High-Dose Lopinavir/Ritonavir in Highly Treatment-Experienced HIV-1 Patients: Efficacy, Safety, and Predictors of Response
| Autor: | Christine Katlama, Diane V. Havlir, Scott C. Brun, Charles Flexner, Scott Letendre, Barry Bernstein, Daniel Podzamczer, Cheri E. Klein, Joseph J. Eron, Martin S. King |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
Adult
Male medicine.medical_specialty Human immunodeficiency virus (HIV) Lopinavir/ritonavir HIV Infections Pyrimidinones Pharmacology medicine.disease_cause Gastroenterology Drug Administration Schedule Lopinavir Treatment experienced Nucleoside Reverse Transcriptase Inhibitor Antiretroviral Therapy Highly Active Internal medicine Drug Resistance Viral Humans Medicine Pharmacology (medical) Protease inhibitor (pharmacology) Ritonavir Reverse-transcriptase inhibitor business.industry virus diseases HIV Protease Inhibitors Middle Aged Viral Load CD4 Lymphocyte Count Infectious Diseases HIV-1 RNA Viral Drug Therapy Combination Female business medicine.drug |
| Zdroj: | HIV Clinical Trials. 8:193-204 |
| ISSN: | 1945-5771 1528-4336 |
| Popis: | To investigate the efficacy and safety of high-dose lopinavir/ritonavir (LPV/r) therapy in multiple protease inhibitor, non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced subjects.Thirty-six HIV-1-infected subjects were randomized to LPV/r 400/300 mg or 667/167 mg bid in a 48-week, open-label study. Subjects also received investigator-selected nucleoside reverse transcriptase inhibitors (NRTIs). Primary outcomes were the proportion of subjects with HIV-1 RNA levels50 copies/mL at week 24 and time until loss of virologic response through week 48.Six of 17 (35%) and 10 of 19 (53%) subjects in the 400/300 and 667/167 groups, respectively, completed 48 weeks of treatment. Median durations of follow-up in discontinued subjects and all subjects were 15 weeks and 32 weeks, respectively. Forty-four percent of subjects achieved HIV-1 RNA50 copies/mL at least once; 18% (400/300 mg) and 21% (667/167 mg) of subjects achieved HIV-1 RNA50 copies/mL at week 24 (intent-to-treat analysis). Corresponding results at week 48 were 18% (400/300 mg) and 26% (667/167 mg). No statistically significant differences in adverse event incidence occurred between treatment groups, except for a higher vomiting rate in the 400/300 mg dose group. Predictors of response included baseline LPV inhibitory quotient and number of active NRTIs.Higher doses of LPV/r may provide substantial antiviral activity in multiple class-experienced subjects. |
| Databáze: | OpenAIRE |
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