NRTI-Sparing Pilot Study

University of British Columbia13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Mitochondrial Toxicity

Interventions

lopinavir/ritonavir; nevirapine; Zidovudine; LamivudineDRUG

See Detailed Description.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

McMaster University

Hamilton, Ontario, Canada

University of Ottawa Health Services

Ottawa, Ontario, Canada

Maple Leaf Clinic

Toronto, Ontario, Canada

Clinique Medicale L'Actuel

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity.

Time frame: 48 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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