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Trial About Hepatic Security of Antiretroviral Treatment Based on Kaletra Versus Nevirapine in Co-infected HIV/HCV Patients

3 dicembre 2019 aggiornato da: Germans Trias i Pujol Hospital

Prospective, Open Label and Randomized Clinical Trial About Hepatic Security of Antiretroviral Treatment Based on Kaletra Versus Nevirapine in Co-infected HIV/HCV Patients

In retrospective studies, acceleration of hepatic fibrosis has been seen in Nevirapine (NVP) treatment when compared with Protease Inhibitors (PI) boosted with ritonavir treatment in patients with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) infection. The high incidence in our country of HIV-HCV co-infection, the availability of a new Kaletra (LPV/r) formulation (more convenient and better tolerated than soft capsules) as well as the possibility of analyzing hepatic fibrosis evolution in a fast and bloodless way, make attractive a study that, in a prospective way, could check the benefits of substituting NVP by LPV/r on hepatic fibrosis in this community.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The prevalence of the HIV-HCV co-infection in Spain is one of the highest because both infections are strongly related to parenteral drugs use; so, from 61 to 69 % of HIV infected patients are also HCV infected.

Acute HCV infection is asymptomatic in 60 to 70% of cases, being the chronification the natural illness evolution. 20% of the patients will develop hepatic cirrhosis after 20 to 30 years of being infected by the HCV. In cirrhosis cases, the hepatocellular carcinoma appears in a rate of 2 to 4% per year, according to studies done with HCV mono-infected patients. Fibrosis progression depends basically on the duration of HCV infection and on the age of infection, but also on other factors, like gender (is faster in men), alcohol consumption (worst over 50 g per day) and HIV co-infection. Several epidemiologist studies have described the negative impact of HIV co-infection, accelerating the progression to cirrhosis and the hepatocarcinoma.

The Highly Active Antiretroviral Treatment (HAART) has a positive impact on survival on co-infected patients, although the three drug families used in HAART can cause hepatic toxicity in this group of patients. Hepatic toxicity appears in 5 to 20% of patients, being more serious and common, but not exclusive, in case of NVP treatment.

On their part, not all PI have the same hepatotoxic profile. An association between serious hepatotoxicity and ritonavir at full strength, indinavir and indinavir plus saquinavir boosted with ritonavir has been found.

As far as fibrosis is concerned, there are studies that show that in HIV/HCV co-infected patients PI-based regimens are associated with a lower progression to fibrosis, while the progression rate to cirrhosis is higher in NVP-based regimens, mainly in those patients with advanced hepatic fibrosis.

Hepatic biopsy is considered the reference test to assess hepatic fibrosis, nevertheless it is an invasive, painful and with a low but potentially serious risk for the patient's life. Moreover, the viability of a hepatic biopsy can be doubted due to sampling error or interobservation variability. For that reason, several biochemist tests have been developed to reflect the hepatic fibrosis extent or stage in a reliable way. Recently a hepatic rigidity measure through elastography has been presented as a non-invasive and very promising method to assess hepatic fibrosis.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

9

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Spagna
      • Alicante, Spagna, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spagna, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Madrid, Spagna, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spagna, 28046
        • Hospital Universitario La Paz
      • Madrid, Spagna, 28005
        • Hospital Universitario Príncipe de Asturias
      • Salamanca, Spagna, 37007
        • Hospital Clínico de Salamanca
      • Sevilla, Spagna, 41014
        • Hospital Universitario de Valme
    • Baleares
      • Palma de Mallorca, Baleares, Spagna, 07014
        • Hospital Son Dureta
    • Barcelona
      • Badalona, Barcelona, Spagna, 08916
        • H.U. Germans Trias i Pujol - Unitat VIH, Fundació Lluita contra la Sida

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 60 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. 18 years old or elder.
  2. HCV and HIV co-infected patients.
  3. Patients with antiretroviral treatment based in NVP plus 2 NRTIs (or 1 NRTI and Tenofovir), with undetectable viral load (under 50 copies/mL) during at least the last 24 weeks.
  4. If women and of childbearing age, negative pregnancy test. Furthermore, barrier contraceptive method must be undertaken during the study.
  5. Date and signature of the informed consent.

