Document 0190
 DOCN  M9550190
 TI    Phase I/II evaluation of nevirapine alone and in combination with
       zidovudine for infection with human immunodeficiency virus.
 DT    9505
 AU    Cheeseman SH; Havlir D; McLaughlin MM; Greenough TC; Sullivan JL; Hall
       D; Hattox SE; Spector SA; Stein DS; Myers M; et al; University of
       Massachusetts Medical School, Worcester.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Feb 1;8(2):141-51.
       Unique Identifier : AIDSLINE MED/95135992
 AB    In these Phase I/II open-label clinical trials, 62 persons with human
       immunodeficiency virus type 1 (HIV-1) infection and CD4+ cell counts <
       400/mm3 received nevirapine at doses of 12.5, 50, and 200 mg/day, alone
       or in combination with zidovudine, 200 mg q8h. Nevirapine was well
       tolerated in the doses tested. Mean steady-state trough levels were
       0.23, 1.1, and 1.9 micrograms/ml for the 12.5, 50, and 200 mg/day doses,
       respectively. Early suppression of p24 antigen levels and increase in
       CD4+ cell count were reversed following rapid emergence of virus less
       susceptible to nevirapine. Resistant strains were isolated from all
       participants by 8 weeks. Nevertheless, reduction of p24 antigen levels
       to < 50% of baseline values persisted for 12 weeks or more in four of
       seven persons who received 200 mg nevirapine/day in combination with
       zidovudine: these individuals had been antigenemic on long-term
       zidovudine therapy. This study demonstrates a direct relationship
       between drug resistance and effects on surrogate markers in HIV-1
       infection.
 DE    Adult  Antiviral Agents/*THERAPEUTIC USE  CD4 Lymphocyte Count
       Dose-Response Relationship, Drug  Drug Therapy, Combination  Female
       Human  HIV Core Protein p24/BLOOD  HIV Infections/BLOOD/*DRUG THERAPY
       HIV-1/*DRUG EFFECTS  Male  Middle Age  Pyridines/ADVERSE
       EFFECTS/PHARMACOKINETICS/*THERAPEUTIC USE  Reverse
       Transcriptase/ANTAGONISTS & INHIB  Support, Non-U.S. Gov't  Support,
       U.S. Gov't, Non-P.H.S.  Support, U.S. Gov't, P.H.S.  United States
       Zidovudine/*THERAPEUTIC USE  CLINICAL TRIAL  CLINICAL TRIAL, PHASE I
       CLINICAL TRIAL, PHASE II  JOURNAL ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).