A randomized study of pharmacokinetics, efficacy, and safety of 2 raltegravir plus atazanavir strategies in ART-treated adults
| Autor: | Mark Bloch, David A. Cooper, Sarah Pett, John E. Ray, Sean Emery, Handan Wand, Dianne Carey, Kate Beileiter, Karen MacRae, Mark A. Boyd |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
Male medicine.medical_specialty animal structures Drug-Related Side Effects and Adverse Reactions Anti-HIV Agents Pyridines Atazanavir Sulfate HIV Infections Pharmacology law.invention Cmin Plasma Pharmacokinetics Randomized controlled trial law Internal medicine Antiretroviral Therapy Highly Active Raltegravir Potassium Medicine Humans Pharmacology (medical) Adverse effect business.industry Middle Aged Raltegravir Confidence interval Pyrrolidinones Atazanavir Infectious Diseases Treatment Outcome Ritonavir business human activities Oligopeptides medicine.drug |
| Zdroj: | Journal of acquired immune deficiency syndromes (1999). 60(2) |
| ISSN: | 1944-7884 |
| Popis: | Background: New antiretroviral drug classes provide opportunities to explore novel regimens. Methods: HIV+ adults (l50 copies/mL) receiving atazanavir (ATV) were randomized to raltegravir (RAL) 400 mg + ATV 300 mg twice daily (q12h) for 4 weeks followed by RAL 800 mg + ATV/ritonavir 300/100 mg once daily (q24h) for 4 weeks or vice versa. Validated assays quantitated RAL and ATV plasma concentrations. Primary endpoint was geometric mean ratio (GMR) of ATV minimum concentration (Cmin) for q24h/q12h. Equivalence was 90% confidence interval (CI) of GMR lying between 0.80 and 1.25. Participants could consent to a total 48-week follow-up. Results: Twenty-five men, mean age 45 (range, 35-57) years, were evaluated. ATV and RAL demonstrated considerable pharmacokinetic variability. There was no period or sequence effect for pharmacokinetic parameters (P g 0.1 all measures). Ninety percent CIs of ATV GMR Cmin [1.30 (90% CI: 1.08 to 1.58)] and RAL GMR Cmin [0.48 (90% CI: 0.31 to 0.75)] demonstrated nonequivalence. Seventy-six percent consented to follow-up. There were no serious adverse events and no discontinuations due to adverse events over 48 weeks; HIV RNA remained undetectable. Conclusions: In virologically suppressed adults, regimens comprising ATV plus RAL were efficacious and safe. ATV q12h troughs were lower than ritonavir-boosted atazanavir q24h; RAL q24h troughs were lower than q12h. |
| Databáze: | OpenAIRE |
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