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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

Primary Purpose

HIV Infections, Hepatitis C

Status

Unknown status

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

LPV/r

PEG-IFNa 2a

Ribavirin

NUCS

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV/HCV, HIV and HCV coinfected patients, Treatment Experienced

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

San Raffaele Hospital, Dep. Infectious DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00437684

First Posted

February 20, 2007

Last Updated

February 5, 2009

Sponsor

IRCCS San Raffaele

Collaborators

Abbott, Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00437684

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

February 2007 (undefined)

Primary Completion Date

July 2010 (Anticipated)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

IRCCS San Raffaele

Collaborators

Abbott, Hoffmann-La Roche

4. Oversight

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Hepatitis C

Keywords

HIV/HCV, HIV and HCV coinfected patients, Treatment Experienced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

LPV/r

Intervention Description

200/50 mg 2 cpr bid monotherapy

Intervention Type

Drug

Intervention Name(s)

PEG-IFNa 2a

Intervention Description

PEG-IFNa 2a 180 mcg/week

Intervention Type

Drug

Intervention Name(s)

Ribavirin

Intervention Description

Ribavirin 1-1.2 g/day

Intervention Type

Drug

Intervention Name(s)

NUCS

Intervention Description

Nucleoside Reverse Transcriptase Inhibitors

Primary Outcome Measure Information:

Title

To assess if the combination of LPV/r monotherapy in association with anti-HCV

Time Frame

12 months

Title

Nucs) and PEG-IFN alfa 2a +Ribavirin in patients naïve for HCV treatment

Time Frame

12 months

Title

without previous failure or detection of any mutations related to PI resistance.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

To assess if LPV/r monotherapy during the HCV treatment is associated with

Time Frame

12 and 18 months

Title

anti HIV/HCV efficacy and a better patient satisfaction vs optimized HAART.

Time Frame

12 and 18 months

Title

To assess the number and type of HIV-1 resistance mutations in patients with

Time Frame

12 and 18 months

Title

virological failure

Time Frame

12 and 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Adriano Lazzarin, MD

Phone

+39/02/26437939

adriano.lazzarin@hsr.it

First Name & Middle Initial & Last Name or Official Title & Degree

Caterina Uberti-Foppa, MD

Phone

+39/02/26437938

caterina.uberti@hsr.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adriano Lazzarin, MD

Organizational Affiliation

IRCCS San Raffaele Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Raffaele Hospital, Dep. Infectious Diseases

City

Milan

ZIP/Postal Code

20127

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vega Rusconi

Phone

+39/02/26433646

vega.rusconi@hsr.it

First Name & Middle Initial & Last Name & Degree

Anna De Bona, MD

Phone

+39/02/26437932

anna.debona@hsr.it

First Name & Middle Initial & Last Name & Degree

Caterina Uberti-Foppa, MD

First Name & Middle Initial & Last Name & Degree

Adriano Lazzarin, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

23109014

Citation

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.

Results Reference

derived

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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

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