- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02628691
Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia (HCV-Monitoring)
Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia (HCV-Monitoring)
Data on the progression of liver fibrosis in patients co-infected with HIV taking effective suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier (than F3-F4) treatment in co-infected patients.
Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the opportunity to monitor for short-term fibrosis progression in a cohort of co-infected patients with initial no-to-moderate fibrosis being identified during another ongoing study (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2.
The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2, -3 or -6 but are not considered in immediate need of HCV treatment.
All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk hospital Center of Hope who are identified during the HCV-Epi study having chronic HCV infection (all genotypes) and considered not in immediate need of HCV treatment (= Fibrosis stages F0-F2 and no clinical signs of extra-hepatic disease) will be considered for inclusion and invited to participate.
Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be enrolled in this study.
Beyond the baseline visit (HCV-Epi), follow-up visits are planned at 6, 12, 18 and 24 months. These patient visits will comprise of a history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters. Additionally, patients will be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.
Panoramica dello studio
Descrizione dettagliata
Data on the progression of liver fibrosis in patients co-infected with HIV taking effective suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier (than F3-F4) treatment in co-infected patients.
Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the opportunity to monitor for short-term fibrosis progression in a cohort of co-infected patients with initial no-to-moderate fibrosis being identified during another ongoing study (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2.
The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2, -3 or -6 but are not considered in immediate need of HCV treatment.
The study will be conducted in Sihanouk Hospital Center of Hope (SHCH) in Phnom Penh (Cambodia), more particularly within the ambulatory HIV clinic setting. SHCH is a non-governmental hospital providing comprehensive HIV care free of charge since March 2003, as part of the national antiretroviral (ARV) program. They dispose of an experienced HIV clinician, counselor and social worker team and several operational research studies were conducted within this setting.
All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk hospital Center of Hope who are identified during the HCV-Epi study having chronic HCV infection (all genotypes) and considered not in immediate need of HCV treatment (= Fibrosis stages F0-F2 and no clinical signs of extra-hepatic disease) will be considered for inclusion and invited to participate.
Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be enrolled in this study. No formal sample size is being calculated. The final sample will comprise all patients fulfilling the inclusion criteria.
The data collected from the HCV-Epi study will be considered as the baseline visit for the HCV-Monitoring study. Thereafter, visits are planned at 6, 12, 18 and 24 months follow-up. These patient visits will, beyond the habitual HIV follow-up, integrate a history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters. Additionally, patients will be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
-
-
-
Phnom Penh, Cambogia
- Sihanouk Hospital Center of HOPE (SHCH), Cambodia
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Male and females
- ≥18 years
- Documented HIV infection
- Evidence of infection with hepatitis C virus (all genotypes): Positive anti-HCV antibody and HCV RNA
Absence of advanced liver disease or clinical signs of extra-hepatic disease:
- F0-F2 (< 9,5 kPa) established by transient elastography, and
- No clinical signs of extra-hepatic disease
- Not on HCV antiviral treatment
Exclusion Criteria:
- Currently on/or history of hepatitis C treatment
- Patients with initial fibrosis stage ≥ F3 (≥ 9,5 kPA on transient elastography)
- Patients not able/willing to adhere to the consultation, laboratory and liver stiffness measurement testing schedule as proposed in this study
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
HCV coinfection with no-to-moderate fibrosis
|
A history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters will be performed.
Patients will also be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Short-term progression to advanced liver fibrosis
Lasso di tempo: 30 months
|
Proportion of patients who progress to advanced liver fibrosis (F≥3; LSM ≥9.5 kPa).
|
30 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Demographic characteristics
Lasso di tempo: Baseline
|
Demographic baseline characteristics of the study participants
|
Baseline
|
Clinical characteristics
Lasso di tempo: Baseline
|
Clinical baseline characteristics of the study participants
|
Baseline
|
Laboratory characteristics
Lasso di tempo: Baseline
|
Laboratory baseline characteristics of the study participants
|
Baseline
|
Progression to cirrhosis
Lasso di tempo: 30 months
|
Proportion of patients who progress to cirrhosis ((F=4, > 14 kPa)
|
30 months
|
Liver stiffness measurement
Lasso di tempo: 30 months
|
Median Liver stiffness measurement increase per year
|
30 months
|
Changes in fibrosis stage scores
Lasso di tempo: 30 months
|
Change in Metavir score (regression/progression, number of stages difference)
|
30 months
|
Diagnostic accuracy of non-invasive serum bio-markers: APRI
Lasso di tempo: 30 months
|
Predictive value of APRI to identify a shift from (≤F2) to advanced fibrosis (≥3)
|
30 months
|
Diagnostic accuracy of non-invasive serum bio-markers: FIB-4
Lasso di tempo: 30 months
|
Predictive value of FIB-4 to identify a shift from (≤F2) to advanced fibrosis (≥3)
|
30 months
|
Predictive factors for liver fibrosis progression
Lasso di tempo: 30 months
|
Factors associated with rapid fibrosis progression in HCV/HIV coinfected patients with initial mild to moderate fibrosis: age, gender, alcohol use, smoking, coffee consumption, comorbidities, liver enzymes, HCV viral load, HIV viral load, and ART exposure
|
30 months
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Anja De Weggheleire, MD, Institute of Tropical Medicine, Antwerp, Belgium
- Investigatore principale: An Sokkab, MD, Sihanouk Hospital Center of HOPE (SHCH), Cambodia
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Processi patologici
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Attributi della malattia
- Flaviviridae Infezioni
- Epatite, virale, umana
- Infezioni da enterovirus
- Infezioni da Picornaviridae
- Malattie del fegato
- Progressione della malattia
- Epatite
- Epatite A
- Epatite C
Altri numeri di identificazione dello studio
- HCV-Monitoring
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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 .
Prove cliniche su Liver fibrosis progression
-
Johns Hopkins UniversityAttivo, non reclutanteMalattia epatica allo stadio terminaleStati Uniti
-
Northwestern UniversityReclutamentoFragilità | Cirrosi | Trapianto di fegatoStati Uniti
-
The University of Texas Health Science Center,...Prevent Cancer FoundationCompletatoMalattia del fegato grasso non alcolicaStati Uniti
-
Radboud University Medical CenterPhilips Electronics Nederland B.V. acting through Philips CTO organization; Michael... e altri collaboratoriCompletatoMorbo di ParkinsonOlanda
-
Academisch Medisch Centrum - Universiteit van Amsterdam...PerspectumNon ancora reclutamento