NRTI-Sparing Pilot Study

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ClinicalTrials.gov Identifier: NCT00143689

Recruitment Status : Completed

First Posted : September 2, 2005

Last Update Posted : September 26, 2014

Sponsor:

Collaborators:

Abbott

Boehringer Ingelheim

CIHR Canadian HIV Trials Network

Information provided by (Responsible Party):

University of British Columbia

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
Actual Primary Completion Date :	February 2008
Actual Study Completion Date :	February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Zidovudine Nevirapine Lamivudine Ritonavir Lopinavir

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 :

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 :

Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 96 weeks [ Time Frame: 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

Eligibility Criteria

Information from the National Library of Medicine

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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

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