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1994-10-25
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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).