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

NCT ID: NCT00437684

Last Updated: 2009-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2010-12-31

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.

Conditions

HIV Infections; Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

LPV/r

Intervention Type: DRUG

200/50 mg 2 cpr bid monotherapy

PEG-IFNa 2a

Intervention Type: DRUG

PEG-IFNa 2a 180 mcg/week

Ribavirin

Intervention Type: DRUG

Ribavirin 1-1.2 g/day

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.

Group Type: ACTIVE_COMPARATOR

LPV/r

Intervention Type: DRUG

200/50 mg 2 cpr bid monotherapy

PEG-IFNa 2a

Intervention Type: DRUG

PEG-IFNa 2a 180 mcg/week

Ribavirin

Intervention Type: DRUG

Ribavirin 1-1.2 g/day

NUCS

Intervention Type: DRUG

Nucleoside Reverse Transcriptase Inhibitors

Interventions

LPV/r

200/50 mg 2 cpr bid monotherapy

Intervention Type: DRUG

PEG-IFNa 2a

PEG-IFNa 2a 180 mcg/week

Intervention Type: DRUG

Ribavirin

Ribavirin 1-1.2 g/day

Intervention Type: DRUG

NUCS

Nucleoside Reverse Transcriptase Inhibitors

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

IRCCS San Raffaele

Principal Investigators

Adriano Lazzarin, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele Hospital

Locations

San Raffaele Hospital, Dep. Infectious Diseases

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Adriano Lazzarin, MD

Role: CONTACT

adriano.lazzarin@hsr.it

+39/02/26437939

Caterina Uberti-Foppa, MD

Role: CONTACT

caterina.uberti@hsr.it

+39/02/26437938

Facility Contacts

Vega Rusconi

Role: primary

vega.rusconi@hsr.it

+39/02/26433646

Anna De Bona, MD

Role: backup

anna.debona@hsr.it

+39/02/26437932

References

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.

Reference Type: DERIVED

PMID: 23109014 (View on PubMed)

Other Identifiers

NTC00437684

Identifier Type: -

Identifier Source: secondary_id

Kamon 2

Identifier Type: -

Identifier Source: org_study_id