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1.
Braz. j. biol ; 78(4): 750-754, Nov. 2018. tab
Article in English | LILACS | ID: biblio-951601

ABSTRACT

Abstract Forty five specimens representing nine species of reptile (Salvator merianae, Enyalius bilineatus, Amphisbaena alba, Xenopholis undulatus, Chironius fuscus, Helicops angulatus, Chironius flavolineatus, Erythrolamprus viridis and Crotalus durissus) collected in five Brazilian states were examined for helminths. Twelve helminth species were found as follow: nine Nematoda (Physaloptera tupinambae, Strongyluris oscari, Paracapillaria sp., Dracunculus brasiliensis, Physaloptera liophis, Serpentirhabias sp. 1, Serpentirhabias sp. 2, Serpentirhabias sp. 3 and Aplectana sp.), one Cestoda (Semenoviella amphisbaenia), one Trematoda (Paracotyletrema sp.), and one Acantocephala (Centrorhynchus sp.). Ten new host records and seven new locality records were reported.


Resumo Quarenta e cinco espécimes que representa nove espécies de répteis (Salvator merianae, Enyalius bilineatus, Amphisbaena alba, Xenopholis undulatus, Chironius fuscus, Helicops angulatus, Chironius flavolineatus, Erythrolamprus viridis e Crotalus durissus) coletados em cinco estados brasileiros foram examinados para helmintos. Foram encontrados doze espécies de helmintos sendo: nove Nematoda (Physaloptera tupinambae, Strongyluris oscari, Paracapillaria sp., Dracunculus brasiliensis, Physaloptera liophis, Serpentirhabias sp. 1, Serpentirhabias sp. 2, Serpentirhabias sp. 3 e Aplectana sp.), um Cestoda (Semenoviella amphisbaenia), um Trematoda (Paracotyletrema sp.) e um Acantocephala (Centrorhynchus sp.). Dez novos registros de hospedeiros e sete novos registros de localidade foram relatados.


Subject(s)
Animals , Reptiles/parasitology , Helminthiasis, Animal/epidemiology , Helminths/classification , Brazil
2.
Braz J Biol ; 78(4): 750-754, 2018 Nov.
Article in English | MEDLINE | ID: mdl-29489929

ABSTRACT

Forty five specimens representing nine species of reptile (Salvator merianae, Enyalius bilineatus, Amphisbaena alba, Xenopholis undulatus, Chironius fuscus, Helicops angulatus, Chironius flavolineatus, Erythrolamprus viridis and Crotalus durissus) collected in five Brazilian states were examined for helminths. Twelve helminth species were found as follow: nine Nematoda (Physaloptera tupinambae, Strongyluris oscari, Paracapillaria sp., Dracunculus brasiliensis, Physaloptera liophis, Serpentirhabias sp. 1, Serpentirhabias sp. 2, Serpentirhabias sp. 3 and Aplectana sp.), one Cestoda (Semenoviella amphisbaenia), one Trematoda (Paracotyletrema sp.), and one Acantocephala (Centrorhynchus sp.). Ten new host records and seven new locality records were reported.


Subject(s)
Helminthiasis, Animal/epidemiology , Helminths/classification , Reptiles/parasitology , Animals , Brazil
3.
Article in English | LILACS-Express | LILACS, VETINDEX | ID: biblio-1467148

ABSTRACT

Abstract Forty five specimens representing nine species of reptile (Salvator merianae, Enyalius bilineatus, Amphisbaena alba, Xenopholis undulatus, Chironius fuscus, Helicops angulatus, Chironius flavolineatus, Erythrolamprus viridis and Crotalus durissus) collected in five Brazilian states were examined for helminths. Twelve helminth species were found as follow: nine Nematoda (Physaloptera tupinambae, Strongyluris oscari, Paracapillaria sp., Dracunculus brasiliensis, Physaloptera liophis, Serpentirhabias sp. 1, Serpentirhabias sp. 2, Serpentirhabias sp. 3 and Aplectana sp.), one Cestoda (Semenoviella amphisbaenia), one Trematoda (Paracotyletrema sp.), and one Acantocephala (Centrorhynchus sp.). Ten new host records and seven new locality records were reported.


