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
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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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: Lopinavir/ritonavir, Zidovudine, Lamivudine
Participants will be randomly assigned to receive one of the following drug combinations:
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Drug: lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine
See Detailed Description.
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- Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity. [ Time Frame: 48 weeks ]
- 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

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 |
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

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