- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00076999
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
Multiple-dose, Open-label, Randomized, Safety and Pharmacokinetic Study of Tipranavir in Combination With Low-dose Ritonavir in HIV-infected Pediatric Patients
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
-
Capital Federal, Argentinien
- 1182.14.5401 Fundación Huésped
-
-
-
-
-
São Paulo, Brasilien
- 1182.14.55002
-
São Paulo, Brasilien
- 1182.14.55003
-
-
-
-
-
Berlin, Deutschland
- 1182.14.49002 Boehringer Ingelheim Investigational Site
-
Frankfurt/Main, Deutschland
- 1182.14.49001 Boehringer Ingelheim Investigational Site
-
München, Deutschland
- 1182.14.49004 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Lyon cedex 3, Frankreich
- 1182.14.33004 Boehringer Ingelheim Investigational Site
-
Nantes cedex 1, Frankreich
- 1182.14.33005 Boehringer Ingelheim Investigational Site
-
Paris, Frankreich
- 1182.14.33002 Boehringer Ingelheim Investigational Site
-
Paris cedex 12, Frankreich
- 1182.14.33006 Boehringer Ingelheim Investigational Site
-
Paris cedex 14, Frankreich
- 1182.14.33003 Boehringer Ingelheim Investigational Site
-
Paris cedex 15, Frankreich
- 1182.14.33001 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Padova, Italien
- 1182.14.39001 Boehringer Ingelheim Investigational Site
-
Roma, Italien
- 1182.14.39003 Boehringer Ingelheim Investigational Site
-
-
-
-
Ontario
-
Toronto, Ontario, Kanada
- 1182.14.11002 Boehringer Ingelheim Investigational Site
-
-
Quebec
-
Montreal, Quebec, Kanada
- 1182.14.11001 Boehringer Ingelheim Investigational Site
-
-
-
-
-
México, D.F., Mexiko
- 1182.14.52001 CLINDI (Clínica de Inmunodeficiencias)
-
México, D.F., Mexiko
- 1182.14.52002
-
-
-
-
-
San Juan, Puerto Rico
- 1182.14.00005 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Barcelona, Spanien
- 1182.14.34002 Boehringer Ingelheim Investigational Site
-
Madrid, Spanien
- 1182.14.34001 Boehringer Ingelheim Investigational Site
-
-
-
-
California
-
Los Angeles, California, Vereinigte Staaten
- 1182.14.00001 Boehringer Ingelheim Investigational Site
-
Los Angeles, California, Vereinigte Staaten
- 1182.14.00006 Boehringer Ingelheim Investigational Site
-
-
Connecticut
-
Hartford, Connecticut, Vereinigte Staaten
- 1182.14.00010 Boehringer Ingelheim Investigational Site
-
-
Illinois
-
Chicago, Illinois, Vereinigte Staaten
- 1182.14.00004 Boehringer Ingelheim Investigational Site
-
-
Massachusetts
-
North Worcester, Massachusetts, Vereinigte Staaten
- 1182.14.00008 Boehringer Ingelheim Investigational Site
-
Springfield, Massachusetts, Vereinigte Staaten
- 1182.14.00009 Boehringer Ingelheim Investigational Site
-
-
Ohio
-
Cleveland, Ohio, Vereinigte Staaten
- 1182.14.00002 Boehringer Ingelheim Investigational Site
-
-
Tennessee
-
Memphis, Tennessee, Vereinigte Staaten
- 1182.14.00007 Boehringer Ingelheim Investigational Site
-
-
Texas
-
Houston, Texas, Vereinigte Staaten
- 1182.14.00003 Boehringer Ingelheim Investigational Site
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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:
Grade 2 gamma-glutamyl transferase Grade 2 cholesterol Grade 2 triglycerides
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: TPV/r 290/115 mg/m^2
TPV and RTV oral solution low dose
|
Tipranavir oral solution
Ritonavir oral solution
|
Experimental: TPV/r 375/150 mg/m^2
TPV and RTV oral solution high dose
|
Tipranavir oral solution
Ritonavir oral solution
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
Zeitfenster: 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.
|
up to 288 weeks
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Zeitfenster: 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.
