Document 1105 DOCN M94A1105 TI Antiviral response to nevirapine monotherapy in nucleoside naive persons. Dutch-Italian-Australian Nevirapine Study Group. DT 9412 AU de Jong M; NATEC, Amsterdam, The Netherlands. SO Int Conf AIDS. 1994 Aug 7-12;10(2):208 (abstract no. PB0847). Unique Identifier : AIDSLINE ICA10/94371470 AB OBJECTIVE: Assess safety and antiretroviral activity of nevirapine (nvp) at a dosage of 400 mg/day in p24 antigenemic nucleoside naive patients. METHODS: Twenty p24 antigen positive males who had not received prior antiretroviral treatment were treated with nvp 200 mg/day for two weeks, followed by nvp 400 mg/day. Median values of baseline CD4+ cell counts and p24 antigen levels were 248 cells/mm3 (range 74-419), and 61 pg/ml (range 22-507) respectively. Antiretroviral activity was evaluated in terms of p24 antigen levels and CD4+ cell counts. Additional RNA load and resistance studies were planned. RESULTS: Rash and liver enzyme abnormalities were observed resulting in premature discontinuation in 4 patients. During the first four weeks of treatment, 18/20 patients reached 50% declines in p24 antigen levels. However, the duration of p24 antigen declines was variable: after 16, 20 and 24 weeks of treatment, p24 antigen levels were still 50% below baseline values in respectively 9/14, 5/11, and 2/7 patients. A transient increase in median CD4+ count was followed by a return to baseline values within 12 weeks. Follow-up data up to 24 weeks will be presented. CONCLUSION: Nevirapine 400 mg results in p24 antigen declines of variable duration. Further research will be presented, evaluating whether virologic, host, or pharmacokinetic factors can predict duration of response. DE Antiviral Agents/*THERAPEUTIC USE Human HIV Core Protein p24/*ANALYSIS HIV Infections/*DRUG THERAPY/IMMUNOLOGY/MICROBIOLOGY Leukocyte Count Male Pyridines/*THERAPEUTIC USE T4 Lymphocytes MEETING ABSTRACT SOURCE: National Library of Medicine. NOTICE: This material may be protected by Copyright Law (Title 17, U.S.Code).