Clinical Trial: Treatment of HIV/HCV Coinfection With Peg-IFN and Ribavirin in Patients Receiving ART Monotherapy With Lopinavir/r

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Randomized, Open Label, Pilot Study to Assess the Possibility of Concomitant Treatment of HCV/HIV co Infection With Peg-interferon + Ribavirin, and Lopinavi

Brief Summary: The aim of this study is to assess the efficacy of lopinavir/r in monotherapy and peg-interferon plus ribavirin for the control of both HIV and HCV infection respectively after 12 months of active treatment for HCV.

Detailed Summary:

Viral hepatitis, mainly when caused by the hepatitis C virus (HCV), is highly significant in the setting of infection by the human immunodeficiency virus (HIV) because high activity antiretroviral therapy (HAART) has a very favorable impact upon morbidity and mortality of this disease. HAART has achieved disease control, significantly increasing survival and improving the quality of life of subjects with HIV infection.

Spain has one of the highest prevalences of HIV-HCV co-infection because both HCV and HIV infection are strongly associated to being or having been an intravenous drug user (IDU); thus, from 61% to 69% of these subjects infected by HIV in Spain are also infected by HCV.

From 1998, standard treatment for chronic C hepatitis consists of the combination of interferon alpha and ribavirin, based on an increased efficacy versus interferon monotherapy; however, development of pegylated interferon, with a more convenient bioavailability as compared to conventional interferon alpha, has allowed for developing even more effective combined therapies and the possibility of improving response prediction based on changes in viremia within the first few weeks of treatment. However, treatment of HCV infection usually involves severe side effects, which often lead to treatment discontinuation or to the need for adjusting drug dosage, in which case treatment efficacy may decrease.

HCV+ subjects who, because of HIV co-infection, should also receive HAART, may have an increased number or increased severity of adverse reactions due to interactions occurring with drug co-administration.

Lopinavir/ritonavir (LPV/r) is a potent HIV protease inhibitor and is characterized by a very high pharmacological and genetic barrier.

Sponsor: Fundacion SEIMC-GESIDA

Current Primary Outcome: Assess efficacy of concomitant treatment with lopinavir/r monotherapy and PEG-INF plus RBV for the control of both HIV and HCV infection respectively after 12 months of active treatment for HCV [ Time Frame: 80 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tolerability and safety of concomitant treatment with LPV/r, PEG-INF and RBV [ Time Frame: 80 weeks ]
  • CD4 [ Time Frame: 80 weeks ]
  • Efficacy [ Time Frame: 80 weeks ]
  • Adherence [ Time Frame: 80 weeks ]


Original Secondary Outcome: Same as current

Information By: Fundacion SEIMC-GESIDA

Dates:
Date Received: March 18, 2009
Date Started: February 2008
Date Completion:
Last Updated: March 21, 2013
Last Verified: March 2013