HIV Infections
Conditions
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.
Interventions
DRUGTPV oral solution
Tipranavir oral solution
DRUGRTV oral solution
Ritonavir oral solution
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females between 2 and 18 years of age. 2. 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 3. Viral load \> 1500 RNA copies/mL. 4. 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: Grade 2 gamma-glutamyl transferase Grade 2 cholesterol Grade 2 triglycerides 5. 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) 6. In the opinion of the investigator, an ability to take medications and comply with the requirements of the protocol.
Exclusion criteria
1. 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) 2. 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. 3. Life expectancy \< 12 months. 4. 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 5. Active substance abuse. 6. 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. 7. 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. 8. Any active opportunistic infection within 28 days before study entry or other clinically significant findings that may compromise the outcome of the study. 9. 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. 10. Evidence or symptoms of encephalopathy or developmental delay that would reduce compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | up to 288 weeks | 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. |
| Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | up to 288 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures) | baseline, week 100 | — |
| Baseline Median Viral Load log10 Copies/mL | baseline | — |
| 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) | baseline, week 48 | — |
| Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures) | baseline, week 100 | — |
| Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures) | baseline, week 24 | — |
| Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures) | baseline, week 48 | — |
| Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures) | baseline, week 100 | — |
| Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures) | baseline, week 24 | — |
| Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures) | baseline, week 48 | — |
| Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward) | baseline, week 24 | — |
| Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward) | baseline, week 48 | — |
| Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward) | baseline, week 100 | — |
| Baseline Median CD4+ Cell Count (Cells/mm3) | baseline | — |
| Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward) | baseline, week 24 | — |
| Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward) | baseline, week 48 | — |
| Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward) | baseline, week 100 | — |
| Median Baseline CD4 Percent | baseline | Percentage of lymphocytes that are CD4 cells |
| Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward) | baseline, week 24 | Percentage of lymphocytes that are CD4 cells |
| Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward) | baseline, week 48 | Percentage of lymphocytes that are CD4 cells |
| Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward) | baseline, week 100 | Percentage of lymphocytes that are CD4 cells |
| Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8 | week 8 | — |
| Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16 | week 16 | — |
| Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24 | week 24 | — |
| Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48 | week 48 | — |
Countries
Argentina, Brazil, Canada, France, Germany, Italy, Mexico, Puerto Rico, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TPV OS 2-<6 Yrs Patients treated with Tipranavir Oral Solution, ages 2-5 | 25 |
| TPV OS 6-<12 Yrs Patients treated with Tipranavir Oral Solution, ages 6-11 | 37 |
| TPV OS 12-18 Yrs Patients treated with Tipranavir Oral Solution, ages 12-18 | 24 |
| TPV SEDDS 12-18 Yrs Patients treated with Tipranavir SEDDS, ages 12-18 | 29 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 8 | 6 | 0 | 2 |
| Overall Study | Lost to Follow-up | 2 | 1 | 0 | 0 | 0 |
| Overall Study | Other reason (not specified) | 8 | 8 | 4 | 1 | 13 |
| Overall Study | Protocol Violation | 0 | 3 | 4 | 0 | 9 |
| Overall Study | Withdrawal by Subject | 0 | 4 | 3 | 0 | 1 |
Baseline characteristics
| Characteristic | TPV OS 2-<6 Yrs | TPV OS 6-<12 Yrs | TPV OS 12-18 Yrs | TPV SEDDS 12-18 Yrs | Total |
|---|---|---|---|---|---|
| Age, Continuous | 4.1 years STANDARD_DEVIATION 1.1 | 9.5 years STANDARD_DEVIATION 1.4 | 14.4 years STANDARD_DEVIATION 1.7 | 15.1 years STANDARD_DEVIATION 1.7 | 10.8 years STANDARD_DEVIATION 4.5 |
| Antiretroviral Experienced No | 1 participants | 1 participants | 0 participants | 1 participants | 3 participants |
| Antiretroviral Experienced Yes | 24 participants | 36 participants | 24 participants | 28 participants | 112 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 1 participants | 0 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Black | 6 participants | 10 participants | 8 participants | 9 participants | 33 participants |
| Race/Ethnicity, Customized Hispanic / Latino | 22 participants | 20 participants | 11 participants | 8 participants | 61 participants |
| Race/Ethnicity, Customized Mixed Race | 1 participants | 0 participants | 2 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized Unknown | 2 participants | 17 participants | 11 participants | 19 participants | 49 participants |
| Race/Ethnicity, Customized White | 18 participants | 26 participants | 16 participants | 20 participants | 80 participants |
| Region of Enrollment Europe | 0 participants | 9 participants | 7 participants | 13 participants | 29 participants |
| Region of Enrollment North America | 3 participants | 14 participants | 13 participants | 11 participants | 41 participants |
| Region of Enrollment South America and Mexico | 22 participants | 14 participants | 4 participants | 5 participants | 45 participants |
| Sex: Female, Male Female | 10 Participants | 15 Participants | 10 Participants | 15 Participants | 50 Participants |
| Sex: Female, Male Male | 15 Participants | 22 Participants | 14 Participants | 14 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 25 | 18 / 31 | 10 / 19 | 5 / 6 | 27 / 34 |
| serious Total, serious adverse events | 10 / 25 | 13 / 31 | 8 / 19 | 1 / 6 | 7 / 34 |
Outcome results
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.
