- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
-
Antella (fi), Italien
- 1182.107.39001 Boehringer Ingelheim Investigational Site
-
Bari, Italien
- 1182.107.39009 Boehringer Ingelheim Investigational Site
-
Ferrara, Italien
- 1182.107.39007 Boehringer Ingelheim Investigational Site
-
Palermo, Italien
- 1182.107.39011 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Barcelona, Spanien
- 1182.107.34001 Boehringer Ingelheim Investigational Site
-
Barcelona, Spanien
- 1182.107.34002 Boehringer Ingelheim Investigational Site
-
L'Hospitalet de Llobregat, Spanien
- 1182.107.34003 Boehringer Ingelheim Investigational Site
-
Madrid, Spanien
- 1182.107.34004 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Berlin, Tyskland
- 1182.107.49002 Boehringer Ingelheim Investigational Site
-
Berlin, Tyskland
- 1182.107.49004 Boehringer Ingelheim Investigational Site
-
Frankfurt/Main, Tyskland
- 1182.107.49003 Boehringer Ingelheim Investigational Site
-
München, Tyskland
- 1182.107.49001 Boehringer Ingelheim Investigational Site
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Interventionel model: Parallel tildeling
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))
Tidsramme: Baseline (Day 0) to Final (Day 14)
|
Baseline (Day 0) to Final (Day 14)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Apparent Oral Clearance I(Cl/F) of Tipranavir
Tidsramme: Final (Day 14)
|
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.
|
Final (Day 14)
|
Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID)
Tidsramme: Final (Day 13 for QD, Day 14 for BID)
|
Tipranavir (TPV) pharmacokinetics
|
Final (Day 13 for QD, Day 14 for BID)
|
Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID
Tidsramme: Final (Day 13 for QD, Day 14 for BID)
|
TPV pharmacokinetics
|
Final (Day 13 for QD, Day 14 for BID)
|
Trough Concentration (Cmin) of Tipranavir
Tidsramme: Final (Day 13 for QD, Day 14 for BID)
|
TPV pharmacokinetics
|
Final (Day 13 for QD, Day 14 for BID)
|
Maximum Concentration (Cmax) of Tipranavir
Tidsramme: Final (Day 13 for QD, Day 14 for BID)
|
TPV pharmacokinetics
|
Final (Day 13 for QD, Day 14 for BID)
|
Volume of Distribution (V/F) of Tipranavir
Tidsramme: Final (Day 14)
|
Tipranavir pharmacokinetics
|
Final (Day 14)
|
Terminal Half-Life (t1/2) of Tipranavir
Tidsramme: Final (Day 14)
|
Tipranavir pharmacokinetics
|
Final (Day 14)
|
Time to Cmax (Tmax) of Tipranavir
Tidsramme: Final (Day 14)
|
Tipranavir pharmacokinetics
|
Final (Day 14)
|
AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID
Tidsramme: Final (Day 13 for QD, Day 14 for BID)
|
Ritonavir pharmacokinetics
|
Final (Day 13 for QD, Day 14 for BID)
|
Cp 24 h of Ritonavir for QD and CP 12 h of Ritonavir for BID
Tidsramme: Final (Day 13 for QD, Day 14 for BID)
|
Ritonavir pharmacokinetics
|
Final (Day 13 for QD, Day 14 for BID)
|
Apparent Oral Clearance I(Cl/F) of Ritonavir
Tidsramme: Final (Day 13 for QD, Day 14 for BID)
|
Ritonavir pharmacokinetics
|
Final (Day 13 for QD, Day 14 for BID)
|
Volume of Distribution (V/F) of Ritonavir
Tidsramme: Final (Day 14)
|
Ritonavir pharmacokinetics
|
Final (Day 14)
|
Terminal Half-Life (t1/2) of Ritonavir
Tidsramme: Final (Day 14)
|
Ritonavir pharmacokinetics
|
Final (Day 14)
|
Tmax of Ritonavir
Tidsramme: Final (Day 14)
|
Ritonavir pharmacokinetics
|
Final (Day 14)
|
Cmax of Ritonavir
Tidsramme: Visits baseline, 5, 7, 9 and 13 or 14
|
Ritonavir pharmacokinetics
|
Visits baseline, 5, 7, 9 and 13 or 14
|
Clinical Abnormal Findings in Laboratory and Physical Examination
Tidsramme: Screening through the end of the study (14 days)
|
Screening through the end of the study (14 days)
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Sygdomme i immunsystemet
- HIV-infektioner
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Anti-HIV-midler
- Anti-retrovirale midler
- Proteasehæmmere
- Cytokrom P-450 CYP3A-hæmmere
- Cytokrom P-450 enzymhæmmere
- HIV-proteasehæmmere
- Virale proteasehæmmere
- Ritonavir
- Tipranavir
Andre undersøgelses-id-numre
- 1182.107
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med HIV-infektioner
-
University of Santiago de CompostelaOsteology FoundationRekruttering
-
Institut PasteurRekruttering
-
Universidad del DesarrolloAfsluttetHealthcare Associated InfectionChile
-
The University of Texas Health Science Center,...EurofinsAfsluttetOdontogen Deep Space Neck InfectionForenede Stater
-
Imelda Hospital, BonheidenAfsluttetHealthcare Associated InfectionBelgien
-
Centre Hospitalier Universitaire de NīmesRekrutteringÆldre | Healthcare Associated InfectionFrankrig
-
Centre Hospitalier Universitaire, AmiensAfsluttetHealthcare Associated Infection | IglerFrankrig
-
University of PennsylvaniaAfsluttetAntimikrobiel resistensForenede Stater, Botswana
-
University of Maryland, BaltimoreVA Office of Research and DevelopmentAfsluttetMenneskelig mikrobiomForenede Stater
-
Universidad Autonoma de Nuevo LeonUkendtSundhedsrelaterede infektioner
Kliniske forsøg med tipranavir
-
Boehringer IngelheimAfsluttet
-
Boehringer IngelheimAfsluttet
-
Boehringer IngelheimAfsluttetHIV-infektionerForenede Stater, Puerto Rico
-
Boehringer IngelheimAfsluttet
-
Boehringer IngelheimAfsluttet
-
Boehringer IngelheimAfsluttet
-
Boehringer IngelheimAfsluttet
-
Boehringer IngelheimAfsluttet
-
Germans Trias i Pujol HospitalFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y...Afsluttet
-
Boehringer IngelheimAfsluttetHIV-infektionerForenede Stater, Argentina, Brasilien, Frankrig, Tyskland, Italien, Spanien