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M9550190.TXT
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1995-03-04
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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).