OBJECTIVES: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 withZDV 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. CONCLUSION:Nevirapine exhibits significant although transient anti-HIV activity in ZDV-pretreated patients but its use is frequently associated with a hypersensitivity reaction.
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OBJECTIVES: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-1p24 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. CONCLUSION:Nevirapine exhibits significant although transient anti-HIV activity in ZDV-pretreated patients but its use is frequently associated with a hypersensitivity reaction.
Authors: L T Bacheler; E D Anton; P Kudish; D Baker; J Bunville; K Krakowski; L Bolling; M Aujay; X V Wang; D Ellis; M F Becker; A L Lasut; H J George; D R Spalding; G Hollis; K Abremski Journal: Antimicrob Agents Chemother Date: 2000-09 Impact factor: 5.191
Authors: V Joly; M Moroni; E Concia; A Lazzarin; B Hirschel; J Jost; F Chiodo; Z Bentwich; W C Love; D A Hawkins; E G Wilkins; A J Gatell; N Vetter; C Greenwald; W W Freimuth; W de Cian Journal: Antimicrob Agents Chemother Date: 2000-11 Impact factor: 5.191
Authors: Monique M R de Maat; Rob ter Heine; Jan W Mulder; Pieter L Meenhorst; Albert T A Mairuhu; Eric C M van Gorp; Alwin D R Huitema; Jos H Beijnen Journal: Eur J Clin Pharmacol Date: 2003-08-12 Impact factor: 2.953
Authors: Joy Y Feng; John K Ly; Florence Myrick; Derrick Goodman; Kirsten L White; Evguenia S Svarovskaia; Katyna Borroto-Esoda; Michael D Miller Journal: Retrovirology Date: 2009-05-13 Impact factor: 4.602