Kaletra Monotherapy in HIV/HCV Co-infected Subjects - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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.

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lopinavir

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
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 ] [ 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

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)

Intervention Details:

Kaletra 800/200 OD

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

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.
Subject is both HIV positive and HCV positive (must be viremic for HCV, not just antibody positive).
Subject is 18 years of age or older.
Subject must have an undetectable viral load (VL) less than 50 copies/ml for the last 6 months on HAART therapy.
Subject must not be taking any medication that could interact with Kaletra® to enhance hepatic toxicity.
Subject's serum AST and ALT levels must be <5 times normal (grade 2 or less) at the start of the study.
Subject must not harbour viral strains that are resistant to Kaletra® at the start of the study.
Subject has a Karnofsky Score 70 or greater.
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.
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

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

Locations

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

Principal Investigator:

Curtis Cooper, MD

OHRI

More Information

No publications provided

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
Health Authority:	Canada: Health Canada Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:

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

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2013