Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Evaluation of the Pharmacokinetics of Antituberculosis Drugs and Tuberculosis Treatment Outcomes (SOUTH)

10. april 2015 opdateret af: Infectious Diseases Institute, Makerere University

Evaluation of the Pharmacokinetics of Antituberculosis Drugs and Tuberculosis Treatment Outcomes in HIV-tuberculosis Co-infected Ugandan Adults

Tuberculosis (TB) is a leading cause of death in HIV-infected individuals. There are insufficient data correlating concentrations of anti-TB drugs with treatment response. We hypothesize that sub-therapeutic concentrations of anti-TB drugs are associated with inadequate TB treatment response to Mycobacterium tuberculosis.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

During the study periodic monitoring will be conducted to ensure that the protocol and Good Clinical Practices (GCPs) are being followed.The monitors may review source documents to confirm that the data recorded on CRFs is accurate. The study site may be subject to review by the Institutional Review Board (IRB) and/or appropriate regulatory authorities.

A CRF will be completed for each included subject and will be signed by the investigator or by an authorized staff member to attest that the data is true. Any corrections to entries made in the CRFs, source documents must be dated, initialed and explained (if necessary) and should not obscure the original entry. Qualit assurance will as also be performed regularly on the CRFs.

The primary end point will be analyzed using Time to event (cure, death, relapse etc)analysis and failure rates and hazard ratios will be calculated accordig to categorical drug concentrations with proposed cutt offs.

Secondary end points will be analysed using time to event for occurence of toxicities which will also be corelated to the drug concentrations.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

400

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Uganda
      • Kampala, Uganda, 256
        • Rekruttering
        • Infectious Diseases Institute
        • Kontakt:
        • Ledende efterforsker:
          • Barbara Castelnuovo, MBChB, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Evidence of a personally signed and dated informed consent
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Age of ≥18 years
  • First episode of pulmonary TB i.e. proven or highly suspected TB considered for TB treatment qualifying for 6 months anti-Tb drugs regimen
  • Confirmed HIV-1 infection

Exclusion Criteria:

  • Unable to provide informed consent
  • Documented or highly suspected TB infection of any organs/systems other than the lung requiring TB treatment longer than 6 months
  • Previously treated for a mycobacterial infection (TB or atypical mycobacterial infection, active or latent)
  • Pregnancy or planned pregnancy within the next year
  • Unwillingness to perform pregnancy test
  • Decompensated liver disease and/or aminotransferases >5x ULN
  • GFR < 50 ml/min
  • Co-morbidities reducing life expectancy to <1 year (e.g. cancer)
  • Patient wishes to take part in another interventional study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: anti-tuberculosis drugs
Rifampicin, Isoniazid, Ethambutol, Pyrazinamide tablets 3 to 5 tablets once daily for 2 months followed by Rifampicin, Isoniazid 3 to 5 tablets once daily for 4 months
Medicin: Rifampicin, Isoniazid, Ethambutol, Pyrazinamide
Rifampicin, Isoniazid, Ethambutol, Pyrazinamide: 3, 4 or 5 tablets daily for weight below 55kg, above 55kg or above 70kg respectively for first 2 months followed by Rifampicin, Isoniazid: 3, 4 or 5 tablets daily for patients' weight below 55kg, above 55kg or above 70kg respectively for 4 months
Andre navne:
  • Forecox Trac
  • and Montozid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
clinical outcome
Tidsramme: At the end of treatment (6 months after enrolmet)
To investigate the association between serum concentrations of antituberculosis drugs and tuberculosis treatment response in HIV-TB-co-infected individuals.
At the end of treatment (6 months after enrolmet)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cmax
Tidsramme: At 2 weeks, 8 weeks and 24 weeks after anti-tuberculosis drug initiation
To investigate the steady-state pharmacokinetic parameters of anti-TB drugs at different time-points over the course of TB-treatment
At 2 weeks, 8 weeks and 24 weeks after anti-tuberculosis drug initiation
Number of adverse events
Tidsramme: 2 weeks, 8 weeks and 24 weeks after anti-tuberculosis drug initiation
To assess the safety and tolerability of anti-TB drugs based on the WHO guidelines
2 weeks, 8 weeks and 24 weeks after anti-tuberculosis drug initiation
ART trough levels
Tidsramme: At 2 weeks, 8 weeks and 24 weeks after anti-tuberculosis drug initiation
To correlate the effect of anti-TB drugs on plasma concentrations of efavirenz or protease inhibitors and vice versa.
At 2 weeks, 8 weeks and 24 weeks after anti-tuberculosis drug initiation
Isoniazid Cmax
Tidsramme: At 2 weeks, 8 weeks and 24 weeks
To evaluate the effect of acetylator geno-and phenotype (NAT-2 gene) on isoniazid plasma concentrations and toxicity
At 2 weeks, 8 weeks and 24 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Makerere University

Efterforskere

  • Ledende efterforsker: Barbara Castelnuovo, MD, PhD, Infectious Diseases Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2013

Primær færdiggørelse (Forventet)

1. marts 2016

Studieafslutning (Forventet)

1. marts 2016

Datoer for studieregistrering

Først indsendt

9. januar 2013

Først indsendt, der opfyldte QC-kriterier

1. februar 2013

Først opslået (Skøn)

4. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IDI

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 AIDS med tuberkulose

Kliniske forsøg med Rifampicin, Isoniazid, Ethambutol, Pyrazinamide

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Paraguay

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner