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1994-10-25
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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
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).