title: A controlled trial of nevirapine plus zidovudine versus zidovudine alone in p24 antigenaemic HIV-infected patients. The Dutch-Italian-Australian Nevirapine Study Group.
abstract: OBJECTIVE
  Nevirapine is a non-nucleoside reverse transcriptase inhibitor of HIV-1 which exhibits synergy in vitro with zidovudine (ZDV) and also is active against ZDV-resistant HIV. We evaluated the activity and safety of nevirapine in combination with ZDV in patients receiving long-term ZDV therapy.
  
  
  METHODS
  We conducted a randomized, open-label, controlled 28-week study of nevirapine (200 mg daily for 2 weeks followed by 200 mg twice daily for 26 weeks) and continued ZDV (500-600 mg daily) versus continued ZDV alone in 49 HIV-1 p24 antigenaemic patients with CD4+ lymphocyte counts < 500 x 10(6)/l and who had been treated with ZDV for at least 6 months.
  
  
  RESULTS
  Addition of nevirapine to ZDV resulted in a significant and rapid reduction in circulating RNA load (mean, 0.65), a mean CD4+ lymphocyte rise of 34 x 10(6)/l, a reduction in serum beta 2-microglobulin and a median fall in immune complex dissociated p24 antigen levels of 69%. These changes remained statistically significant for 4, 4, 12 and at least 28 weeks, respectively. The principal adverse event due to nevirapine was a hypersensitivity reaction comprising rash with or without fever and mucositis in eight (32%) patients, which was dose-limiting in seven patients.
  
  
  CONCLUSIONS
  Nevirapine exhibits significant although transient anti-HIV activity in ZDV-pretreated patients but its use is frequently associated with a hypersensitivity reaction.
authors.affiliation: HIV Medicine Unit, St. Vincent's Hospital, Sydney, Australia.
authors.forename: A
authors.initials: A
authors.lastname: Carr
authors.forename: S
authors.initials: S
authors.lastname: Vella
authors.forename: M D
authors.initials: MD
authors.lastname: de Jong
authors.forename: F
authors.initials: F
authors.lastname: Sorice
authors.forename: A
authors.initials: A
authors.lastname: Imrie
authors.forename: C A
authors.initials: CA
authors.lastname: Boucher
authors.forename: D A
authors.initials: DA
authors.lastname: Cooper
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016655:HIV Core Protein p24 / Q000276:immunology*; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D015497:HIV-1 / Q000276:immunology; D006801:Humans; D008297:Male; D019829:Nevirapine; D011725:Pyridines / Q000627:therapeutic use*; D015215:Zidovudine / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D016655:HIV Core Protein p24; D011725:Pyridines; D015215:Zidovudine; D019829:Nevirapine