We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

NRTI-Sparing Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00143689
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : September 26, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
HIV Mitochondrial Toxicity Drug: lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of a Nucleoside Analogue Reverse Transcriptase Inhibitor Sparing Regimen in Antiretroviral-Naïve, HIV-infected Patients
Study Start Date : April 2002
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143689


Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
University of Ottawa Health Services
Ottawa, Ontario, Canada
Maple Leaf Clinic
Toronto, Ontario, Canada
Canada, Quebec
Clinique Medicale L'Actuel
Montreal, Quebec, Canada
Sponsors and Collaborators
University of British Columbia
Abbott
Boehringer Ingelheim
CIHR Canadian HIV Trials Network
Investigators
Principal Investigator: Julio Montaner, MD University of British Columbia/Providence Health Care
More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00143689     History of Changes
Other Study ID Numbers: H02-50066
CTN 177
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: September 26, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Ritonavir
Lopinavir
Lamivudine
Zidovudine
Nevirapine
Reverse Transcriptase Inhibitors
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors
Antimetabolites
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers