- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01090648
TMC125HIV1083 - Swallowability of Uncoated 200 mg Etravirine Tablets in HIV-1 Infected Patients
10. desember 2012 oppdatert av: Tibotec Pharmaceuticals, Ireland
A Study to Survey the Swallowability of Uncoated 200-mg Tablets of Etravirine in HIV-1 Infected Subjects
This trial is designed to assess the swallowability of uncoated and film-coated 200 mg etravirine tablets in HIV-1 infected patients.
In addition, comparisons between a single 200 mg tablet versus two 100 mg formulations will be made.
The outcome of the trial will aid in making decisions about the future commercial 200 mg formulation.
Studieoversikt
Detaljert beskrivelse
This trial is designed to elicit the swallowability of two formulations of 200 mg tablets of etravirine (ETR).
The trial will allow the assessment of the swallowability of the 200 mg uncoated tablet, the 200 mg film-coated tablet and make comparisons between these tablets and with the current commercially available 100 mg (uncoated) tablets.
The trial will be performed in HIV-1 infected patients who are currently taking etravirine (ETR) at a total daily dose of 400 mg (four 100 mg tablets, as whole tablets orally) as part of an antiretroviral regimen with virologic suppression (< 50 copies/mL for at least three months).
The trial includes only patients who are already taking etravirine since these patients will have pill taking experience and will also have experience with the commercially available 100 mg tablet formulation.
A minimum of 45 patients will be included in the trial to assure a sample representative of the HIV-1 infected population.
Patients will be given a single dose of the etravirine (ETR) uncoated 200 mg tablet in the morning, and then complete a questionnaire related to that intake.
Within 30 minutes, they will be administered the coated 200 mg formulation, followed by a questionnaire.
Assessments of the 200 mg tablets will be made in a single-blinded fashion.
As the patient will be administered two 200mg tablets in the morning, he/she does not need to take an evening dose on the day of these assessments.
The questionnaire will be used to assess swallowability of the 200 mg formulations and of their current 100 mg tablets, and will also evaluate patient preferences.
Patients will be followed up for safety and tolerability for one week due to the short duration the patient will be on study treatment; it will be difficult to distinguish between Adverse Events (AEs) resulting from their current etravirine (ETR) intake (four 100 mg tablets) versus the study intake (two 200 mg tablets).
A single dose of an etravirine uncoated 200 mg tablet in the morning, followed by completion of a questionnaire related to that intake.
Within 30 minutes, patients will be administered the coated 200 mg formulation, again followed by a questionnaire.
Maximum 2 weeks screening, 1 day treatment, 1 week follow up.
Total duration of participation is 2 weeks maximum.
Studietype
Intervensjonell
Registrering (Faktiske)
49
Fase
- Fase 1
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Women must be postmenopausal for at least 2 years, OR be surgically sterile (have had a total hysterectomy or bilateral oophorectomy, tubal ligation/bilateral tubal clips without reversal operation, or otherwise be incapable of becoming pregnant), OR be not heterosexually active for the duration of the study or have a vasectomized partner (confirmed sterile) OR if of childbearing potential and heterosexually active, be practicing a highly effective method of birth control (as specified below) before entry, and agree to continue to use a highly effective method of contraception throughout the study. Women with tubal ligation are required to use one contraceptive method (Note: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction)
- All women must have a negative serum or urine pregnancy test at screening. Women of childbearing potential must have a negative urine pregnancy test at other visits
- Men must agree to use a highly effective method of birth control (i.e., male condom with either female intrauterine device, diaphragm, cervical cap or non-estrogen hormonal based contraceptives) and to not donate sperm during the study
- Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Patient can comply with the protocol requirements
Exclusion Criteria:
- Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the patient or prevent the patient from meeting or performing study requirements
- Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings during screening of medical history, laboratory or physical examination that, in the investigator's opinion, would compromise the patient's safety, ability to swallow, or outcome of the trial
- Pregnant or breastfeeding female patient
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 001
etravirine One etravirine (ETR) 200 mg uncoated oral tablet and one etravirine (ETR) 200 mg film-coated tablet
|
One etravirine (ETR) 200 mg uncoated oral tablet and one etravirine (ETR) 200 mg film-coated tablet
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Questionnaire using a 7-point scale to determine the acceptability of swallowing an uncoated 200 mg etravirine (ETR) tablet
Tidsramme: Assessment visit (Day 1)
|
Assessment visit (Day 1)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2010
Primær fullføring (Faktiske)
1. mai 2010
Studiet fullført (Faktiske)
1. mai 2010
Datoer for studieregistrering
Først innsendt
11. mars 2010
Først innsendt som oppfylte QC-kriteriene
18. mars 2010
Først lagt ut (Anslag)
22. mars 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. desember 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. desember 2012
Sist bekreftet
1. desember 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- HIV-infeksjoner
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Revers transkriptasehemmere
- Nukleinsyresyntesehemmere
- Enzymhemmere
- Etravirin
Andre studie-ID-numre
- CR017038
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på HIV-infeksjoner
-
Universidad del DesarrolloFullførtHealthcare Associated InfectionChile
-
Imelda Hospital, BonheidenFullførtHealthcare Associated InfectionBelgia
-
Centre Hospitalier Universitaire de NīmesRekrutteringEldre | Healthcare Associated InfectionFrankrike
-
Centre Hospitalier Universitaire, AmiensFullførtHealthcare Associated Infection | IglerFrankrike
-
Johns Hopkins UniversityFullførtHealthcare Associated Infection | Multiresistente organismer
-
University of PennsylvaniaFullførtAntimikrobiell resistensForente stater, Botswana
-
University of Maryland, BaltimoreVA Office of Research and DevelopmentFullførtMenneskelig mikrobiomForente stater
-
Universidad Autonoma de Nuevo LeonUkjentHelsetilknyttede infeksjoner
-
Children's Hospital Medical Center, CincinnatiAvsluttetAllogen hematopoetisk celletransplantasjonForente stater
-
University of Colorado, DenverUniversity of IowaFullførtHealth Care Associated Infection | HåndhygieneForente stater
Kliniske studier på etravirine
-
IRCCS Eugenio MedeaUniversity of Rome Tor VergataFullført
-
National Institute of Allergy and Infectious Diseases...FullførtHIV-infeksjonerForente stater, Brasil, Sør-Afrika
-
University of Colorado, DenverFullførtHepatitt C | HIVForente stater
-
Tibotec Pharmaceuticals, IrelandFullførtHIV-1Forente stater, Frankrike, Spania, Portugal, Canada, Storbritannia, Sør-Afrika, Argentina, Brasil, Puerto Rico, Thailand, Nederland, Romania
-
ViiV HealthcarePfizerTilbaketrukketHepatitt B | Hepatitt C, kronisk | Humant immunsviktvirusForente stater, Canada, Polen
-
Germans Trias i Pujol HospitalFullført
-
ANRS, Emerging Infectious DiseasesMerck Sharp & Dohme LLC; Janssen-Cilag Ltd.Fullført
-
Janssen R&D IrelandFullførtInfeksjon med humant immunsviktvirus (HIV).Frankrike, Ukraina, Forente stater, Mexico, Romania, Sør-Afrika, Peru, Argentina, Puerto Rico, Den russiske føderasjonen, Guatemala
-
University of North Carolina, Chapel HillJanssen PharmaceuticalsFullførtHIV-infeksjonerForente stater
-
Tibotec Pharmaceuticals, IrelandFullført