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

February 5, 2009 updated by: IRCCS San Raffaele

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20127
        • Recruiting
        • San Raffaele Hospital, Dep. Infectious Diseases
        • Contact:
        • Sub-Investigator:
          • Caterina Uberti-Foppa, MD
        • Principal Investigator:
          • Adriano Lazzarin, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess if the combination of LPV/r monotherapy in association with anti-HCV
Time Frame: 12 months
12 months
Nucs) and PEG-IFN alfa 2a +Ribavirin in patients naïve for HCV treatment
Time Frame: 12 months
12 months
without previous failure or detection of any mutations related to PI resistance.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess if LPV/r monotherapy during the HCV treatment is associated with
Time Frame: 12 and 18 months
12 and 18 months
anti HIV/HCV efficacy and a better patient satisfaction vs optimized HAART.
Time Frame: 12 and 18 months
12 and 18 months
To assess the number and type of HIV-1 resistance mutations in patients with
Time Frame: 12 and 18 months
12 and 18 months
virological failure
Time Frame: 12 and 18 months
12 and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Collaborators

Hoffmann-La Roche
Abbott

Investigators

  • Principal Investigator: Adriano Lazzarin, MD, IRCCS San Raffaele Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Anticipated)

July 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

February 20, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (Estimate)

February 21, 2007

Study Record Updates

Last Update Posted (Estimate)

February 6, 2009

Last Update Submitted That Met QC Criteria

February 5, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kamon 2
  • NTC00437684

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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