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CompletedNCT00508222Updated May 30, 2012

Kaletra Monotherapy in HIV/HCV Co-infected Subjects

A Phase 3 interventional study of Kaletra Tablets in HIV Infections, sponsored by Ottawa Hospital Research Institute. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-30.

Sponsored by Ottawa Hospital Research Institute · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
22
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • HIV
  • HCV
  • HIV/HCV Co-infection
  • Kaletra Monotherapy
  • Treatment Experienced
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 22 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Interventions

  • DrugKaletra Tablets

    Kaletra 800/200 OD

06

What researchers measure

Primary outcomes

  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.

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

    Time frame: 48 weeks

Secondary outcomes

  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)

    PK measured at week 4 and 24

    Time frame: 24 weeks

  2. To study compliance of subjects

    adherence assessed at each study visit

    Time frame: 48 weeks

07

Study locations

2 sites
  • University of British Columbia
    Vancouver, British Columbia V6Z 2C7, Canada
  • The Ottawa Hospital, General Campus
    Ottawa, Ontario K1H 8L6, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00508222
Lead sponsor
Ottawa Hospital Research Institute
Collaborators
Abbott
Responsible party
Sponsor
First posted
Jul 27, 2007
Start date
Jun 2007
Primary completion
Mar 2011
Completion
Apr 2011
Last update
May 30, 2012

Study contacts

Curtis Cooper, MD
principal investigator · OHRI

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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