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Kaletra Monotherapy in HIV/HCV Co-infected Subjects

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Kaletra Tablets
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, HCV, HIV/HCV Co-infection, Kaletra Monotherapy, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Subject has confirmed his or her willingness to participate in the study after being informed of all aspects of the trial that are relevant to his or her decision to participate, by signing and dating the IRB / IEC approved informed consent form.
  2. Subject is both HIV positive and HCV positive (must be viremic for HCV, not just antibody positive).
  3. Subject is 18 years of age or older.
  4. Subject must have an undetectable viral load (VL) less than 50 copies/ml for the last 6 months on HAART therapy.
  5. Subject must not be taking any medication that could interact with Kaletra® to enhance hepatic toxicity.
  6. Subject's serum AST and ALT levels must be <5 times normal (grade 2 or less) at the start of the study.
  7. Subject must not harbour viral strains that are resistant to Kaletra® at the start of the study.
  8. Subject has a Karnofsky Score 70 or greater.
  9. If female, subject must have a negative pregnancy test and agree to use, for the duration of the study, a barrier method of birth control that has a history of proven reliability as judged by the investigator.
  10. Subject does not require and agrees not to take, for the duration of the study, any medication that is contraindicated with Kaletra® (list will be in the protocol).

Exclusion Criteria

  1. Subject has active hepatitis B (HbsAg +).
  2. Subject has a history of substance abuse or psychiatric illness that could preclude compliance with the protocol.

  3. Subject has any of the following abnormal laboratory test results at screening:

    • Hemoglobin 8.0 g/dL or more
    • Absolute neutrophil count 500 cells/mL or more
    • Platelet count 20,000/mL or more
    • ALT or AST 5x Upper Limit of Normal (ULN) or more
    • Creatinine 1.5 x ULN or more
  4. Female subject is pregnant or lactating.
  5. Subject has received an investigational drug within 30 days prior to the initiation of study dosing.
  6. Subject exhibits viral strains that are resistant to lopinavir.
  7. Subject is receiving systemic chemotherapy.
  8. The subject, in the opinion of the principal investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.

Sites / Locations

  • University of British Columbia
  • The Ottawa Hospital, General Campus

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
PK measured at week 4 and 24
To study compliance of subjects
adherence assessed at each study visit

Full Information

First Posted
July 25, 2007
Last Updated
May 28, 2012
Sponsor
Ottawa Hospital Research Institute
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00508222
Brief Title
Kaletra Monotherapy in HIV/HCV Co-infected Subjects
Official Title
A Pilot, Prospective, Open-label Study to Evaluate the Safety and Efficacy of Kaletra® Monotherapy in HIV/HCV Co-infected Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, HCV, HIV/HCV Co-infection, Kaletra Monotherapy, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Kaletra Tablets
Intervention Description
Kaletra 800/200 OD
Primary Outcome Measure Information:
Title
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.
Description
patients on cART switched to Kaletra monotherapy an monitored for 48 weeks thereafter
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
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)
Description
PK measured at week 4 and 24
Time Frame
24 weeks
Title
To study compliance of subjects
Description
adherence assessed at each study visit
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subject has confirmed his or her willingness to participate in the study after being informed of all aspects of the trial that are relevant to his or her decision to participate, by signing and dating the IRB / IEC approved informed consent form. Subject is both HIV positive and HCV positive (must be viremic for HCV, not just antibody positive). Subject is 18 years of age or older. Subject must have an undetectable viral load (VL) less than 50 copies/ml for the last 6 months on HAART therapy. Subject must not be taking any medication that could interact with Kaletra® to enhance hepatic toxicity. Subject's serum AST and ALT levels must be <5 times normal (grade 2 or less) at the start of the study. Subject must not harbour viral strains that are resistant to Kaletra® at the start of the study. Subject has a Karnofsky Score 70 or greater. If female, subject must have a negative pregnancy test and agree to use, for the duration of the study, a barrier method of birth control that has a history of proven reliability as judged by the investigator. Subject does not require and agrees not to take, for the duration of the study, any medication that is contraindicated with Kaletra® (list will be in the protocol). Exclusion Criteria Subject has active hepatitis B (HbsAg +). Subject has a history of substance abuse or psychiatric illness that could preclude compliance with the protocol. Subject has any of the following abnormal laboratory test results at screening: Hemoglobin 8.0 g/dL or more Absolute neutrophil count 500 cells/mL or more Platelet count 20,000/mL or more ALT or AST 5x Upper Limit of Normal (ULN) or more Creatinine 1.5 x ULN or more Female subject is pregnant or lactating. Subject has received an investigational drug within 30 days prior to the initiation of study dosing. Subject exhibits viral strains that are resistant to lopinavir. Subject is receiving systemic chemotherapy. The subject, in the opinion of the principal investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtis Cooper, MD
Organizational Affiliation
OHRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C7
Country
Canada
Facility Name
The Ottawa Hospital, General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada

12. IPD Sharing Statement

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Kaletra Monotherapy in HIV/HCV Co-infected Subjects

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