Kaletra Monotherapy in HIV/HCV Co-infected Subjects

Phase 3

Completed

• Conditions: HIV Infections

• Registration Number: NCT00508222
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-25
• Study First Submitted QC: 2007-07-26
• Study First Posted: 2007-07-27
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-28
• Last Update Posted: 2012-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	48 weeks	patients on cART switched to Kaletra monotherapy an monitored for 48 weeks thereafter

Secondary Outcome Measures

Name	Time	Method
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)	24 weeks	PK measured at week 4 and 24
To study compliance of subjects	48 weeks	adherence assessed at each study visit

Trial Locations

Locations (2)

The Ottawa Hospital, General Campus; 🇨🇦 Ottawa, Ontario, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada