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M Floridia

Publications and source records attributed to M Floridia.

26 records · Page 2Linked to original sources
PubMed1992

Survival of zidovudine-treated patients with AIDS compared with that of contemporary untreated patients. Italian Zidovudine Evaluation Group.

OBJECTIVE: To assess the long-term effectiveness of zidovudine (AZT) in patients with acquired immunodeficiency syndrome (AIDS). This assessment has never been adequately done because controlled clinical trials were stopped early and survival comparisons were made with historical controls. DESIGN: Nonrandomized contemporary observational study of patients treated and not treated with zidovudine. SETTING: Twenty-three AIDS treatment centers throughout Italy that reported cases to the National Registry of AIDS Cases between July 1987 and March 1988. PATIENTS: One hundred fifty-nine zidovudine-treated and 112 untreated patients with AIDS, the majority of whom had acquired human immunodeficiency virus (HIV) infection through intravenous drug use. OUTCOME MEASURES: Median survival and 1- and 2-year survival for treated and untreated groups, as estimated using the Kaplan-Meier method. Cox proportional hazards regression analysis was also used to identify independent predictors of survival among the variables studied. RESULTS: Patients were similar with respect to CD4/CD8 ratio, age, sex, clinical and immunological status at diagnosis, and source of HIV infection. After 24 months, survival was 45.9% (95% confidence interval [CI], 36.1% to 55.7%) in the treated group and 20.5% (95% CI, 12.6% to 28.3%) in the untreated group, with median survival of 21.2 and 9.6 months, respectively. CONCLUSIONS: Possible biases of this study include imperfect matching for clinical status and better overall medical care of treated patients. Nevertheless, we believe that the observed differences in survival were primarily due to zidovudine treatment.

Acquired Immunodeficiency Syndrome↗
PubMed1992

The effects of AZT and DDI on pre- and postimplantation mammalian embryos: an in vivo and in vitro study.

This study reports the effects of the nucleoside analogs dideoxyinosine (DDI) and 3'-azido-3'-deoxythymidine (AZT) on mammalian embryonic development. When administered to pregnant mice (at concentrations ranging from 10 to 300 mg/kg/day), through all or part of gestation, AZT and DDI did not result in any visible effect on mouse embryos nor did they cause any obvious malformation or defect at birth or during postnatal growth. Similarly, when embryonic or fetal mouse or human cells (from brain, limb buds, or different organ rudiments) were exposed to AZT or DDI in vitro, cytotoxicity was observed only in the mM range, with AZT showing slightly higher cytotoxicity and brain cells appearing slightly more sensitive to both nucleosides. However, even in cultures treated with very high concentrations of AZT or DDI, the reduction in the number of terminally differentiated skeletal myotubes, cardiocytes, neurons, and chondrocytes was similar to the reduction in the total number of cells, indicating that AZT and DDI did not selectively inhibit differentiation of any of the above-mentioned cell types. Finally, preimplantation mouse embryos (at the 2-cell or 4-cell stage), treated in vitro with micromolar concentrations of AZT, were arrested at the 4-cell stage. DDI or other nucleoside analogs tested did not have this effect.

Animals↗
PubMedDate not supplied

Hospitalizations and costs of treatment for protease inhibitor-based regimens in patients with very advanced HIV-infection (CD4 < 50/mm(3)).

PURPOSE: To describe the cost of hospitalization and treatment in patients with very advanced disease who tart different regimens based on a protease inhibitor (PI). METHOD: An observational retrospective analysis was performed on data from a 48-week randomized, multicenter study. Analysis was based on a subgroup of centers that were geographically defined. Costs of ordinary hospital admissions and of antiretroviral treatment were considered. Incidence of hospitalization and number of days free from hospitalization during the period of observation were calculated. Cost and hospitalization measures were compared among patients receiving three different therapeutic regimens: only PI, PI plus one nucleoside, or PI plus two nucleosides. A multivariate analysis was used to assess cost differences, controlling for variables potentially able to influence outcome. RESULTS: Overall, among 166 patients starting PI (PI plus two nucleosides, 71;PI plus one nucleoside, 65; only PI, 30), 162 ordinary hospital admissions were observed during about 1 year of follow-up. Monthly rates of admission per person and incidence of first hospitalization on 100 person-months showed a clear inverse relationship with the number of drugs comprising the baseline treatment regimen, with the lower rates for the triple therapy group (0.06 and 3.9, respectively), intermediate values for the dual therapy group (0.10 and 8.1, respectively), and higher rates for the PI monotherapy group (0.15 and 13.7, respectively). The average number of days free from hospitalization per month was 29.5 in the triple therapy group, 28.6 in the dual therapy group, and 27.9 in the monotherapy group. The results of cost analysis showed, despite higher cost of antiretroviral treatment, that global costs were progressively lower using regimens of increasing potency: Compared to PI monotherapy, global cost (costs of antiretroviral treatment and of hospitalizations combined) per month per patient was 31.9% lower for the triple therapy group and 19.3% lower for the dual therapy. Global cost for the triple therapy was 15.7% lower compared to global cost for dual therapy. After adjustment for CD4 count, AIDS status, and Karnofsky score, both hospitalization costs and global costs were significantly lower for triple therapy compared to monotherapy (p =.002 and.039, respectively). CONCLUSION: In advanced and nucleoside-experienced patients, PI-containing regimens have a differential impact according to the overall strength of the regimen, with the best effects on both hospitalizations and treatment costs obtained using PI within potent combination regimens.

Adult↗
PubMedDate not supplied

Lipid profile during pregnancy in HIV-infected women.

PURPOSE: We investigated the evolution of serum lipid levels in HIV-infected pregnant women and the potential effect of antiretroviral treatment during pregnancy using data from a national surveillance study. METHOD: Fasting lipid measurements collected during routine care in pregnancy were used, analyzing longitudinal changes and differences in lipid values at each trimester by protease inhibitors (PIs) and stavudine use. Multivariate analyses were used to control for simultaneous factors potentially leading to hyperlipidemia. Study population included 248 women. RESULTS: Lipid values increased progressively and significantly during pregnancy: mean increases between the first and third trimesters were 141.6 mg/dL for triglycerides (p < .001), 60.8 mg/dL for total cholesterol (p < .001), 13.7 mg/dL for HDL cholesterol (p < .001), and 17.8 mg/dL for LDL cholesterol (p = .001). At all trimesters, women on PIs had significantly higher triglyceride values compared to women not on PIs. The effect of PIs on cholesterol levels was less consistent. Stavudine showed a dyslipidemic effect at first trimester only. Multivariate analyses confirmed these observations and suggested a potential role of other cofactors in the development of hyperlipidemia during pregnancy. CONCLUSION: The changes observed point to the need to further explore the causes and the clinical correlates of hyperlipidemia during pregnancy in women with HIV.

Adult↗
PubMedDate not supplied

[Decrease in notifications of AIDS dementia complex in 1989-1990 in Italy: possible role of the early treatment with zidovudine].

We evaluated the incidence of AIDS dementia complex (ADC) in groups of patients who acquired infection through different risk behaviours, and attempted to evaluate the possible role of zidovudine (AZT) treatment in preventing or delaying the onset of ADC. The Italian National AIDS Registry was used to study patients with AIDS for whom ADC was reported as an index disease. Relative risk of presenting ADC between different patient categories has been determined. Logistic regression was used to analyse temporal trends in the proportion of AIDS cases presenting with ADC. Of the 6466 cases reported between August '87 and August '90, ADC was seen in 640 (9.9%). I. V. drug addicts had twice the risk (estimated odds ratio: 1.9; 95% confidence interval: 1.5-2.6, p less than 0.001), compared to homo/bisexuals, of presenting with ADC. There is significant evidence (p less than 0.0001) that after a progressive increase in the period '87-'89, it began a definite decrease in the monthly proportion of ADC cases, starting August '89. AZT was introduced in Italy in July 1987 for patients with AIDS or advanced ARC. The incidence of AIDS dementia complex at the moment of AIDS diagnosis in our population of patients, began to decline 24 months after the introduction of systematic AZT treatment in Italy. This could have been due to inhibition of HIV replication in the Central Nervous System among patients who initiated AZT-treatment before developing full-blown AIDS.

AIDS Dementia Complex↗