Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Antiretroviral (ARV) Naive Patients Starting Treatment With Anti-HCV Therapy

Last updated: February 5, 2009
Sponsor: IRCCS San Raffaele
Overall Status: Trial Status Unknown

Phase

3

Condition

Hiv Infections

Hepatitis

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT00437476
Kamon 1
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to evaluate if the combination of Lpv/r monotherapy and anti-HCV drugs does not match with additional toxicity induced by the association of HAART and Peg-IFN

  • ritonavir in patients naive for HIV and HCV.

Secondary objective is to assess if Lpv/r monotherapy during HCV-treatment is associated with HIV efficacy vs optimized HAART.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is >18 years old

  • Subject has given written informed consent

  • Serologic evidence of HIV infection by HIV antibody and HIV-RNA detection

  • Serologic evidence of HCV infection by HCV antibody and HCV-RNA detection

  • Subject is naive for HIV and HCV therapy

  • Subject has active chronic hepatitis or compensated cirrhosis (Child-Pugh class A)

  • Subject has a CD4+ count > 200 cell/mm3 and <500 cell/mm3.

  • Subject has genotype available at baseline and no mutations (IAS)associated withresistance to antiretroviral drugs used.

  • Subject and partner will use effective contraceptive methods for the duration of thestudy

Exclusion

Exclusion Criteria:

  • Subject is HbsAg positive

  • Subject has cirrhosis score Child-Pugh B/C, no previous hepatic decompensation

  • Subject has HIV-related thrombocytopenia (Platelets count < 50.000 mmc)

  • Subject has neutrophils count < 1500/mmc

  • Subject has Hb value < 9 g/dL at screening and <11 g/dL at randomization

  • Subject has creatinine value > 1.5 mg/dL

  • Subject is on a HAART regimen included ddI and/or AZT

  • Subject is pregnant or wishes to become so

  • Subject has any cause of liver disease other than chronic hepatitis C, status of liverdecompensation or any other condition consistent with decompensated liver disease (bleeding from esophageal varices, signs of current bleeding, significant ascites,hepatic encephalopathy)

  • Subject is alcohol abuser (> 30 gr/die)

  • Prior treatment with PEG-IFN/ribavirin

  • Illicit drugs abuse that in the opinion of the investigator could lead to poorcompliance with the terms of the protocol (maintenance treatment with methadoneallowed)

  • Active heart disease (e.g. angina, congestive heart failure, recent myocardialinfarction, or significant arrhythmia)

  • Subject has pre-existing severe depression, condition of severe psychiatric disorderssuch as suicidal ideation, suicide attempts, depression or acute psychosis

Study Design

Total Participants: 60
Study Start date:
February 01, 2007
Estimated Completion Date:
December 31, 2010

Study Description

This is a pilot, randomised, open label, controlled clinical trial. All eligible patients (CD4 count > 200 and no PI resistance)will receive 26 weeks induction HAART (LPV/r + selected NUCS). At the end of induction period (Phase I), all subjects with negative HIV-RNA from at least two months, Hb > 11 g/dL and CD4 count > 350 cells/mmc will be randomised (1:1), to receive LPV/r new tabs (200/50 mg, 2 cpr BID) monotherapy (arm A) or to continue the same HAART (arm B), associated to anti-HCV therapy for other 48 weeks (Phase II). The number of subjects to recruit will be 60 subjects to start the induction-phase with the aim to randomize, at least 25 subjects in each arm of the study. The total number of subjects to randomize will be 50. The Group A: will receive LPV/r + selected NRTIs for 26 weeks, followed by LPV/r monotherapy and anti HCV drugs for 48 weeks. Group B: will receive LPV/r+ selected NRTIs for 24 weeks, followed by the same HAART and anti-HCV drugs for 48 weeks. At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decision.All the patients will be followed-up for 24 weeks after the end of anti-HCV drugs for the evaluation of SVR.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day . At the end of week 12 of combined therapy, only patients who will reach an early virological response will continue anti-HCV drugs.

Connect with a study center

  • San Raffaele Hospital Dep. Infectious Diseases

    Milan, 20127
    Italy

    Active - Recruiting

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