NRTI-Sparing Pilot Study

September 25, 2014 updated by: University of British Columbia

A Pilot Study of a Nucleoside Analogue Reverse Transcriptase Inhibitor Sparing Regimen in Antiretroviral-Naïve, HIV-infected Patients

This study will compare a nucleoside reverse transcriptase inhibitor-sparing (NRTI-sparing) regimen (Kaletra + nevirapine) to two nucleoside reverse transcriptase inhibitor-based regimens (Combivir + nevirapine and Combivir + Kaletra).

Participants will be randomly assigned to receive one of the following drug combinations:

  • lopinavir/ritonavir (Kaletra) and nevirapine (Viramune) twice a day;
  • Combivir (Zidovudine (AZT) plus lamivudine (3TC)) and nevirapine twice a day;
  • Combivir and lopinavir/ritonavir twice a day.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • McMaster University
      • Ottawa, Ontario, Canada
        • University of Ottawa Health Services
      • Toronto, Ontario, Canada
        • Maple Leaf Clinic
    • Quebec
      • Montreal, Quebec, Canada
        • Clinique médicale l'Actuel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Be HIV-positive
  • Be at least18 years of age
  • Have viral load above 5 000 copies/ml
  • Be likely to comply with the study protocol
  • Agree not to take, for the duration of the study, any drug that is contraindicated with the study drugs
  • Agree not to take any medication, including over-the-counter medicine, alcohol, or street drugs without the knowledge and permission of the principal investigator

Exclusion Criteria:

  • Have ever received antiretroviral therapy
  • Pregnancy or breastfeeding
  • Have abnormal laboratory tests (see investigator)
  • Have received an investigational drug within 30 days of study drugs administration
  • Be receiving systemic chemotherapy
  • Have an acute illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lopinavir/ritonavir, Zidovudine, Lamivudine

Participants will be randomly assigned to receive one of the following drug combinations:

  • lopinavir/ritonavir (Kaletra) and nevirapine (Viramune) twice a day;
  • Combivir (Zidovudine (AZT) plus lamivudine (3TC)) and nevirapine twice a day;
  • Combivir and lopinavir/ritonavir twice a day.
Drug: lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine
See Detailed Description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity.
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 96 weeks
Time Frame: 96 weeks
96 weeks
Proportions of patients with viral load below 50 and below 400 copies/mL
Viral load changes from baseline
Rates and extent of immune reconstitution (CD4 count increase)
Rates and severity of dyslipidemia and insuline resistance/diabetes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Boehringer Ingelheim
Abbott
CIHR Canadian HIV Trials Network

Investigators

  • Principal Investigator: Julio Montaner, MD, University of British Columbia/Providence Health Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

September 26, 2014

Last Update Submitted That Met QC Criteria

September 25, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H02-50066
  • CTN 177

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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