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Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children

25 aprile 2014 aggiornato da: Boehringer Ingelheim

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

115

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Argentina
      • Capital Federal, Argentina
        • 1182.14.5401 Fundación Huésped
  • Brasile
      • São Paulo, Brasile
        • 1182.14.55002
      • São Paulo, Brasile
        • 1182.14.55003
  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • 1182.14.11002 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 1182.14.11001 Boehringer Ingelheim Investigational Site
  • Francia
      • Lyon cedex 3, Francia
        • 1182.14.33004 Boehringer Ingelheim Investigational Site
      • Nantes cedex 1, Francia
        • 1182.14.33005 Boehringer Ingelheim Investigational Site
      • Paris, Francia
        • 1182.14.33002 Boehringer Ingelheim Investigational Site
      • Paris cedex 12, Francia
        • 1182.14.33006 Boehringer Ingelheim Investigational Site
      • Paris cedex 14, Francia
        • 1182.14.33003 Boehringer Ingelheim Investigational Site
      • Paris cedex 15, Francia
        • 1182.14.33001 Boehringer Ingelheim Investigational Site
  • Germania
      • Berlin, Germania
        • 1182.14.49002 Boehringer Ingelheim Investigational Site
      • Frankfurt/Main, Germania
        • 1182.14.49001 Boehringer Ingelheim Investigational Site
      • München, Germania
        • 1182.14.49004 Boehringer Ingelheim Investigational Site
  • Italia
      • Padova, Italia
        • 1182.14.39001 Boehringer Ingelheim Investigational Site
      • Roma, Italia
        • 1182.14.39003 Boehringer Ingelheim Investigational Site
  • Messico
      • México, D.F., Messico
        • 1182.14.52001 CLINDI (Clínica de Inmunodeficiencias)
      • México, D.F., Messico
        • 1182.14.52002
  • Porto Rico
      • San Juan, Porto Rico
        • 1182.14.00005 Boehringer Ingelheim Investigational Site
  • Spagna
      • Barcelona, Spagna
        • 1182.14.34002 Boehringer Ingelheim Investigational Site
      • Madrid, Spagna
        • 1182.14.34001 Boehringer Ingelheim Investigational Site
  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti
        • 1182.14.00001 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, Stati Uniti
        • 1182.14.00006 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Hartford, Connecticut, Stati Uniti
        • 1182.14.00010 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, Stati Uniti
        • 1182.14.00004 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • North Worcester, Massachusetts, Stati Uniti
        • 1182.14.00008 Boehringer Ingelheim Investigational Site
      • Springfield, Massachusetts, Stati Uniti
        • 1182.14.00009 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cleveland, Ohio, Stati Uniti
        • 1182.14.00002 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Memphis, Tennessee, Stati Uniti
        • 1182.14.00007 Boehringer Ingelheim Investigational Site
    • Texas
      • Houston, Texas, Stati Uniti
        • 1182.14.00003 Boehringer Ingelheim Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 2 anni a 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: TPV/r 290/115 mg/m^2
TPV and RTV oral solution low dose
Droga: TPV oral solution
Tipranavir oral solution
Droga: RTV oral solution
Ritonavir oral solution
Sperimentale: TPV/r 375/150 mg/m^2
TPV and RTV oral solution high dose
Droga: TPV oral solution
Tipranavir oral solution
Droga: RTV oral solution
Ritonavir oral solution

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: baseline, week 100
baseline, week 100
Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures)
Lasso di tempo: baseline, week 24
baseline, week 24
Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures)
Lasso di tempo: baseline, week 48
baseline, week 48
Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures)
Lasso di tempo: baseline, week 100
baseline, week 100
Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures)
Lasso di tempo: baseline, week 24
baseline, week 24
Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures)
Lasso di tempo: baseline, week 48
baseline, week 48
Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures)
Lasso di tempo: baseline, week 100
baseline, week 100
Baseline Median Viral Load log10 Copies/mL
Lasso di tempo: baseline
baseline
Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward)
Lasso di tempo: baseline, week 24
baseline, week 24
Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward)
Lasso di tempo: baseline, week 48
baseline, week 48
Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward)
Lasso di tempo: baseline, week 100
baseline, week 100
Baseline Median CD4+ Cell Count (Cells/mm3)
Lasso di tempo: baseline
baseline
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward)
Lasso di tempo: baseline, week 24
baseline, week 24
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward)
Lasso di tempo: baseline, week 48
baseline, week 48
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward)
Lasso di tempo: baseline, week 100
baseline, week 100
Median Baseline CD4 Percent
Lasso di tempo: baseline
Percentage of lymphocytes that are CD4 cells
baseline
Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: week 8
week 8
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16
Lasso di tempo: week 16
week 16
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24
Lasso di tempo: week 24
week 24
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48
Lasso di tempo: week 48
week 48

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boehringer Ingelheim

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2003

Completamento primario (Effettivo)

1 giugno 2010

Date di iscrizione allo studio

Primo inviato

9 febbraio 2004

Primo inviato che soddisfa i criteri di controllo qualità

9 febbraio 2004

Primo Inserito (Stima)

10 febbraio 2004

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

12 maggio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 aprile 2014

Ultimo verificato

1 aprile 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1182.14

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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