Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Patients Starting Treatment With Anti-Hepatitis C Virus (HCV) Therapy
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
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hiv-infections
Started Feb 2007
Typical duration for phase_3 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 20, 2007
CompletedFirst Posted
Study publicly available on registry
February 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 6, 2009
February 1, 2009
3.4 years
February 20, 2007
February 5, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
To assess if the combination of LPV/r monotherapy in association with anti-HCV
12 months
Nucs) and PEG-IFN alfa 2a +Ribavirin in patients naïve for HCV treatment
12 months
without previous failure or detection of any mutations related to PI resistance.
12 months
Secondary Outcomes (4)
To assess if LPV/r monotherapy during the HCV treatment is associated with
12 and 18 months
anti HIV/HCV efficacy and a better patient satisfaction vs optimized HAART.
12 and 18 months
To assess the number and type of HIV-1 resistance mutations in patients with
12 and 18 months
virological failure
12 and 18 months
Study Arms (2)
A
EXPERIMENTALLPV/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.
B
ACTIVE COMPARATORLPV/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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IRCCS San Raffaelelead
- Abbottcollaborator
- Hoffmann-La Rochecollaborator
Study Sites (1)
San Raffaele Hospital, Dep. Infectious Diseases
Milan, 20127, Italy
Related Publications (1)
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.
PMID: 23109014DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adriano Lazzarin, MD
IRCCS San Raffaele Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 20, 2007
First Posted
February 21, 2007
Study Start
February 1, 2007
Primary Completion
July 1, 2010
Study Completion
December 1, 2010
Last Updated
February 6, 2009
Record last verified: 2009-02