Time frame: up to 288 weeks
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Prothombin time prolonged | 1 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Neutrophil count decreased | 0 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Triglyceride increased | 0 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Creatinine phosphokinase increased | 4 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Calcium decreased | 0 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Aspartate aminotransferase increased | 0 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Sodium increased | 2 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Calcium increased | 1 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Alanine aminotransferase increased | 0 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Platelets | 1 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Potassium decreased | 0 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Amylase increased | 2 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Potassium increased | 0 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Urine blood | 0 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Urine protein | 0 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Sodium decreased | 0 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Hemoglobin | 0 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Gamma-glutamyl transferase increased | 4 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Partial thromboplastin time prolonged | 1 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Cholesterol increased | 0 participants |
| TPV OS 2-<6 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Glucose increased | 0 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Aspartate aminotransferase increased | 1 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Glucose increased | 0 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Gamma-glutamyl transferase increased | 4 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Neutrophil count decreased | 1 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Prothombin time prolonged | 1 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Amylase increased | 4 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Triglyceride increased | 1 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Urine protein | 0 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Calcium decreased | 2 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Potassium increased | 1 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Platelets | 0 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Hemoglobin | 0 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Cholesterol increased | 0 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Sodium increased | 3 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Creatinine phosphokinase increased | 1 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Calcium increased | 0 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Urine blood | 0 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Partial thromboplastin time prolonged | 0 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Alanine aminotransferase increased | 2 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Sodium decreased | 1 participants |
| TPV OS 6-<12 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Potassium decreased | 0 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Cholesterol increased | 1 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Creatinine phosphokinase increased | 3 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Gamma-glutamyl transferase increased | 2 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Sodium increased | 0 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Alanine aminotransferase increased | 0 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Amylase increased | 3 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Urine blood | 1 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Hemoglobin | 1 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Glucose increased | 1 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Triglyceride increased | 1 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Calcium decreased | 0 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Neutrophil count decreased | 1 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Prothombin time prolonged | 0 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Partial thromboplastin time prolonged | 0 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Sodium decreased | 0 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Potassium increased | 0 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Potassium decreased | 1 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Calcium increased | 1 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Aspartate aminotransferase increased | 0 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Platelets | 0 participants |
| TPV OS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Urine protein | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Urine blood | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Potassium decreased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Platelets | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Sodium decreased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Sodium increased | 4 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Creatinine phosphokinase increased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Calcium increased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Hemoglobin | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Urine protein | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Amylase increased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Partial thromboplastin time prolonged | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Triglyceride increased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Aspartate aminotransferase increased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Calcium decreased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Potassium increased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Gamma-glutamyl transferase increased | 2 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Glucose increased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Prothombin time prolonged | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Neutrophil count decreased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Alanine aminotransferase increased | 3 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Cholesterol increased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Cholesterol increased | 2 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Prothombin time prolonged | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Hemoglobin | 2 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Partial thromboplastin time prolonged | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Urine blood | 4 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Sodium decreased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Amylase increased | 1 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Platelets | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Potassium increased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Alanine aminotransferase increased | 6 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Creatinine phosphokinase increased | 10 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Potassium decreased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Sodium increased | 4 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Calcium increased | 2 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Gamma-glutamyl transferase increased | 3 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Urine protein | 1 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Triglyceride increased | 2 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Calcium decreased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Glucose increased | 2 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Aspartate aminotransferase increased | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation | Neutrophil count decreased | 0 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.
