Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437476
Status:
UNKNOWN
Last Update Posted:
2009-02-06
First Post:
2007-02-20
Brief Title:
LopinavirRitonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy HAART in HIVHCV Coinfected Antiretroviral ARV Naive Patients Starting Treatment With Anti-HCV Therapy
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Pilot Multicenter Randomized Study on LopinavirRitonavir-Monotherapy vs LopinavirRitonavir Plus Selected Nucs in HIVHCV ARV-Naive Coinfected Patients With Chronic Hepatitis C or Compensated Cirrhosis Starting Treatment With Ribavirin and Pegylated Interferon
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate if the combination of Lpvr 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 Lpvr monotherapy during HCV-treatment is associated with HIV efficacy vs optimized HAART
Secondary objective is to assess if Lpvr 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 resistancewill receive 26 weeks induction HAART LPVr selected NUCS At the end of induction period Phase I all subjects with negative HIV-RNA from at least two months Hb 11 gdL and CD4 count 350 cellsmmc will be randomised 11 to receive LPVr new tabs 20050 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 LPVr selected NRTIs for 26 weeks followed by LPVr monotherapy and anti HCV drugs for 48 weeks Group B will receive LPVr 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 HCVHIV each subject will be treated for HIV infection according to physician decisionAll the patients will be followed-up for 24 weeks after the end of anti-HCV drugs for the evaluation of SVRAs anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcgweek Ribavirin 1-12 gday At the end of week 12 of combined therapy only patients who will reach an early virological response will continue anti-HCV drugs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None