Kaletra Monotherapy in HIV/HCV Co-infected Subjects
The study has been designed to test the hypothesis that in patients co-infected with HIV and HCV who exhibit maximal virologic suppression on a double class antiretroviral (ARV) regimen, including two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and a Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) or a Protease Inhibitor (PI) (boosted or not with ritonavir), simplification of highly active antiretroviral therapy (HAART) to Kaletra® monotherapy will represent a viable strategy without any negative impact on the virologic control of HIV infection.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot, Prospective, Open-label Study to Evaluate the Safety and Efficacy of Kaletra® Monotherapy in HIV/HCV Co-infected Subjects.|
- The primary objective of this study is to assess the safety and efficacy of Kaletra® (lopinavir/ritonavir) monotherapy in the treatment of patients co-infected with HIV and HCV. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]patients on cART switched to Kaletra monotherapy an monitored for 48 weeks thereafter
- To investigate and compare the pharmacokinetics (PK) of Kaletra® monotherapy at steady-state between co-infected subjects with advanced liver fibrosis (stage 3-4) and those with minimal liver disease (stage 0-2) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]PK measured at week 4 and 24
- To study compliance of subjects [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]adherence assessed at each study visit
|Study Start Date:||June 2007|
|Study Completion Date:||April 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Drug: Kaletra Tablets
The primary purpose of this study is to determine how safe and effective the drug Kaletra® is in treating HIV when it is administered without any other antiretroviral drugs (monotherapy). Kaletra® is 2 protease inhibitors (lopinavir and ritonavir) combined in one dosage form.
Kaletra monotherapy is experimental and subjects eligible to the study are switching from a successful conventional triple therapy to an unproven experimental therapy.
Approximately 40 HIV/HCV coinfected participants, aged over 18 years will participate in this study.
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada, V6Z 2C7|
|The Ottawa Hospital, General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|Principal Investigator:||Curtis Cooper, MD||OHRI|