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

NCT00437476

First received: February 20, 2007

Last updated: February 5, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 20, 2007

Last Updated Date

February 5, 2009

Start Date ^ICMJE

February 2007

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To assess if the combination of LPV/r monotherapy in association with [ Time Frame: 18 months ] [ Designated as safety issue: No ]
anti-HCV therapy (PEG IFN alfa 2a + Ribavirin) does not match with additional [ Time Frame: 18 months ] [ Designated as safety issue: No ]
toxicity induced by the combination of optimized HAART (Lopinavir/ritonavir + selected Nucs) and PEG-IFN alfa 2a+Ribavirin [ Time Frame: 18 months ] [ Designated as safety issue: No ]
in patients naïve for HIV and HCV [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00437476 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess if LPV/r monotherapy during the HCV treatment [ Time Frame: 18 and 24 months ] [ Designated as safety issue: No ]
is associated with anti HIV efficacy and a better patient satisfaction [ Time Frame: 18 and 24 months ] [ Designated as safety issue: No ]
vs optimized HAART. [ Time Frame: 18 and 24 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To assess if LPV/r monotherapy during the HCV treatment
is associated with anti HIV efficacy and a better patient satisfaction
vs optimized HAART.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections
Hepatitis C

Intervention ^ICMJE

Drug: LPV/r
Lopinavir/Ritonavir 200/50 mg 2 cpr BID monotherapy - 26 weeks (A) or 24 weeks (B)
Drug: Nucleoside Reverse Transcriptase Inhibitors
NRTIs for 26 weeks (A) or 24 weeks (B)
Drug: PEG-IFNa 2a
PEG-IFNa 2a 180 mcg/week (48 weeks)
Drug: Ribavirin
Ribavirin 1-1.2 g/day (48 weeks)

Study Arm (s)

Experimental: A
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.
Interventions:
- Drug: LPV/r
- Drug: Nucleoside Reverse Transcriptase Inhibitors
- Drug: PEG-IFNa 2a
- Drug: Ribavirin
Active Comparator: B
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.
Interventions:
- Drug: LPV/r
- Drug: Nucleoside Reverse Transcriptase Inhibitors
- Drug: PEG-IFNa 2a
- Drug: Ribavirin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Adriano Lazzarin, MD	+39/02/26437939	adriano.lazzarin@hsr.it
Contact: Caterina Uberti-Foppa, MD	+39/02/26437938	caterina.uberti@hsr.it

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00437476

Other Study ID Numbers ^ICMJE

Kamon 1

Has Data Monitoring Committee

Not Provided

Responsible Party

adriano lazzarin, IRCCS San Raffaele

Study Sponsor ^ICMJE

IRCCS San Raffaele

Collaborators ^ICMJE

Abbott
Hoffmann-La Roche

Investigators ^ICMJE

Principal Investigator:

Adriano Lazzarin, MD

IRCCS San Raffaele Hospital

Information Provided By

IRCCS San Raffaele

Verification Date

February 2009

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

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