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

Primary Purpose

HIV Infections, Hepatitis C

Status

Unknown status

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

LPV/r

Nucleoside Reverse Transcriptase Inhibitors

PEG-IFNa 2a

Ribavirin

About this trial

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

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
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 with resistance to antiretroviral drugs used.
Subject and partner 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 < 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 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)
Prior treatment with PEG-IFN/ribavirin
Illicit drugs abuse that in the opinion of the investigator could lead to poor compliance with the terms of the protocol (maintenance treatment with methadone 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

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 + selected NRTIs for 26 weeks, followed by LPV/r monotherapy and anti HCV drugs for 48 weeks. 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.

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.

Outcomes

Primary Outcome Measures

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

anti-HCV therapy (PEG IFN alfa 2a + Ribavirin) does not match with additional

toxicity induced by the combination of optimized HAART (Lopinavir/ritonavir + selected Nucs) and PEG-IFN alfa 2a+Ribavirin

in patients naïve for HIV and HCV

Secondary Outcome Measures

To assess if LPV/r monotherapy during the HCV treatment

is associated with anti HIV efficacy and a better patient satisfaction

vs optimized HAART.

Full Information

NCT ID

NCT00437476

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

NCT00437476

Brief Title

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

Official Title

Pilot, Multicenter, Randomized Study on Lopinavir/Ritonavir-Monotherapy vs Lopinavir/Ritonavir Plus Selected Nucs, in HIV/HCV ARV-Naive 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 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.

Detailed 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.

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 Naive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (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

Lopinavir/Ritonavir 200/50 mg 2 cpr BID monotherapy - 26 weeks (A) or 24 weeks (B)

Intervention Type

Drug

Intervention Name(s)

Nucleoside Reverse Transcriptase Inhibitors

Intervention Description

NRTIs for 26 weeks (A) or 24 weeks (B)

Intervention Type

Drug

Intervention Name(s)

PEG-IFNa 2a

Intervention Description

PEG-IFNa 2a 180 mcg/week (48 weeks)

Intervention Type

Drug

Intervention Name(s)

Ribavirin

Intervention Description

Ribavirin 1-1.2 g/day (48 weeks)

Primary Outcome Measure Information:

Title

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

Time Frame

18 months

Title

anti-HCV therapy (PEG IFN alfa 2a + Ribavirin) does not match with additional

Time Frame

18 months

Title

toxicity induced by the combination of optimized HAART (Lopinavir/ritonavir + selected Nucs) and PEG-IFN alfa 2a+Ribavirin

Time Frame

18 months

Title

in patients naïve for HIV and HCV

Time Frame

18 months

Secondary Outcome Measure Information:

Title

To assess if LPV/r monotherapy during the HCV treatment

Time Frame

18 and 24 months

Title

is associated with anti HIV efficacy and a better patient satisfaction

Time Frame

18 and 24 months

Title

vs optimized HAART.

Time Frame

18 and 24 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 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 with resistance to antiretroviral drugs used. Subject and partner 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 < 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 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) Prior treatment with PEG-IFN/ribavirin Illicit drugs abuse that in the opinion of the investigator could lead to poor compliance with the terms of the protocol (maintenance treatment with methadone 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

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

Giulia Gallotta, MD

Phone

+39/02/26437938

giulia.gallotta@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

Learn more about this trial

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

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