|
up to 288 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)
Zeitfenster: baseline, week 24
|
baseline, week 24
|
|
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures)
Zeitfenster: baseline, week 48
|
baseline, week 48
|
|
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures)
Zeitfenster: baseline, week 100
|
baseline, week 100
|
|
Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures)
Zeitfenster: baseline, week 24
|
baseline, week 24
|
|
Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures)
Zeitfenster: baseline, week 48
|
baseline, week 48
|
|
Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures)
Zeitfenster: baseline, week 100
|
baseline, week 100
|
|
Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures)
Zeitfenster: baseline, week 24
|
baseline, week 24
|
|
Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures)
Zeitfenster: baseline, week 48
|
baseline, week 48
|
|
Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures)
Zeitfenster: baseline, week 100
|
baseline, week 100
|
|
Baseline Median Viral Load log10 Copies/mL
Zeitfenster: baseline
|
baseline
|
|
Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward)
Zeitfenster: baseline, week 24
|
baseline, week 24
|
|
Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward)
Zeitfenster: baseline, week 48
|
baseline, week 48
|
|
Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward)
Zeitfenster: baseline, week 100
|
baseline, week 100
|
|
Baseline Median CD4+ Cell Count (Cells/mm3)
Zeitfenster: baseline
|
baseline
|
|
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward)
Zeitfenster: baseline, week 24
|
baseline, week 24
|
|
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward)
Zeitfenster: baseline, week 48
|
baseline, week 48
|
|
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward)
Zeitfenster: baseline, week 100
|
baseline, week 100
|
|
Median Baseline CD4 Percent
Zeitfenster: baseline
|
Percentage of lymphocytes that are CD4 cells
|
baseline
|
Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward)
Zeitfenster: baseline, week 24
|
Percentage of lymphocytes that are CD4 cells
|
baseline, week 24
|
Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward)
Zeitfenster: baseline, week 48
|
Percentage of lymphocytes that are CD4 cells
|
baseline, week 48
|
Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward)
Zeitfenster: baseline, week 100
|
Percentage of lymphocytes that are CD4 cells
|
baseline, week 100
|
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8
Zeitfenster: week 8
|
week 8
|
|
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16
Zeitfenster: week 16
|
week 16
|
|
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24
Zeitfenster: week 24
|
week 24
|
|
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48
Zeitfenster: week 48
|
week 48
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- HIV-Infektionen
- Pharmazeutische Lösungen
Andere Studien-ID-Nummern
- 1182.14
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur HIV-Infektionen
-
Duke UniversityAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Vereinigte Staaten
-
Catholic University of the Sacred HeartAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
Abbott Medical DevicesThoratec CorporationAbgeschlossenDriveline Heart-assisted Device Related InfectionVereinigte Staaten
-
Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekrutierungCentral Line-associated Bloodstream Infection (CLABSI)Niederlande
-
University of MalayaTeleflexRekrutierungCLABSI – Central Line Associated Bloodstream InfectionMalaysia
-
National Taiwan University Hospital Hsin-Chu BranchAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
Johns Hopkins UniversityAbgeschlossenCLABSI – Central Line Associated Bloodstream InfectionVereinigte Staaten
-
National Taiwan University HospitalAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Taiwan
-
University of ZurichNoch keine RekrutierungCentral Line-associated Bloodstream Infection (CLABSI) | Katheterbedingte Blutstrominfektion
-
Princess Anna Mazowiecka Hospital, Warsaw, PolandNutricia FoundationAktiv, nicht rekrutierendWachstumsfehler | CLABSI – Central Line Associated Bloodstream InfectionPolen
Klinische Studien zur TPV oral solution
-
Medtronic Heart ValvesAbgeschlossenFallot-Tetralogie | Angeborenen HerzfehlerVereinigte Staaten, Kanada
-
Taewoong Medical Co., Ltd.AvaniaAktiv, nicht rekrutierendHerzkrankheiten | Fallot-Tetralogie | Pulmonalklappenstenose | PulmonalklappeninsuffizienzDeutschland, Spanien, Korea, Republik von, Italien, Niederlande, Truthahn
-
Seoul National University HospitalAbgeschlossenHerz-Kreislauf-Anomalien | Pulmonalklappeninsuffizienz | Pulmonalklappenstenose | Angeborene HerzfehlerKorea, Republik von
-
Santen Inc.AbgeschlossenOffenwinkelglaukom, okuläre HypertonieVereinigte Staaten, Japan
-
University of California, Los AngelesAbgeschlossenEisenmenger-SyndromVereinigte Staaten
-
Boehringer IngelheimAbgeschlossen
-
Taewoong Medical Co., Ltd.Aktiv, nicht rekrutierendPulmonalklappenstenose | Angeborener Herzfehler | Pulmonalklappe; Insuffizienz, angeborenKorea, Republik von