 to 5)
OG0033(-1 to 6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
ANOVA
0.08
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
ANOVA
0.36
95
No
Superiority or Other
Units
Counts
Participants
OG00023
OG00135
OG00223
OG00329
Title
Denominators
Categories
Title
Measurements
OG0006± 3, 10(3 to 10)
OG0014± 0.9(0 to 9)
OG0021± 0.7(0 to 7)
OG0030(-2 to 7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs
ANOVA
0.23
95
No
Superiority or Other
OG002
OG003
Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs
ANOVA
0.23
95
No
Superiority or Other
OG00024
OG00134
OG00221
OG00328
Title
Denominators
Categories
Compliance
Title
Measurements
OG00016
OG00121
OG00213
OG00310
Non-compliance
Title
Measurements
OG0008
OG00113
OG0028
OG003
OG00025
OG00134
OG00219
OG00326
Title
Denominators
Categories
Compliance
Title
Measurements
OG00016
OG00120
OG00210
OG00313
Non-compliance
Title
Measurements
OG0009
OG00114
OG0029
OG003
OG00025
OG00134
OG00216
OG00325
Title
Denominators
Categories
Compliance
Title
Measurements
OG00017
OG00117
OG0026
OG00314
Non-compliance
Title
Measurements
OG0008
OG00117
OG00210
OG003
OG00024
OG00129
OG00213
OG00322
Title
Denominators
Categories
Compliance
Title
Measurements
OG00019
OG00111
OG0025
OG00311
Non-compliance
Title
Measurements
OG0005
OG00118
OG0028
OG003
OG004
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
Units
Counts
Participants
OG00025
OG00131
OG00219
OG0036
OG00434
Title
Denominators
Categories
Total with any severe drug-related adverse events
Title
Measurements
OG0002
OG0016
OG0023
OG0032
OG0045
Gamma-glutamyl transferase increased
Title
Measurements
OG0001
OG0012
OG0022
OG003
Alanine aminotransferase increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Liver function test abnormal
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hepatic enzyme abnormal
Title
Measurements
OG0000
OG0011
OG0020
OG003
Anemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Nausea
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hyperamylasemia
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG004
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18