Exclusion Criteria:

  1. Concomitant treatment with drugs that can significantly interact with the study drugs.
  2. Opportunistic infections in the last 6 months.
  3. Patients who can be candidates for an HCV infection treatment in the next 3 years.
  4. Patients in who efficacy of previous NRTIs can not be ensured. For example, patients with mono or dual therapy history or with previous blips in whom NRTI-related mutations were identified that could reduce the sensibility to the used backbone.
  5. Active alcohol consumption (over 50 g per day) or other substance abuse.
  6. Pregnant or breastfeeding women.
  7. Patients with transaminase level over 5 times the Upper Limit of Normality (ULN) or Creatinin over 2 mg/dL or Total Bilirubin over 3 times the ULN.
  8. Any formal contraindication for being treated with the study drugs.
  9. Patients who, basing in their antiretroviral treatment history, could be considered as being infected with a virus that has no sensibility to LPV.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 1
Nevirapine
Droga: Nevirapine
2 ITIAN (o 1 ITIAN+TDF)+ nevirapine, 2 tablet 200/50 mg to 12 hours
Sperimentale: 2
Lopinavir/ritonavir
Droga: Lopinavir/ritonavir
2 ITIAN (o 1 ITIAN+TDF)+ lopinavir/ritonavir, 2 tablet 200/50 mg to 12 hours

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
The average of hepatic rigidity increase in each group. Hepatic rigidity will be measured in kilopascals through elastography (Fibroscan). Distribution of hepatic rigidity will be normalized by a logarithmic transformat
Lasso di tempo: From Basal to 144 week (last visit) every 3 months
From Basal to 144 week (last visit) every 3 months

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Virological and immunologic efficacy will be assessed through the proportion of patients with virological failure during the follow-up and the CD4 lymphocytes count of both treatment regimens.
Lasso di tempo: From Basal to 144 week (last visit) every 3 months
From Basal to 144 week (last visit) every 3 months
The effect of both treatments in lipidic and glucidic metabolism will be assessed through the following variables: Total Cholesterol, HDL and LDL Cholesterol, Triglycerides and Glucose.
Lasso di tempo: From Basal to 144 week (last visit) every 3 months
From Basal to 144 week (last visit) every 3 months
Higher than log 7.2 Kpa in patients with non-significant basal fibrosis (less than log 7.2 Kpa)
Lasso di tempo: From Basal to 144 week (last visit) every 3 months
From Basal to 144 week (last visit) every 3 months
The security of each regimen will be studied through the proportion of patients who give up treatment because of adverse events and hepatic-related adverse events presence.
Lasso di tempo: From Basal to 144 week (last visit) every 3 months
From Basal to 144 week (last visit) every 3 months
Toxicity will be determined depending on: Clinical History and Physical Examination; Coagulation, hemogram and chemistry tests, which will include: transaminase levels, GGT, alkaline phosphatase, bilirrubin, albumin, urea and creatinin
Lasso di tempo: From Basal to 144 week (last visit) every 3 months
From Basal to 144 week (last visit) every 3 months
Mortality rate during the study will be evaluated.
Lasso di tempo: From Basal to 144 week (last visit) every 3 months
From Basal to 144 week (last visit) every 3 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Germans Trias i Pujol Hospital

Collaboratori

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2008

Completamento primario (Effettivo)

1 dicembre 2008

Completamento dello studio (Effettivo)

1 dicembre 2008

Date di iscrizione allo studio

Primo inviato

10 aprile 2008

Primo inviato che soddisfa i criteri di controllo qualità

15 aprile 2008

Primo Inserito (Stima)

18 aprile 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 dicembre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 dicembre 2019

Ultimo verificato

1 dicembre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A10-174 (KANELA)

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 .

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