Document 2800
 DOCN  M94A2800
 TI    Zidovudine-thymostimulin association in the treatment of CDC2 and CDC3
       HIV-positive patients: the second stage of TP1-AZT Multicenter Study
       (TAMS-2).
 DT    9412
 AU    Barbaro G; Barbarini G; De Rosa F; Institute of Infectious Diseases,
       University La Sapienza, Rome,; Italy.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):221 (abstract no. PB0313). Unique
       Identifier : AIDSLINE ICA10/94369775
 AB    OBJECTIVE. Aim of TAMS-2 has been to define the therapeutic efficacy and
       the clinical and immunological effects of the association of low dose
       zidovudine (AZT) and Thymostimulin (TP1) on HIV-positive patients
       belonging to CDC groups 2 and 3. METHODS. The study has considered 248
       HIV-positive patients, divided in 2 groups: group A (123 CDC group 2
       pts) and group B (125 CDC group 3 pts). Each group has been randomized
       in 2 subgroups according to pharmacological therapy: subgroups A1 (n =
       62) and B1 (n = 61) have been treated with AZT (500 mg/daily), while
       subgroups A2 (n = 63) and B2 (n = 62) have been treated with AZT+TP1 (70
       mg i.m. x 3/weekly). Clinical and laboratory parameters have been
       checked every 3 months up to the end of follow-up (17 + 3 months).
       RESULTS. 1)--In group A a significant increase of T cells subset CD4+
       has been observed in AZT+TP1 treated group, with a difference
       statistically significant in comparison with both the pretreatment
       values (+7.6%; p < 0.001) and AZT treated group (+13.5%; p < 0.001). At
       the end of follow-up a significant difference in White Blood Cells (WBC)
       count between groups A1 and A2 has been noticed [+15% in group A2 (p <
       0.001 vs basal values), with a reduction of 28% in group A1 (p < 0.001
       vs basal values and p < 0.001 vs group A2)]. The only opportunistic
       infection observed in the patients of group A was oral candidiasis. Oral
       candidiasis was observed in 6 patients (9.6%) of group A1 and in 1
       patient (1.5%) of group A2 (p < 0.01). No patient of 2 subgroups of
       group A presented evolution to AIDS according to CDC criteria. 2)--In
       group B a significant increase of T cells subset CD4+ has been observed
       in AZT+TP1 treated group with a difference statistically significant in
       comparison with both the pretreatment values (+9.3%; p < 0.001) and AZT
       treated group (+13.7%; p < 0.001). In AZT treated group a significant
       myelodepression has been observed in comparison with the pretreatment
       values. At the end of follow-up a difference has been observed between
       groups B1 and B2 in the values of blood cells count, with a significant
       increase in AZT+TP1 treated group [RBC: +8.1% (p < 0.001); WBC: +15% (p
       < 0.001); PTL: +30% (p < 0.001)]. Opportunistic infections were observed
       in 14 patients (22.9%) of group B1 and in 9 patients (14.5%) of group B2
       [relative risk ratio: 0.64 (95% C.I.: 0.27-0.82); p < 0.001)].
       Progression to AIDS was observed in 5 patients (8.2%) of group B1 and in
       2 patients (3.2%) of groups B2 [relative risk ratio: 0.40 (95% C.I.:
       0.22-0.70); p < 0.05)]. CONCLUSIONS. These results suggest that AZT+TP1
       association, may be useful especially in the early stages of HIV disease
       and, particularly, in HIV-positive patients with a value of T cells
       subset CD4+ > or = 400/mm3 and < 600/mm3, with a significant improvement
       of cell-mediated immunity parameters and reduction of the incidence of
       opportunistic infections. Nevertheless, in more advanced stages of HIV
       disease this association may be indicated for the positive action on the
       immunological and hematological parameters contrasting the
       myelodepressive effect of a long term treatment with AZT.
 DE    Adjuvants, Immunologic/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE
       AIDS-Related Opportunistic Infections/EPIDEMIOLOGY/PREVENTION &  CONTROL
       Bone Marrow Diseases/CHEMICALLY INDUCED  Candidiasis,
       Oral/EPIDEMIOLOGY/PREVENTION & CONTROL  Combined Modality Therapy
       Comparative Study  Human  HIV Infections/DRUG THERAPY/*THERAPY
       Incidence  Leukocyte Count  Risk  Thymus Extracts/ADMINISTRATION &
       DOSAGE/*THERAPEUTIC USE  Treatment Outcome  T4 Lymphocytes
       Zidovudine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC  USE
       CLINICAL TRIAL  MEETING ABSTRACT  MULTICENTER STUDY  RANDOMIZED
       CONTROLLED TRIAL

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