Time frame: up to 288 weeks
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Total with any severe drug-related adverse events | 2 participants |
| TPV OS 2-<6 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Gamma-glutamyl transferase increased | 1 participants |
| TPV OS 2-<6 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Alanine aminotransferase increased | 0 participants |
| TPV OS 2-<6 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Liver function test abnormal | 0 participants |
| TPV OS 2-<6 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Hepatic enzyme abnormal | 0 participants |
| TPV OS 2-<6 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Anemia | 0 participants |
| TPV OS 2-<6 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Nausea | 0 participants |
| TPV OS 2-<6 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Hyperamylasemia | 1 participants |
| TPV OS 6-<12 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Alanine aminotransferase increased | 1 participants |
| TPV OS 6-<12 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Anemia | 0 participants |
| TPV OS 6-<12 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Total with any severe drug-related adverse events | 6 participants |
| TPV OS 6-<12 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Liver function test abnormal | 1 participants |
| TPV OS 6-<12 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Gamma-glutamyl transferase increased | 2 participants |
| TPV OS 6-<12 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Hyperamylasemia | 0 participants |
| TPV OS 6-<12 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Hepatic enzyme abnormal | 1 participants |
| TPV OS 6-<12 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Nausea | 1 participants |
| TPV OS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Nausea | 0 participants |
| TPV OS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Hyperamylasemia | 0 participants |
| TPV OS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Liver function test abnormal | 0 participants |
| TPV OS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Anemia | 1 participants |
| TPV OS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Alanine aminotransferase increased | 0 participants |
| TPV OS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Gamma-glutamyl transferase increased | 2 participants |
| TPV OS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Total with any severe drug-related adverse events | 3 participants |
| TPV OS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Hepatic enzyme abnormal | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Gamma-glutamyl transferase increased | 2 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Alanine aminotransferase increased | 1 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Liver function test abnormal | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Hepatic enzyme abnormal | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Anemia | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Hyperamylasemia | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Total with any severe drug-related adverse events | 2 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Nausea | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Liver function test abnormal | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Hyperamylasemia | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Alanine aminotransferase increased | 4 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Nausea | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Total with any severe drug-related adverse events | 5 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Anemia | 0 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Gamma-glutamyl transferase increased | 1 participants |
| TPV SEDDS 12-18 Yrs | Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation | Hepatic enzyme abnormal | 0 participants |
Secondary
Baseline Median CD4+ Cell Count (Cells/mm3)
Time frame: baseline
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TPV OS 2-<6 Yrs | Baseline Median CD4+ Cell Count (Cells/mm3) | 795 cells/mm3 |
| TPV OS 6-<12 Yrs | Baseline Median CD4+ Cell Count (Cells/mm3) | 398 cells/mm3 |
| TPV OS 12-18 Yrs | Baseline Median CD4+ Cell Count (Cells/mm3) | 208 cells/mm3 |
| TPV SEDDS 12-18 Yrs | Baseline Median CD4+ Cell Count (Cells/mm3) | 330 cells/mm3 |
Secondary
Baseline Median Viral Load log10 Copies/mL
Time frame: baseline
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TPV OS 2-<6 Yrs | Baseline Median Viral Load log10 Copies/mL | 5.0 log10 copies/mL |
| TPV OS 6-<12 Yrs | Baseline Median Viral Load log10 Copies/mL | 4.6 log10 copies/mL |
| TPV OS 12-18 Yrs | Baseline Median Viral Load log10 Copies/mL | 5.1 log10 copies/mL |
| TPV SEDDS 12-18 Yrs | Baseline Median Viral Load log10 Copies/mL | 4.6 log10 copies/mL |
Secondary
Median Baseline CD4 Percent
Percentage of lymphocytes that are CD4 cells
Time frame: baseline
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TPV OS 2-<6 Yrs | Median Baseline CD4 Percent | 26 percentage of cells |
| TPV OS 6-<12 Yrs | Median Baseline CD4 Percent | 19 percentage of cells |
| TPV OS 12-18 Yrs | Median Baseline CD4 Percent | 12 percentage of cells |
| TPV SEDDS 12-18 Yrs | Median Baseline CD4 Percent | 19 percentage of cells |
Secondary
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward)
Time frame: baseline, week 100
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TPV OS 2-<6 Yrs | Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward) | 294 cells/mm3 |
| TPV OS 6-<12 Yrs | Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward) | 121 cells/mm3 |
| TPV OS 12-18 Yrs | Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward) | 12 cells/mm3 |
| TPV SEDDS 12-18 Yrs | Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward) | 45 cells/mm3 |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0.73ANOVA
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 0.79ANOVA
Secondary
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward)
Time frame: baseline, week 24
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TPV OS 2-<6 Yrs | Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward) | 293 cells/mm3 |
