Kaletra Monotherapy in HIV/HCV Co-infected Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00508222|
Recruitment Status : Completed
First Posted : July 27, 2007
Last Update Posted : May 30, 2012
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Kaletra Tablets||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot, Prospective, Open-label Study to Evaluate the Safety and Efficacy of Kaletra® Monotherapy in HIV/HCV Co-infected Subjects.|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||April 2011|
- Drug: Kaletra Tablets
Kaletra 800/200 OD
- 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 ]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 ]PK measured at week 4 and 24
- To study compliance of subjects [ Time Frame: 48 weeks ]adherence assessed at each study visit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508222
|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|