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	Intervention	Phase
HIV Mitochondrial Toxicity	Drug: lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine	Phase IV

Further Study Details: 

Primary Outcomes: Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity.
Secondary Outcomes: Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 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
Expected Total Enrollment:  76

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Canada, Ontario
      University of Ottawa Health Services, Ottawa,  Ontario,  Canada
      Maple Leaf Clinic, Toronto,  Ontario,  Canada
      McMaster University, Hamilton,  Ontario,  Canada
Canada, Quebec
      Clinique Medicale L’Actuel, Montreal,  Quebec,  Canada

Study chairs or principal investigators

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

Study ID Numbers:  P02-0066; CTN 177
Last Updated:  September 12, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00143689
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13