High-dose lopinavir/ritonavir in highly treatment-experienced HIV-1 patients: Efficacy, safety, and predictors of response

Daniel Podzamczer, Martin S. King, Cheri E. Klein, Charles Flexner, Christine Katlama, Diane V. Havlir, Scott L. Letendre, Joseph J. Eron, Scott C. Brun, Barry Bernstein

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: 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. Method: 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 levels <50 copies/mL at week 24 and time until loss of virologic response through week 48. Results: 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 RNA <50 copies/mL at least once; 18% (400/300 mg) and 21% (667/167 mg) of subjects achieved HIV-1 RNA <50 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. Conclusion: Higher doses of LPV/r may provide substantial antiviral activity in multiple class-experienced subjects.

Original languageEnglish (US)
Pages (from-to)193-204
Number of pages12
JournalHIV Clinical Trials
Volume8
Issue number4
DOIs
StatePublished - Jul 2007

Keywords

  • HIV
  • Lopinavir
  • Resistance
  • Ritonavir

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

Fingerprint

Dive into the research topics of 'High-dose lopinavir/ritonavir in highly treatment-experienced HIV-1 patients: Efficacy, safety, and predictors of response'. Together they form a unique fingerprint.

Cite this