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Trial record 1 of 2 for:    kaletra hcv hiv canada
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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
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Kaletra Tablets Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
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.
Study Start Date : June 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Intervention Details:
  • Drug: Kaletra Tablets
    Kaletra 800/200 OD

Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

  2. To study compliance of subjects [ Time Frame: 48 weeks ]
    adherence assessed at each study visit


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

  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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6Z 2C7
Canada, Ontario
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Abbott
Investigators
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Principal Investigator: Curtis Cooper, MD OHRI
More Information
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00508222    
Other Study ID Numbers: 2007217-01H
A06-321
First Posted: July 27, 2007    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012
Keywords provided by Ottawa Hospital Research Institute:
HIV
HCV
HIV/HCV Co-infection
Kaletra Monotherapy
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases