title: Pharmacokinetics of the HIV integrase inhibitor S/GSK1349572 co-administered with acid-reducing agents and multivitamins in healthy volunteers.
abstract: OBJECTIVE
  To evaluate the effect of pH-altering agents on S/GSK1349572 exposure in healthy subjects.
  
  
  METHODS
  S/GSK1349572 is an unboosted, once-daily, next-generation HIV integrase inhibitor. In the first study, 16 subjects received four single-dose treatments: (i) S/GSK1349572 50 mg; (ii) S/GSK1349572 50 mg with a multivitamin (MVI; One A Day Maximum); (iii) S/GSK1349572 50 mg with a liquid antacid (Maalox Advanced Maximum Strength); and (iv) S/GSK1349572 50 mg 2 h before an antacid. In the second study, 12 subjects received a single dose of S/GSK1349572 alone and on day 5 of omeprazole.
  
  
  RESULTS
  All treatments were well tolerated. MVI co-administration modestly decreased S/GSK1349572 AUC by 33%. Concurrent antacid co-administration reduced S/GSK1349572 AUC by 74% and staggered antacid dosing significantly diminished this interaction, with a reduction in S/GSK1349572 AUC of 26%. Omeprazole did not significantly affect S/GSK1349572 exposure.
  
  
  CONCLUSIONS
  S/GSK1349572 can be taken with proton pump inhibitors and MVIs without dose adjustment but should be administered 2 h before or 6 h after antacids.
authors.affiliation: GlaxoSmithKline, Research Triangle Park, NC, USA.
authors.forename: Parul
authors.initials: P
authors.lastname: Patel
authors.forename: Ivy
authors.initials: I
authors.lastname: Song
authors.forename: Julie
authors.initials: J
authors.lastname: Borland
authors.forename: Apurva
authors.initials: A
authors.lastname: Patel
authors.forename: Yu
authors.initials: Y
authors.lastname: Lou
authors.forename: Shuguang
authors.initials: S
authors.lastname: Chen
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Wajima
authors.forename: Amanda
authors.initials: A
authors.lastname: Peppercorn
authors.forename: Sherene S
authors.initials: SS
authors.lastname: Min
authors.forename: Stephen C
authors.initials: SC
authors.lastname: Piscitelli
mesh_terms: D000328:Adult; D000863:Antacids / Q000008:administration & dosage*; D000873:Anthracenes / Q000009:adverse effects / Q000493:pharmacokinetics*; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D005260:Female; D064368:Healthy Volunteers; D006575:Heterocyclic Compounds, 3-Ring; D006801:Humans; D008297:Male; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D014815:Vitamins / Q000008:administration & dosage*; D000099226:Dolutegravir
chemical_list: D000863:Antacids; D000873:Anthracenes; D019380:Anti-HIV Agents; D006575:Heterocyclic Compounds, 3-Ring; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D014815:Vitamins; D000099226:Dolutegravir