| TPV OS 6-<12 Yrs | Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward) | 133 cells/mm3 |
| TPV OS 12-18 Yrs | Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward) | 24 cells/mm3 |
| TPV SEDDS 12-18 Yrs | Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward) | 56 cells/mm3 |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0.64ANOVA
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 0.26ANOVA
Secondary
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward)
Time frame: baseline, week 48
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TPV OS 2-<6 Yrs | Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward) | 323 cells/mm3 |
| TPV OS 6-<12 Yrs | Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward) | 143 cells/mm3 |
| TPV OS 12-18 Yrs | Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward) | 21 cells/mm3 |
| TPV SEDDS 12-18 Yrs | Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward) | 39 cells/mm3 |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0.25ANOVA
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 0.7ANOVA
Secondary
Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward)
Percentage of lymphocytes that are CD4 cells
Time frame: baseline, week 100
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward) | 6 percentage of cells | — |
| TPV OS 6-<12 Yrs | Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward) | 4 percentage of cells | Inter-Quartile Range 0.9 |
| TPV OS 12-18 Yrs | Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward) | 1 percentage of cells | Inter-Quartile Range 0.7 |
| TPV SEDDS 12-18 Yrs | Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward) | 0 percentage of cells | — |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0.23ANOVA
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 0.23ANOVA
Secondary
Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward)
Percentage of lymphocytes that are CD4 cells
Time frame: baseline, week 24
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward) | 7 percentage of cells | — |
| TPV OS 6-<12 Yrs | Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward) | 4 percentage of cells | Inter-Quartile Range 0.8 |
| TPV OS 12-18 Yrs | Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward) | 1 percentage of cells | Inter-Quartile Range 0.4 |
| TPV SEDDS 12-18 Yrs | Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward) | 2 percentage of cells | — |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0.38ANOVA
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 0.2ANOVA
Secondary
Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward)
Percentage of lymphocytes that are CD4 cells
Time frame: baseline, week 48
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward) | 7 percentage of cells | — |
| TPV OS 6-<12 Yrs | Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward) | 5 percentage of cells | Inter-Quartile Range 0.8 |
| TPV OS 12-18 Yrs | Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward) | 1 percentage of cells | Inter-Quartile Range 0.5 |
| TPV SEDDS 12-18 Yrs | Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward) | 3 percentage of cells | — |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0.08ANOVA
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 0.36ANOVA
Secondary
Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward)
Time frame: baseline, week 100
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TPV OS 2-<6 Yrs | Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward) | -2.7 log10 copies/mL |
| TPV OS 6-<12 Yrs | Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward) | -1.2 log10 copies/mL |
| TPV OS 12-18 Yrs | Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward) | -0.2 log10 copies/mL |
| TPV SEDDS 12-18 Yrs | Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward) | -0.4 log10 copies/mL |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0ANOVA
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 0.69ANOVA
Secondary
Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward)
Time frame: baseline, week 24
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TPV OS 2-<6 Yrs | Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward) | -2.5 log10 copies/mL |
| TPV OS 6-<12 Yrs | Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward) | -1.7 log10 copies/mL |
| TPV OS 12-18 Yrs | Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward) | -0.4 log10 copies/mL |
| TPV SEDDS 12-18 Yrs | Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward) | -1.1 log10 copies/mL |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0.02ANOVA
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 0.47ANOVA
Secondary
Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward)
Time frame: baseline, week 48
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TPV OS 2-<6 Yrs | Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward) | -2.7 log10 copies/mL |
| TPV OS 6-<12 Yrs | Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward) | -1.0 log10 copies/mL |
| TPV OS 12-18 Yrs | Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward) | -0.4 log10 copies/mL |
| TPV SEDDS 12-18 Yrs | Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward) | -0.8 log10 copies/mL |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0ANOVA
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 0.81ANOVA
Secondary
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures)
Time frame: baseline, week 100
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures) | Viral load reduction | 14 participants |
| TPV OS 2-<6 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures) | No viral load reduction | 11 participants |
| TPV OS 6-<12 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures) | No viral load reduction | 24 participants |
| TPV OS 6-<12 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures) | Viral load reduction | 13 participants |
| TPV OS 12-18 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures) | Viral load reduction | 6 participants |
| TPV OS 12-18 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures) | No viral load reduction | 18 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures) | Viral load reduction | 7 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures) | No viral load reduction | 22 participants |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0.12Fisher Exact
