Document 2849
 DOCN  M94A2849
 TI    Preliminary results of a phase II study on the efficacy and tolerability
       of AZT plus alfa-interferon in patients with asymptomatic HIV infection
       and CD4 between 200 and 500.
 DT    9412
 AU    Tavio M; Colomba A; Izzo E; Pintus A; Puppoa F; Serraino D; Traina C;
       Tirelli U; Centro di Riferimento Oncologico, Aviano, Italy.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):210 (abstract no. PB0270). Unique
       Identifier : AIDSLINE ICA10/94369726
 AB    OBJECTIVE: To evaluate the efficacy and the tolerability of AZT plus
       alfa-Interferon. METHODS: Phase-II study including patients with HIV
       infection and: CDC group 2 or 3, CD4 count between 200 and 500,
       Karnofsky index > or = 60. The therapeutic regimen consisted of 250 mg
       of AZT per os two times per day plus three MU of alfa-Interferon
       (WELLFERON) subcutaneously three times per week for one year. Efficacy
       was assessed by measuring the level of the p24 antigen and by CD4 count
       and tolerability by registering side effects. RESULTS: Between July 1991
       and March 1993, 77 patients were enrolled in the study, with a median
       time of follow-up of 6 months (range: 1-20 months). At enrollment, the
       median number of CD4 was 330 (range:200-500), after three months it was
       390 and after 9 months 410. Levels of haemoglobin, platelets, SGOT, SGPT
       and creatinine were normal at enrollment and during the follow-up
       period. Nineteen patients were positive for p24 antigenemia, and 10 of
       them became negative during the follow-up. The treatment was interrupted
       by 16 patients (6 were lost to follow-up; 5 had serious side effects; 2
       had a severe anaemia; 1 had a severe depression and 1 died).
       CONCLUSIONS: These preliminary results indicate that AZT plus
       alfa-Interferon is a feasible regimen and that it may improve the
       treatment of HIV infection. They also further stress the need of
       controlled clinical trials in this field.
 DE    Biological Response Modifiers/*THERAPEUTIC USE  Combined Modality
       Therapy  Human  HIV Core Protein p24/BLOOD  HIV Infections/DRUG
       THERAPY/*THERAPY  Interferon-alpha/*THERAPEUTIC USE  Leukocyte Count
       Safety  Treatment Outcome  T4 Lymphocytes  Zidovudine/ADVERSE
       EFFECTS/*THERAPEUTIC USE  CLINICAL TRIAL  CLINICAL TRIAL, PHASE II
       MEETING ABSTRACT

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