Nevirapine (NVP) alone and in combination with zidovudine (ZDV): safety and activity. The ACTG 164/168 Study Team.

Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.

Nevirapine (NVP) alone and in combination with zidovudine (ZDV): safety and activity. The ACTG 164/168 Study Team.

Int Conf AIDS. 1992 Jul 19-24;8(1):Mo15 (abstract no. MoB 0053). Unique Identifier : AIDSLINE ICA8/92400012
Cheeseman SH; U Mass, Worcester.

Abstract: OBJECTIVES: To determine safety and activity of NVP in HIV-infected persons (HIVP). METHODS: Sequential cohorts of HIVP received daily doses of 12.5, 50, 200, and 400 mg NVP, alone or in combination with ZDV 200 mg p.o. q8h. Plasma levels of NVP and ZDV were assayed by HPLC. HIV p24 antigen was measured after acid hydrolysis in patients with values less than 40 pg/ml in the conventional assay. Quantitative plasma viremia, endpoint dilution cell culture, CD4 counts, and routine chemistry and hematology values were monitored. TABULAR DATA, SEE ABSTRACT VOLUME. P24 usually decreased in the first week but rapidly rose again in most patients. 2/5 on 200 mg NVP alone and 3/5 on 200 mg NVP + 600 mg ZDV had p24 levels less than 50% baseline at 6 wks. No consistent CD4 responses occurred. Several patients in the 400 mg group had dose-limiting rashes but NVP was otherwise very well tolerated. CONCLUSIONS: 1. p24 suppression increased with increasing doses of nevirapine but was rarely sustained. 2. NVP was well tolerated. 3. Further studies with the 400 mg dose are ongoing.

Keywords: Azepines/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE Cohort Studies Comparative Study Drug Therapy, Combination Human HIV Core Protein p24/BLOOD HIV Infections/*DRUG THERAPY Pyridines/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE Viremia/DRUG THERAPY Zidovudine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE ABSTRACT
921230
M92C5335

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