- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00530920
Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients
A Multicenter, Randomized, Open Label, Clinical Trial to Evaluate Three Doses of Tipranavir Boosted With Ritonavir (500 mg/200 mg qd, 250 mg/100 mg Bid and 500 mg/100 mg Bid) by Assessing the Steady-state Pharmacokinetics and Short-term Efficacy and Safety in HIV-1 Positive Treatment naïve Patients
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Berlin, Deutschland
- 1182.107.49002 Boehringer Ingelheim Investigational Site
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Berlin, Deutschland
- 1182.107.49004 Boehringer Ingelheim Investigational Site
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Frankfurt/Main, Deutschland
- 1182.107.49003 Boehringer Ingelheim Investigational Site
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München, Deutschland
- 1182.107.49001 Boehringer Ingelheim Investigational Site
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Antella (fi), Italien
- 1182.107.39001 Boehringer Ingelheim Investigational Site
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Bari, Italien
- 1182.107.39009 Boehringer Ingelheim Investigational Site
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Ferrara, Italien
- 1182.107.39007 Boehringer Ingelheim Investigational Site
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Palermo, Italien
- 1182.107.39011 Boehringer Ingelheim Investigational Site
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Barcelona, Spanien
- 1182.107.34001 Boehringer Ingelheim Investigational Site
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Barcelona, Spanien
- 1182.107.34002 Boehringer Ingelheim Investigational Site
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L'Hospitalet de Llobregat, Spanien
- 1182.107.34003 Boehringer Ingelheim Investigational Site
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Madrid, Spanien
- 1182.107.34004 Boehringer Ingelheim Investigational Site
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation.
- HIV-1 infected men and non-pregnant women who are treatment naïve, with positive serology (EIA) confirmed by Western blot.
- Age > 18 and < 65 years.
- CD4 > 200 cells/mm3
- Viral load (HIV-1 mRNA viral load) > 5,000 copies/mL.
- Ability to swallow multiple large capsules without difficulty.
- Acceptable laboratory values that indicate adequate baseline organ function at screening visit.
- Laboratory values are considered to be acceptable if the severity of any parameter is = < Grade 2, based on the DAIDS/ACTG Grading Scale (see Appendix 10.2).
- Acceptable medical history, physical examination, and 12-lead ECG at screening
Willingness to abstain from the following starting 2 weeks prior to administration of any study medication and up until the end of the study:
o Grapefruit or grapefruit juice, Seville oranges, St. John's Wort, and Milk Thistle.
- Willingness to abstain from alcohol 3 days prior to administration of any study medication up to the end of the study.
Willingness to abstain from the following starting 3 days prior to PK sampling:
o Garlic supplements and methylxanthine containing foods or drinks (including coffee, tea, cola, energy drinks, chocolate, etc.).
- Willingness to abstain from over-the-counter herbal medications for the duration of the study.
- Willingness to abstain from any over the counter medication 7 days prior to administration of any study medication (including vitamins, minerals, dietary supplements and antacids) during the study until completion of the post study assessments.
Exclusion Criteria:
Female patients of reproductive potential who:
- Have positive serum pregnancy test.
- Have not been using a barrier method of contraception for at least 3 months prior to participation in the study.
- Are not willing to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and 60 days after completion/termination of the trial.
- Are breast-feeding.
- Suspected or documented seroconversion within last 6 months
- Participation in another trial with an investigational medicine within 2 months prior to Day 0 of this study.
- Use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month prior to Day 0 and for the duration of the study.
- Use of hormone replacement therapy within 1 month prior to Day 0 and anytime during the study.
- History of acute illness within 30 days prior to Day 0.
- Have evidence of active or acute HBV or HCV.
- Alcohol or substance abuse within 1 year prior to screening or during the study.
- Patients with a history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering TPV.
- Patients who have taken (within 7 days prior to Day 0) any over-the-counter or prescription medication that, in the opinion of the investigator in consultation with the BI clinical monitor, might interfere with absorption, distribution, or metabolism of the study medications.
- Known hypersensitivity to any ingredients of the test drug.
- Inability to adhere to the protocol.
- Genotypic resistance to tipranavir (defined as a TPV mutation score > 4).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Interventionsmodell: Parallele Zuordnung
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))
Zeitfenster: Baseline (Day 0) to Final (Day 14)
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Baseline (Day 0) to Final (Day 14)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Apparent Oral Clearance I(Cl/F) of Tipranavir
Zeitfenster: Final (Day 14)
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Tipranavir pharmacokinetics - Clearance (CL) is defined as the dose of a drug divided by the area-under-the-concentration-time curve (AUC), ie.
CL = Dose / AUC.
For extravascu-lar models the fraction of dose absorbed cannot be estimated, therefore "clear-ance" for these models is actually Cl/F where F is the fraction of the drug dose which is absorbed.
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Final (Day 14)
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Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID)
Zeitfenster: Final (Day 13 for QD, Day 14 for BID)
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Tipranavir (TPV) pharmacokinetics
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Final (Day 13 for QD, Day 14 for BID)
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Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID
Zeitfenster: Final (Day 13 for QD, Day 14 for BID)
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TPV pharmacokinetics
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Final (Day 13 for QD, Day 14 for BID)
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Trough Concentration (Cmin) of Tipranavir
Zeitfenster: Final (Day 13 for QD, Day 14 for BID)
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TPV pharmacokinetics
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Final (Day 13 for QD, Day 14 for BID)
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Maximum Concentration (Cmax) of Tipranavir
Zeitfenster: Final (Day 13 for QD, Day 14 for BID)
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TPV pharmacokinetics
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Final (Day 13 for QD, Day 14 for BID)
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Volume of Distribution (V/F) of Tipranavir
Zeitfenster: Final (Day 14)
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Tipranavir pharmacokinetics
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Final (Day 14)
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Terminal Half-Life (t1/2) of Tipranavir
Zeitfenster: Final (Day 14)
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Tipranavir pharmacokinetics
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Final (Day 14)
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Time to Cmax (Tmax) of Tipranavir
Zeitfenster: Final (Day 14)
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Tipranavir pharmacokinetics
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Final (Day 14)
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AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID
Zeitfenster: Final (Day 13 for QD, Day 14 for BID)
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Ritonavir pharmacokinetics
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Final (Day 13 for QD, Day 14 for BID)
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Cp 24 h of Ritonavir for QD and CP 12 h of Ritonavir for BID
Zeitfenster: Final (Day 13 for QD, Day 14 for BID)
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Ritonavir pharmacokinetics
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Final (Day 13 for QD, Day 14 for BID)
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Apparent Oral Clearance I(Cl/F) of Ritonavir
Zeitfenster: Final (Day 13 for QD, Day 14 for BID)
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Ritonavir pharmacokinetics
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Final (Day 13 for QD, Day 14 for BID)
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Volume of Distribution (V/F) of Ritonavir
Zeitfenster: Final (Day 14)
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Ritonavir pharmacokinetics
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Final (Day 14)
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Terminal Half-Life (t1/2) of Ritonavir
Zeitfenster: Final (Day 14)
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Ritonavir pharmacokinetics
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Final (Day 14)
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Tmax of Ritonavir
Zeitfenster: Final (Day 14)
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Ritonavir pharmacokinetics
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Final (Day 14)
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Cmax of Ritonavir
Zeitfenster: Visits baseline, 5, 7, 9 and 13 or 14
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Ritonavir pharmacokinetics
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Visits baseline, 5, 7, 9 and 13 or 14
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Clinical Abnormal Findings in Laboratory and Physical Examination
Zeitfenster: Screening through the end of the study (14 days)
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Screening through the end of the study (14 days)
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
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
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Enzym-Inhibitoren
- Anti-HIV-Agenten
- Antiretrovirale Mittel
- Protease-Inhibitoren
- Cytochrom P-450 CYP3A-Inhibitoren
- Cytochrom-P-450-Enzym-Inhibitoren
- HIV-Protease-Inhibitoren
- Virale Protease-Inhibitoren
- Ritonavir
- Tipranavir
Andere Studien-ID-Nummern
- 1182.107
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