Clinical Trials

MainTitle

Kaletra Monotherapy in HIV/HCV Co-infected Subjects

This study has been completed
Sponsor
Ottawa Hospital Research Institute

Collaborator
Abbott

Information provided by (Responsible Party)
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier
NCT00508222

First received: July 25, 2007
Last updated: May 28, 2012
Last Verified: May 2012
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : Kaletra Tablets
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.

Further study details as provided by Ottawa Hospital Research Institute:

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. [ Time Frame: 48 weeks ]
    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) [ 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

Enrollment: 22
Study Start Date: June 2007
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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
  • 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.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00508222

    Locations

    Canada
    University of British Columbia
    Vancouver, British Columbia, Canada, V6Z 2C7
    The Ottawa Hospital, General Campus
    Ottawa, Ontario, Canada, K1H 8L6

    Sponsors and Collaborators

    Ottawa Hospital Research Institute
    Abbott

    Investigators

    Principal Investigator: Curtis Cooper, MD OHRI
    More Information

    More Information


    Responsible Party: Ottawa Hospital Research Institute  
    ClinicalTrials.gov Identifier: NCT00508222   History of Changes  
    Other Study ID Numbers: 2007217-01H  
      A06-321  
    Study First Received: July 25, 2007  
    Last Updated: May 28, 2012  

    Keywords provided by Ottawa Hospital Research Institute:

    HIV
    HCV
    HIV/HCV Co-infection
    Kaletra Monotherapy
    Treatment Experienced

    Additional relevant MeSH terms:
    HIV Infections
    Lopinavir

    ClinicalTrials.gov processed this data on December 15, 2017
    This information is provided by ClinicalTrials.gov.