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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by IRCCS San Raffaele.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Abbott
Hoffmann-La Roche
Information provided by:
IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT00437684
First received: February 20, 2007
Last updated: February 5, 2009
Last verified: February 2009

February 20, 2007
February 5, 2009
February 2007
July 2010   (final data collection date for primary outcome measure)
  • To assess if the combination of LPV/r monotherapy in association with anti-HCV [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Nucs) and PEG-IFN alfa 2a +Ribavirin in patients naïve for HCV treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • without previous failure or detection of any mutations related to PI resistance. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To assess if the combination of LPV/r monotherapy in association with anti-HCV
  • Nucs) and PEG-IFN alfa 2a +Ribavirin in patients naïve for HCV treatment
  • without previous failure or detection of any mutations related to PI resistance.
  • therapy (PEG IFN alfa 2a + Ribavirin) does not match with additional toxicity
  • induced by the combination of optimized HAART (Lopinavir/ritonavir + selected
Complete list of historical versions of study NCT00437684 on ClinicalTrials.gov Archive Site
  • To assess if LPV/r monotherapy during the HCV treatment is associated with [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]
  • anti HIV/HCV efficacy and a better patient satisfaction vs optimized HAART. [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]
  • To assess the number and type of HIV-1 resistance mutations in patients with [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]
  • virological failure [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]
  • To assess if LPV/r monotherapy during the HCV treatment is associated with
  • anti HIV/HCV efficacy and a better patient satisfaction vs optimized HAART.
  • To assess the number and type of HIV-1 resistance mutations in patients with
  • virological failure
Not Provided
Not Provided
 
Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Patients Starting Treatment With Anti-Hepatitis C Virus (HCV) Therapy
A Pilot, Open Label, Multicenter, Randomized Clinical Trial on Lopinavir/Ritonavir-Monotherapy vs Lopinavir/Ritonavir Plus Selected Nucs, in HIV/HCV Coinfected Patients With Chronic Hepatitis C or Compensated Cirrhosis, Starting Treatment With Ribavirin and Pegylated Interferon

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 HIV/HCV coinfected patients.

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

This is a pilot, randomised, open label, controlled clinical trial. All eligible patients(CD4>350, HIV RNA<50 copies and no PI mutations) will be randomized (1:1) to receive LPV/r new tabs (200/50 mg, 2 cpr BID) monotherapy (arm A) or LPV/r + selected NUCS (arm B) associated to anti-HCV therapy for 12 months. The number of subjects to recruit, in each arm of the study, is equal to 25, the total number of subjects to enrol will be 50.

  • Group A: will receive LPV/r monotherapy and anti HCV drugs for 12 months.
  • Group B: will receive LPV/r+ selected NUCS and anti HCV drugs for 12 months. All the patients will be followed-up for six months after the end of anti-HCV drugs for the evaluation of Sustained Virological Response (SVR). At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decisions.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day .At the end of the third month of combined therapy, only patients who reach an early virological response will continue anti-HCV drugs.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Hepatitis C
  • Drug: LPV/r
    200/50 mg 2 cpr bid monotherapy
  • Drug: PEG-IFNa 2a
    PEG-IFNa 2a 180 mcg/week
  • Drug: Ribavirin
    Ribavirin 1-1.2 g/day
  • Drug: NUCS
    Nucleoside Reverse Transcriptase Inhibitors
  • Experimental: A
    LPV/r: LPV/r monotherapy and anti HCV drugs for 12 months. All the patients will be followed-up for six months after the end of anti-HCV drugs for the evaluation of Sustained Virological Response (SVR). At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decisions.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day .At the end of the third month of combined therapy, only patients who reach an early virological response will continue anti-HCV drugs.
    Interventions:
    • Drug: LPV/r
    • Drug: PEG-IFNa 2a
    • Drug: Ribavirin
  • Active Comparator: B
    LPV/r+ selected NUCS and anti HCV drugs for 12 months. All the patients will be followed-up for six months after the end of anti-HCV drugs for the evaluation of Sustained Virological Response (SVR). At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decisions.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day .At the end of the third month of combined therapy, only patients who reach an early virological response will continue anti-HCV drugs.
    Interventions:
    • Drug: LPV/r
    • Drug: PEG-IFNa 2a
    • Drug: Ribavirin
    • Drug: NUCS
Hasson H, Galli L, Gallotta G, Neri V, Blanc P, D'Annunzio M, Morsica G, Sollima S, Merli M, Lazzarin A, Uberti-Foppa C. HAART simplification with lopinavir/ritonavir monotherapy in HIV/HCV co-infected patients starting anti-HCV treatment: a randomised pilot study (KaMon study). New Microbiol. 2012 Oct;35(4):469-74. Epub 2012 Oct 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is >18 years old
  • Subject has given written informed consent
  • Subject has a confirmed diagnosis of HIV and HCV infection
  • Subject is naive for HCV-infection treatment
  • Subject has chronic hepatitis and/or subject has compensated cirrhosis (Child class A)
  • Subject has a CD4+ count of > 350 cell/mmc
  • Subject is HIV-RNA negative during the previous six month
  • Subject is on stable HAART including r/LPV for > 6 months
  • Subject has genotype available at baseline and no mutations associated with resistance to PI or no virologic failure on PI treatment, defined as a confirmed HIV-RNA level>50 cp/mL after 24 weeks, > 50 cp/ml after 48 weeks, or a repeated HIV RNA level > 50 cp/mL after prior suppression of viremia to< 50 cps/mL.
  • Free of any clinically significant disease (other than HIV and HCV) that would interfere with study evaluations.
  • Subject will use effective contraceptive methods for the duration of the study

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 < 11 g/dL
  • Subject has creatinine value > 1.5 mg/dL
  • Subject is pregnant or wishes to become so
  • Subject has any cause of liver disease other than chronic hepatitis C, status of liver decompensation 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)
  • Subject has autoimmune hepatitis
  • Prior treatment with PEG-IFN or ribavirin
  • Illicit drugs abuse that in the opinion of the investigator could lead to poor compliance with the terms of the protocol (Methadone sostitution therapy allowed)
  • Active heart disease (e.g. angina, congestive heart failure, recent myocardial infarction or significant arrhythmia)
  • Subject has pre-existing severe depression, condition of severe psychiatric disorders such as suicidal ideation, suicide attempts, depression or acute psychosis
  • Subject has uncompensated diabetes
  • Subject has active opportunistic infections or major opportunistic infections during the previous 12 months
  • Subject has known hypersensitivity or contraindication to study medications
  • Subject has any other condition that in the opinion of the investigator will make the subject unsuitable for enrolment or will interfere with the subject participating in or completing the study
Both
18 Years to 65 Years
No
Contact: Adriano Lazzarin, MD +39/02/26437939 adriano.lazzarin@hsr.it
Contact: Caterina Uberti-Foppa, MD +39/02/26437938 caterina.uberti@hsr.it
Italy
 
NCT00437684
Kamon 2, NTC00437684
Not Provided
Adriano Lazzarin, IRCCS San Raffaele
IRCCS San Raffaele
  • Abbott
  • Hoffmann-La Roche
Principal Investigator: Adriano Lazzarin, MD IRCCS San Raffaele Hospital
IRCCS San Raffaele
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP