HIV, Mitochondrial Toxicity
Conditions
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.
Interventions
DRUGlopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine
See Detailed Description.
Sponsors
Abbott
Boehringer Ingelheim
CIHR Canadian HIV Trials Network
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity. | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada
Outcome results
None listed