Resumo Quarenta e cinco espécimes que representa nove espécies de répteis (Salvator merianae, Enyalius bilineatus, Amphisbaena alba, Xenopholis undulatus, Chironius fuscus, Helicops angulatus, Chironius flavolineatus, Erythrolamprus viridis e Crotalus durissus) coletados em cinco estados brasileiros foram examinados para helmintos. Foram encontrados doze espécies de helmintos sendo: nove Nematoda (Physaloptera tupinambae, Strongyluris oscari, Paracapillaria sp., Dracunculus brasiliensis, Physaloptera liophis, Serpentirhabias sp. 1, Serpentirhabias sp. 2, Serpentirhabias sp. 3 e Aplectana sp.), um Cestoda (Semenoviella amphisbaenia), um Trematoda (Paracotyletrema sp.) e um Acantocephala (Centrorhynchus sp.). Dez novos registros de hospedeiros e sete novos registros de localidade foram relatados.

4.
Biomed Pharmacother ; 69: 233-6, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25661363

ABSTRACT

The relationship between hepatic tolerance and hepatitis C virus (HCV) co-infection has not been extensively studied in clinical practice. We assessed the efficacy and safety of raltegravir-based therapy in an Italian cohort of HIV/HCV co-infected patients. One hundred and forty patients with HIV/HCV co-infection initiating raltegravir from SCOLTA project (Surveillance Cohort Long-Term Toxicity Antiretrovirals) were examined. Of them, 43 were women, with mean age of 45.4±6.4years; 65 (46%) had undetectable HIV-RNA<50copies/mL and 75 (54%) HIV-RNA≥50copies/mL. According to CDC classification, 49 (35%) were in stage C. Based on Fib4 score at the time of starting raltegravir, patients were classified in class I in 41 cases, class II in 68 and in class III in 31 cases. Globally, the Fib4 score slightly decreased during 24months follow-up, from 2.2 to a value of 1.8. Hepatic adverse events of any grade were observed in 67 patients, of which only 2 cases (3%) had severe liver toxicity (grade 3-4). Only one patient had to discontinue the therapy because of adverse events. According to univariate analysis, being in CDC stage C represented a risk for the development of liver toxicity, with a hazard ratio (HR) of 2.27 (95% CI 1.06-4.84, P=0.033). None of the other variables considered (age, sex, years since detection of HIV and HCV-RNA detectable, years of previous HIV therapy, concomitant therapy with PI or NRTI, CD4+ cell count, Fib4, and transaminases level at baseline) resulted statistically correlated to the outcome. In conclusion, raltegravir-based regimens can be safely used in HCV infected patients; in this study, the hepatic toxicity has been found to be more frequent in patients with an advanced HIV disease (CDC stage C), independently of HIV-RNA suppression at raltegravir initiation.


Subject(s)
Coinfection/drug therapy , Coinfection/virology , HIV Infections/drug therapy , HIV Infections/virology , Hepatitis C/drug therapy , Hepatitis C/virology , Pyrrolidinones/therapeutic use , Alanine Transaminase/metabolism , Aspartate Aminotransferases/metabolism , Cohort Studies , Demography , Female , Follow-Up Studies , Humans , Liver/pathology , Male , Middle Aged , RNA, Viral/metabolism , Raltegravir Potassium
5.
Biomed Pharmacother ; 68(3): 385-90, 2014 Apr.
Article in English | MEDLINE | ID: mdl-24613008

ABSTRACT

OBJECTIVES: Evaluate gender differences with regard to baseline characteristics and outcome of therapy in cohorts of the SCOLTA (surveillance cohort long-term toxicity of antiretrovirals) project. METHODS: The SCOLTA project is an active pharmacovigilance system for new antiretroviral drugs. Since 2002, patients were enrolled in nine cohorts (lopinavir, tenofovir, atazanavir, fosamprenavir, enfuvirtide, tipranavir, darunavir, raltegravir and maraviroc). RESULTS: Two thousand one hundred and fifty-four patients were included in 5 PI cohorts; 607 (28.2%) were female. Women were younger and less frequently HCV-coinfected than men. At study entry, they were less frequently in CDC stage C, but CD4+ cells/mm(3) and detectable HIV-RNA were not different by gender. Women had triglycerides alterations less frequently than men, but showed a higher proportion of low HDL-cholesterol. Women were protected from incident grade 2-4 triglycerides increase (odds ratio=0.39, 95% confidence interval 0.18-0.88; P=0.02). Mean CD4+ cell count increased in both men and women; despite a non-significantly lower initial CD4+ level, women had a better immunological recovery. Women discontinued PI treatment for adverse events and their own will more frequently. CONCLUSIONS: In these cohorts, gender distribution mirrored the Italian HIV population. Women were younger than men when they started their first ARV therapy and when they entered our cohorts. On the same treatment, they had a better immune response, though no significant difference emerged on virologic control and treatment durability. As compared to men, women appeared at lower risk of hypertriglyceridaemia. They stopped PI-based treatment of their own will more frequently than men, suggesting the need for a focused effort on adherence.


