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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Kaletra Tablets

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 weeks
To study compliance of subjects	adherence assessed at each study visit	48 weeks

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Abbott
• Investigators: Principal Investigator: Curtis Cooper, MD, OHRI

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: July 25, 2007
• First Submitted That Met QC Criteria: July 26, 2007
• First Posted (Estimate): July 27, 2007

Study Record Updates

• Last Update Posted (Estimate): May 30, 2012
• Last Update Submitted That Met QC Criteria: May 28, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: HIV; HCV; Treatment Experienced; HIV/HCV Co-infection; Kaletra Monotherapy
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 2007217-01H; A06-321