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Kaletra Monotherapy in HIV/HCV Co-infected Subjects

This study has been completed.
Sponsor:
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

July 25, 2007
May 28, 2012
June 2007
March 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
patients on cART switched to Kaletra monotherapy an monitored for 48 weeks thereafter
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.
Complete list of historical versions of study NCT00508222 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    PK measured at week 4 and 24
  • To study compliance of subjects [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    adherence assessed at each study visit
  • 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)
  • To study compliance of subjects c
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Kaletra Tablets
Kaletra 800/200 OD
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
April 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00508222
2007217-01H, A06-321
No
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Abbott
Principal Investigator: Curtis Cooper, MD OHRI
Ottawa Hospital Research Institute
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP