NRTI-Sparing Pilot Study
Phase 4
Completed
- Conditions
- HIVMitochondrial Toxicity
- Interventions
- Registration Number
- NCT00143689
- Lead Sponsor
- University of British Columbia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lopinavir/ritonavir, Zidovudine, Lamivudine lopinavir/ritonavir; nevirapine; 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.
- Primary Outcome Measures
Name Time Method Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity. 48 weeks
- Secondary Outcome Measures
Name Time Method Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 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
Trial Locations
- Locations (4)
McMaster University
🇨🇦Hamilton, Ontario, Canada
University of Ottawa Health Services
🇨🇦Ottawa, Ontario, Canada
Clinique Medicale L'Actuel
🇨🇦Montreal, Quebec, Canada
Maple Leaf Clinic
🇨🇦Toronto, Ontario, Canada