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1996-02-26
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Document 0283
DOCN M9620283
TI Treatment with lamivudine, zidovudine, or both in HIV-positive patients
with 200 to 500 CD4+ cells per cubic millimeter. North American HIV
Working Party [see comments]
DT 9602
AU Eron JJ; Benoit SL; Jemsek J; MacArthur RD; Santana J; Quinn JB;
Kuritzkes DR; Fallon MA; Rubin M; University of North Carolina at Chapel
Hill 27599-7030, USA.
SO N Engl J Med. 1995 Dec 21;333(25):1662-9. Unique Identifier : AIDSLINE
MED/96083638
CM Comment in: N Engl J Med 1995 Dec 21;333(25):1704-5
AB BACKGROUND. The reverse-transcriptase inhibitor lamivudine has in vitro
synergy with zidovudine against the human immunodeficiency virus (HIV).
We studied the activity and safety of lamivudine plus zidovudine as
compared with either drug alone as treatment for patients with HIV
infection, most of whom had not previously received zidovudine. METHODS.
Three hundred sixty-six patients with 200 to 500 CD4+ cells per cubic
millimeter who had received zidovudine for four weeks or less were
randomly assigned to treatment with one of four regimens: 300 mg of
lamivudine every 12 hours; 200 mg of zidovudine every 8 hours; 150 mg of
lamivudine every 12 hours plus zidovudine; or 300 mg of lamivudine every
12 hours plus zidovudine. The study was double-blind and lasted 24
weeks, with an extension phase for another 28 weeks. RESULTS. Over the
24-week period, the low-dose and high-dose regimens combining lamivudine
and zidovudine were associated with greater increases in the CD4+ cell
count (P = 0.002 and P = 0.015, respectively) and the percentage of CD4+
cells (P < 0.001 for both) and with greater decreases in plasma levels
of HIV-1 RNA (P < 0.001 for both) than was treatment with zidovudine
alone. Combination therapy was also more effective than lamivudine alone
in lowering plasma HIV-1 RNA levels and increasing the percentage of
CD4+ cells (P < 0.001 for all comparisons), and these advantages
persisted through 52 weeks. Adverse events were no more frequent with
combination therapy than with zidovudine alone. CONCLUSIONS. In
HIV-infected patients with little or no prior antiretroviral therapy,
treatment with a combination of lamivudine and zidovudine is well
tolerated over a one-year period and produces more improvement in
immunologic and virologic measures than does treatment with either agent
alone.
DE Adult Antiviral Agents/ADVERSE EFFECTS/*THERAPEUTIC USE Comparative
Study CD4 Lymphocyte Count/DRUG EFFECTS Double-Blind Method Drug
Therapy, Combination Female Human HIV Infections/*DRUG
THERAPY/IMMUNOLOGY *HIV-1/GENETICS Male Reverse Transcriptase
Inhibitors/ADVERSE EFFECTS/*THERAPEUTIC USE RNA, Viral/BLOOD Support,
Non-U.S. Gov't Treatment Outcome Zalcitabine/*ANALOGS &
DERIVATIVES/ADVERSE EFFECTS/THERAPEUTIC USE Zidovudine/ADVERSE
EFFECTS/*THERAPEUTIC USE CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER
STUDY RANDOMIZED CONTROLLED TRIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).