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Lopinavir/ritonavir plus nevirapine as a nucleoside-sparing approach in antiretroviral-experienced patients (NEKA study).
- Source :
-
Journal of acquired immune deficiency syndromes (1999) [J Acquir Immune Defic Syndr] 2005 Jan 01; Vol. 38 (1), pp. 47-52. - Publication Year :
- 2005
-
Abstract
- Objectives: To compare the efficacy and safety of a nucleoside-sparing approach with a conventional highly active antiretroviral therapy (HAART) regimen in antiretroviral-experienced patients with prolonged viral suppression.<br />Methods: Pilot study including 31 antiretroviral-experienced patients with HIV RNA <80 copies/mL. Subjects were randomly assigned to lopinavir/ritonavir (LPV/rtv) 400/100 mg BID plus nevirapine (NVP) 200 mg BID (NVP group, n = 16) or LPV/rtv plus the 2 previous NRTIs (NRTI group, n = 15). The primary endpoint was the percentage of subjects who maintained viral suppression at week 48. Changes in lipid metabolism, mitochondrial parameters, and LPV trough levels were also assessed.<br />Results: All patients maintained viral suppression after 48 weeks. No subject discontinued therapy because of adverse events. HDL cholesterol increased by 28% at week 24 (P < 0.0001) and 10% after 48 weeks of follow-up (P = 0.319) in the NVP group. In the NRTI group, LDL cholesterol increased by 14% at week 48 (P = 0.076). Mitochondrial DNA/nuclear DNA ratio and mitochondrial respiratory chain complex IV activity showed a trend toward increasing in the NVP group. Mean (SD) LPV trough levels were 6340 (2129) ng/mL in the NRTI group and 5161 (2703) ng/mL in the NVP group (P = 0.140).<br />Conclusions: In antiretroviral-experienced subjects with sustained viral suppression, dual therapy with NVP plus LPV/rtv at standard dosage was as potent and safe as standard-of-care HAART at 48 weeks of follow-up. This approach may reduce mitochondrial toxicity and improve LPV/rtv-associated lipid abnormalities. The results of this pilot study support the study of this approach in a larger, randomized trial.
- Subjects :
- Adult
Anti-HIV Agents adverse effects
Anti-HIV Agents pharmacokinetics
Antiretroviral Therapy, Highly Active
Cholesterol, HDL blood
Cholesterol, LDL blood
Drug Tolerance
Female
HIV Infections metabolism
HIV Infections virology
HIV-Associated Lipodystrophy Syndrome etiology
Humans
Lipids blood
Lopinavir
Male
Middle Aged
Mitochondria drug effects
Mitochondria metabolism
Nevirapine adverse effects
Nevirapine pharmacokinetics
Prospective Studies
Pyrimidinones adverse effects
Pyrimidinones pharmacokinetics
Ritonavir adverse effects
Safety
Anti-HIV Agents administration & dosage
HIV Infections drug therapy
Nevirapine administration & dosage
Pyrimidinones administration & dosage
Ritonavir administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1525-4135
- Volume :
- 38
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Journal of acquired immune deficiency syndromes (1999)
- Publication Type :
- Academic Journal
- Accession number :
- 15608524
- Full Text :
- https://doi.org/10.1097/00126334-200501010-00009