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 1Fisher Exact
Secondary
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)
Time frame: baseline, week 24
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures) | Viral load reduction | 20 participants |
| TPV OS 2-<6 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures) | No viral load reduction | 5 participants |
| TPV OS 6-<12 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures) | No viral load reduction | 19 participants |
| TPV OS 6-<12 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures) | Viral load reduction | 18 participants |
| TPV OS 12-18 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures) | Viral load reduction | 9 participants |
| TPV OS 12-18 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures) | No viral load reduction | 15 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures) | Viral load reduction | 13 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures) | No viral load reduction | 16 participants |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0.02Fisher Exact
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 0.78Fisher Exact
Secondary
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures)
Time frame: baseline, week 48
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures) | Viral load reduction | 19 participants |
| TPV OS 2-<6 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures) | No viral load reduction | 6 participants |
| TPV OS 6-<12 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures) | No viral load reduction | 23 participants |
| TPV OS 6-<12 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures) | Viral load reduction | 14 participants |
| TPV OS 12-18 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures) | Viral load reduction | 8 participants |
| TPV OS 12-18 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures) | No viral load reduction | 16 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures) | Viral load reduction | 9 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures) | No viral load reduction | 20 participants |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0Fisher Exact
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 1Fisher Exact
Secondary
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16
Time frame: week 16
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16 | Non-compliance | 9 participants |
| TPV OS 2-<6 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16 | Compliance | 16 participants |
| TPV OS 6-<12 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16 | Non-compliance | 14 participants |
| TPV OS 6-<12 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16 | Compliance | 20 participants |
| TPV OS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16 | Compliance | 10 participants |
| TPV OS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16 | Non-compliance | 9 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16 | Compliance | 13 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16 | Non-compliance | 13 participants |
Secondary
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24
Time frame: week 24
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24 | Compliance | 17 participants |
| TPV OS 2-<6 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24 | Non-compliance | 8 participants |
| TPV OS 6-<12 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24 | Non-compliance | 17 participants |
| TPV OS 6-<12 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24 | Compliance | 17 participants |
| TPV OS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24 | Compliance | 6 participants |
| TPV OS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24 | Non-compliance | 10 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24 | Compliance | 14 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24 | Non-compliance | 11 participants |
Secondary
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48
Time frame: week 48
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48 | Compliance | 19 participants |
| TPV OS 2-<6 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48 | Non-compliance | 5 participants |
| TPV OS 6-<12 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48 | Non-compliance | 18 participants |
| TPV OS 6-<12 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48 | Compliance | 11 participants |
| TPV OS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48 | Compliance | 5 participants |
| TPV OS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48 | Non-compliance | 8 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48 | Compliance | 11 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48 | Non-compliance | 11 participants |
Secondary
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8
Time frame: week 8
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8 | Compliance | 16 participants |
| TPV OS 2-<6 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8 | Non-compliance | 8 participants |
| TPV OS 6-<12 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8 | Non-compliance | 13 participants |
| TPV OS 6-<12 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8 | Compliance | 21 participants |
| TPV OS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8 | Compliance | 13 participants |
| TPV OS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8 | Non-compliance | 8 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8 | Compliance | 10 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8 | Non-compliance | 18 participants |
Secondary
Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures)
Time frame: baseline, week 100
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures) | Viral load reduction | 14 participants |
| TPV OS 2-<6 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures) | No viral load reduction | 11 participants |
| TPV OS 6-<12 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures) | No viral load reduction | 26 participants |
| TPV OS 6-<12 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures) | Viral load reduction | 11 participants |
