title: Safety and antiviral activity at 48 weeks of lopinavir/ritonavir plus nevirapine and 2 nucleoside reverse-transcriptase inhibitors in human immunodeficiency virus type 1-infected protease inhibitor-experienced patients.
abstract: The safety and antiviral activity of lopinavir (Lpv), a protease inhibitor (PI) coformulated with ritonavir (Rtv) to enhance its pharmacokinetic properties, were evaluated in 70 patients with plasma human immunodeficiency virus type 1 (HIV-1) RNA levels of 1000-100,000 copies/mL on a first PI-containing regimen. Patients were randomized to substitute only the PI with Lpv/Rtv, 400/100 mg or 400/200 mg twice daily. On day 15, nevirapine (200 mg 2x/day) was added, and nucleoside reverse-transcriptase inhibitors were changed. Despite a >4-fold reduction in phenotypic susceptibility to the preentry PI in 63% of patients, mean plasma HIV-1 RNA levels declined by 1.14 log(10) copies/mL after 2 weeks of Lpv/Rtv. At week 48, 86% of subjects receiving treatment had plasma HIV-1 RNA levels of <400 copies/mL; 76% had levels <50 HIV-1 RNA copies/mL (intent-to-treat: 70% and 60%, respectively). Mean CD4 cell counts increased by 125 cells/muL. Three patients discontinued therapy for drug-related adverse events.
authors.affiliation: Department of Medicine, University of Colorado Health Sciences Center, 4200 E. 9th Avenue, B-168, Denver, CO 80262, USA. constance.benson@uchsc.edu
authors.forename: Constance A
authors.initials: CA
authors.lastname: Benson
authors.forename: Steven G
authors.initials: SG
authors.lastname: Deeks
authors.forename: Scott C
authors.initials: SC
authors.lastname: Brun
authors.forename: Roy M
authors.initials: RM
authors.lastname: Gulick
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Eron
authors.forename: Harold A
authors.initials: HA
authors.lastname: Kessler
authors.forename: Robert L
authors.initials: RL
authors.lastname: Murphy
authors.forename: Charles
authors.initials: C
authors.lastname: Hicks
authors.forename: Martin
authors.initials: M
authors.lastname: King
authors.forename: David
authors.initials: D
authors.lastname: Wheeler
authors.forename: Judith
authors.initials: J
authors.lastname: Feinberg
authors.forename: Richard
authors.initials: R
authors.lastname: Stryker
authors.forename: Paul E
authors.initials: PE
authors.lastname: Sax
authors.forename: Sharon
authors.initials: S
authors.lastname: Riddler
authors.forename: Melanie
authors.initials: M
authors.lastname: Thompson
authors.forename: Kathryn
authors.initials: K
authors.lastname: Real
authors.forename: Ann
authors.initials: A
authors.lastname: Hsu
authors.forename: Dale
authors.initials: D
authors.lastname: Kempf
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Japour
authors.forename: Eugene
authors.initials: E
authors.lastname: Sun
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000494:pharmacology / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000145:classification / Q000187:drug effects / Q000502:physiology; D006801:Humans; D061466:Lopinavir; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000494:pharmacology / Q000627:therapeutic use; D011446:Prospective Studies; D011744:Pyrimidinones / Q000494:pharmacology / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D018894:Reverse Transcriptase Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D019438:Ritonavir / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D011744:Pyrimidinones; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D061466:Lopinavir; D019829:Nevirapine; D019438:Ritonavir