title: A prospective study of efficacy and safety of once-daily saquinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors in treatment-naive Thai patients.
abstract: OBJECTIVE
  To assess the efficacy and safety of first-line treatment with once-daily saquinavir/ritonavir with two nucleoside reverse transcriptase inhibitors (NRTIs), as induction therapy before enrollment in a randomized trial of structured treatment interruption strategies.
  
  
  METHODS
  Two-hundred antiretroviral-naive patients with CD4+ cell counts between 200-350 at screening were enrolled in this open-label 24week study.
  
  
  METHODS
  Patients were followed up every 8 weeks for CD4+ cells, HIV RNA, and clinical and laboratory toxicities.
  
  
  RESULTS
  Two-hundred patients were enrolled with median baseline CD4+ cell count of 267 cells/microl and HIV RNA 50 118 (4.7 log10) copies/mi. After 24 weeks of treatment, 191 of 200 (96%) patients had below 400 copies/ml HIV RNA, with 177/200 (89%) below 50 copies/ml (intent to treat, missing equals failure method), with a median rise in CD4+ cell count of 122 cells/microl. There was no significant correlation between the minimum concentration of saquinavir and HIV RNA reductions at week 8 (P = 0.957) or absolute HIV RNA at week 24 (P = 0.77).
  
  
  CONCLUSIONS
  First-line highly active antiretroviral therapy (HAART) with once-daily saquinavir/ritonavir plus two NRTIs showed strong antiviral efficacy over 24 weeks, and should be evaluated in larger prospective randomized clinical trials.
authors.affiliation: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok, Thailand. jintanat.a@chula.ac.th
authors.forename: Jintanat
authors.initials: J
authors.lastname: Ananworanich
authors.forename: Andrew
authors.initials: A
authors.lastname: Hill
authors.forename: Umaporn
authors.initials: U
authors.lastname: Siangphoe
authors.forename: Kiat
authors.initials: K
authors.lastname: Ruxrungtham
authors.forename: Wisit
authors.initials: W
authors.lastname: Prasithsirikul
authors.forename: Ploenchan
authors.initials: P
authors.lastname: Chetchotisakd
authors.forename: Sasisopin
authors.initials: S
authors.lastname: Kiertiburanakul
authors.forename: Warangkana
authors.initials: W
authors.lastname: Munsakul
authors.forename: Phitsanu
authors.initials: P
authors.lastname: Raksakulkarn
authors.forename: Somboon
authors.initials: S
authors.lastname: Tansuphasawadikul
authors.forename: Reto
authors.initials: R
authors.lastname: Nuesch
authors.forename: David A
authors.initials: DA
authors.lastname: Cooper
authors.forename: Bernard
authors.initials: B
authors.lastname: Hirschel
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects*; D018791:CD4 Lymphocyte Count; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D019258:Saquinavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D013785:Thailand; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D019258:Saquinavir; D019438:Ritonavir