| TPV OS 12-18 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures) | Viral load reduction | 6 participants |
| TPV OS 12-18 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures) | No viral load reduction | 18 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures) | Viral load reduction | 7 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures) | No viral load reduction | 22 participants |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0.06Fisher Exact
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 1Fisher Exact
Secondary
Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures)
Time frame: baseline, week 24
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures) | Viral load reduction | 16 participants |
| TPV OS 2-<6 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures) | No viral load reduction | 9 participants |
| TPV OS 6-<12 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures) | No viral load reduction | 22 participants |
| TPV OS 6-<12 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures) | Viral load reduction | 15 participants |
| TPV OS 12-18 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures) | Viral load reduction | 8 participants |
| TPV OS 12-18 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures) | No viral load reduction | 16 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures) | Viral load reduction | 10 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures) | No viral load reduction | 19 participants |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0.12Fisher Exact
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 1Fisher Exact
Secondary
Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures)
Time frame: baseline, week 48
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures) | Viral load reduction | 18 participants |
| TPV OS 2-<6 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures) | No viral load reduction | 7 participants |
| TPV OS 6-<12 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures) | No viral load reduction | 24 participants |
| TPV OS 6-<12 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures) | Viral load reduction | 13 participants |
| TPV OS 12-18 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures) | Viral load reduction | 8 participants |
| TPV OS 12-18 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures) | No viral load reduction | 16 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures) | Viral load reduction | 9 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures) | No viral load reduction | 20 participants |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0.01Fisher Exact
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 1Fisher Exact
Secondary
Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures)
Time frame: baseline, week 100
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures) | Viral load reduction | 12 participants |
| TPV OS 2-<6 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures) | No viral load reduction | 13 participants |
| TPV OS 6-<12 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures) | No viral load reduction | 26 participants |
| TPV OS 6-<12 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures) | Viral load reduction | 11 participants |
| TPV OS 12-18 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures) | Viral load reduction | 5 participants |
| TPV OS 12-18 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures) | No viral load reduction | 19 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures) | Viral load reduction | 6 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures) | No viral load reduction | 23 participants |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0.18Fisher Exact
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 1Fisher Exact
Secondary
Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures)
Time frame: baseline, week 24
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures) | Viral load reduction | 10 participants |
| TPV OS 2-<6 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures) | No viral load reduction | 15 participants |
| TPV OS 6-<12 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures) | No viral load reduction | 25 participants |
| TPV OS 6-<12 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures) | Viral load reduction | 12 participants |
| TPV OS 12-18 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures) | Viral load reduction | 6 participants |
| TPV OS 12-18 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures) | No viral load reduction | 18 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures) | Viral load reduction | 8 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures) | No viral load reduction | 21 participants |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0.6Fisher Exact
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 1Fisher Exact
Secondary
Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures)
Time frame: baseline, week 48
Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TPV OS 2-<6 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures) | Viral load reduction | 13 participants |
| TPV OS 2-<6 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures) | No viral load reduction | 12 participants |
| TPV OS 6-<12 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures) | No viral load reduction | 24 participants |
| TPV OS 6-<12 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures) | Viral load reduction | 13 participants |
| TPV OS 12-18 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures) | Viral load reduction | 6 participants |
| TPV OS 12-18 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures) | No viral load reduction | 18 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures) | Viral load reduction | 8 participants |
| TPV SEDDS 12-18 Yrs | Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures) | No viral load reduction | 21 participants |
Comparison: Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrsp-value: 0.2Fisher Exact
Comparison: Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrsp-value: 1Fisher Exact