NCT00508222

Kaletra Monotherapy in HIV/HCV Co-infected Subjects

A Pilot, Prospective, Open-label Study to Evaluate the Safety and Efficacy of Kaletra® Monotherapy in HIV/HCV Co-infected Subjects.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Kaletra Tablets	Kaletra 800/200 OD

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-03-01
• Completion: 2011-04-01
• First posted: 2007-07-27
• Last updated: 2012-05-30

Locations

2 sites across 1 country: Canada