skip to content

Clinical Trials

MainTitle

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.

Verified February 2009

Sponsor
IRCCS San Raffaele

Collaborator
Abbott
Hoffmann-La Roche

Information provided by (Responsible Party)
IRCCS San Raffaele
ClinicalTrials.gov Identifier
NCT00437476

First received: February 20, 2007
Last updated: February 5, 2009
Last Verified: February 2009
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections
Hepatitis C

Drug : LPV/r
Drug : Nucleoside Reverse Transcriptase Inhibitors
Drug : PEG-IFNa 2a
Drug : Ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures

  • To assess if the combination of LPV/r monotherapy in association with [ Time Frame: 18 months ]
  • anti-HCV therapy (PEG IFN alfa 2a + Ribavirin) does not match with additional [ Time Frame: 18 months ]
  • toxicity induced by the combination of optimized HAART (Lopinavir/ritonavir + selected Nucs) and PEG-IFN alfa 2a+Ribavirin [ Time Frame: 18 months ]
  • in patients naïve for HIV and HCV [ Time Frame: 18 months ]
Secondary Outcome Measures:
  • To assess if LPV/r monotherapy during the HCV treatment [ Time Frame: 18 and 24 months ]
  • is associated with anti HIV efficacy and a better patient satisfaction [ Time Frame: 18 and 24 months ]
  • vs optimized HAART. [ Time Frame: 18 and 24 months ]

Estimated Enrollment: 60
Study Start Date: February 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.
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)

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.
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)

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437476

Contacts

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

Locations

Italy
San Raffaele Hospital Dep. Infectious Diseases Recruiting
Milan, Italy, 20127
Contact: Vega Rusconi    +39/02/26433646    vega.rusconi@hsr.it
Contact: Giulia Gallotta, MD    +39/02/26437938    giulia.gallotta@hsr.it
Sub-Investigator: Caterina Uberti-Foppa, MD
Principal Investigator: Adriano Lazzarin, MD

Sponsors and Collaborators

IRCCS San Raffaele
Abbott
Hoffmann-La Roche

Investigators

Principal Investigator: Adriano Lazzarin, MD IRCCS San Raffaele Hospital
More Information

More Information


Responsible Party: adriano lazzarin, IRCCS San Raffaele  
ClinicalTrials.gov Identifier: NCT00437476   History of Changes  
Other Study ID Numbers: Kamon 1  
Study First Received: February 20, 2007  
Last Updated: February 5, 2009  

Keywords provided by IRCCS San Raffaele:

HIV/HCV
HIV and HCV coinfected patients
Treatment Naive

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
HIV Infections
Ribavirin
Ritonavir
Lopinavir
Interferon-alpha
Peginterferon alfa-2a
Reverse Transcriptase Inhibitors
Hepatitis C Antibodies

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.