Document 0772
 DOCN  M95A0772
 TI    A controlled trial of zidovudine in primary human immunodeficiency virus
       infection [see comments]
 DT    9510
 AU    Kinloch-De Loes S; Hirschel BJ; Hoen B; Cooper DA; Tindall B; Carr A;
       Saurat JH; Clumeck N; Lazzarin A; Mathiesen L; et al; Central Laboratory
       of Virology, Geneva University Hospital,; Switzerland.
 SO    N Engl J Med. 1995 Aug 17;333(7):408-13. Unique Identifier : AIDSLINE
       MED/95342191
 CM    Comment in: N Engl J Med 1995 Aug 17;333(7):450-1
 AB    BACKGROUND. It is possible that antiretroviral treatment given early
       during primary infection with the human immunodeficiency virus (HIV) may
       reduce acute symptoms, help preserve immune function, and improve the
       long-term prognosis. METHODS. To assess the effect of early antiviral
       treatment, we conducted a multicenter, double-blind, placebo-controlled
       trial in which 77 patients with primary HIV infection were randomly
       assigned to receive either zidovudine (250 mg twice daily; n = 39) or
       placebo (n = 38) for six months. RESULTS. The mean time from the onset
       of symptoms until enrollment in the study was 25.1 days. Among the 43
       patients who were still symptomatic at the time of enrollment, there was
       no appreciable difference in the mean (+/- SE) duration of the
       retroviral syndrome between the zidovudine group (15.0 +/- 4.1 days) and
       the placebo group (15.8 +/- 3.6 days). During a mean follow-up period of
       15 months, minor opportunistic infections developed in eight patients:
       oral candidiasis in four, herpes zoster in two, and oral hairy
       leukoplakia in two. Disease progression was significantly less frequent
       in the zidovudine group (one opportunistic infection) than in the
       placebo group (seven opportunistic infections; P = 0.009 by the log-rank
       test). After adjustment for the base-line CD4 cell count, the patients
       treated with zidovudine had an average gain of 8.9 CD4 cells per cubic
       millimeter per month (95 percent confidence interval, -1.4 to 19.1)
       during the first six months of the study, whereas those receiving
       placebo had an average loss of 12.0 CD4 cells per cubic millimeter per
       month (95 percent confidence interval, 5.2 to 18.7), for a between-group
       difference of 20.9 CD4 cells per cubic millimeter per month (95 percent
       confidence interval, 8.5 to 33.2; P = 0.001). CONCLUSIONS.
       Antiretroviral therapy administered during primary HIV infection may
       improve the subsequent clinical course and increase the CD4 cell count.
 DE    Adult  AIDS-Related Opportunistic Infections/EPIDEMIOLOGY/PREVENTION &
       CONTROL  CD4 Lymphocyte Count/DRUG EFFECTS  Disease Progression
       Disease-Free Survival  Double-Blind Method  Female  Follow-Up Studies
       Human  HIV Infections/*DRUG THERAPY/IMMUNOLOGY/VIROLOGY
       HIV-1/GENETICS/ISOLATION & PURIF  Male  Middle Age  RNA, Viral/ANALYSIS
       Support, Non-U.S. Gov't  Time Factors  Zidovudine/ADMINISTRATION &
       DOSAGE/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).