Subject(s)
Anti-HIV Agents/adverse effects , Anti-HIV Agents/therapeutic use , Drug-Related Side Effects and Adverse Reactions/etiology , HIV Infections/drug therapy , Sex Characteristics , Anti-HIV Agents/administration & dosage , Antiretroviral Therapy, Highly Active , CD4 Lymphocyte Count , Cohort Studies , Databases, Factual , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/immunology , Female , HIV Infections/epidemiology , HIV Infections/immunology , HIV Infections/metabolism , Humans , Italy/epidemiology , Logistic Models , Male , Medication Adherence , Pharmacovigilance , Triglycerides/blood
7.
Mucosal Immunol ; 4(5): 554-63, 2011 Sep.
Article in English | MEDLINE | ID: mdl-21525866

ABSTRACT

Intestinal mucosal immune system is an early target for human immunodeficiency virus type 1 (HIV-1) infection, resulting in CD4(+) T-cell depletion, deterioration of gut lining, and fecal microbiota composition. We evaluated the effects of a prebiotic oligosaccharide mixture in highly active antiretroviral therapy (HAART)-naive HIV-1-infected adults. In a pilot double-blind, randomized, placebo-controlled study, 57 HAART-naive HIV-1-infected patients received a unique oligosaccharide mixture (15 or 30 g short chain galactooligosaccharides/long chain fructooligosaccharides/pectin hydrolysate-derived acidic oligosaccharides (scGOS/lcFOS/pAOS) daily) or a placebo for 12 weeks. Microbiota composition improved significantly with increased bifidobacteria, decreased Clostridium coccoides/Eubacterium rectale cluster, and decreased pathogenic Clostridium lituseburense/Clostridium histolyticum group levels upon prebiotic supplementation. In addition, a reduction of soluble CD14 (sCD14), activated CD4(+)/CD25(+) T cells, and significantly increased natural killer (NK) cell activity when compared with control group were seen in the treatment group. The results of this pilot trial highly significantly show that dietary supplementation with a prebiotic oligosaccharide mixture results in improvement of the gut microbiota composition, reduction of sCD14, CD4(+) T-cell activation (CD25), and improved NK cell activity in HAART-naive HIV-infected individuals.


Subject(s)
HIV Infections/immunology , HIV/immunology , Intestines/immunology , Intestines/microbiology , Metagenome , Prebiotics , Adult , Antiretroviral Therapy, Highly Active , CD4-Positive T-Lymphocytes/immunology , Female , HIV Infections/virology , Humans , Immunophenotyping , Killer Cells, Natural/immunology , Lipopolysaccharide Receptors/metabolism , Lipopolysaccharides/metabolism , Lymphocyte Activation/immunology , Male , Middle Aged , Prebiotics/adverse effects
9.
Int J STD AIDS ; 21(4): 267-72, 2010 Apr.
Article in English | MEDLINE | ID: mdl-20378899

ABSTRACT

The aim of the study was to evaluate the cardiovascular risk factors associated with subclinical carotid atherosclerosis in antiretroviral therapy-naïve HIV-infected patients. The HERMES (HIV Exposure and Risk of Metabolic Syndrome) study enrolled therapy-naïve patients attending hospitals in the Italian coordination group for the study of allergies and HIV infection (CISAI [Coordinamento Italiano per lo Studio Allergia e Infezione da HIV]) in 2007. It was designed to identify metabolic syndrome (MS) and cardiovascular risk factors. The present analysis is a nested cross-sectional study with a subset of patients examined by carotid ultrasonography. Consecutive antiretroviral therapy-naïve HIV patients attending the facilities involved in the CISAI were included. Their 10-year probability of cardiovascular events was calculated using the Framingham Risk Score (FRS) and three other cardiovascular algorithms (the Global Framingham Risk Score - GFRS, 'Progetto Cuore' and 'SCORE'). Vascular age was estimated using a new model derived from GFRS and was compared with chronological age. The diagnosis of MS was based on the National Cholesterol Education Programme and International Diabetes Federation (IDF) definitions. Subclinical atherosclerosis was determined as ultrasound carotid intima-media thickness >0.9 mm. Out of 140 patients enrolled in the HERMES study by the four centres participating in the nested study, a total of 72 (51.4%) subjects, with no overt cardiovascular disease, were examined using carotid ultrasonography. The median age was 40 years, 79.2% men. The vascular age was 7.6 years higher than the chronological age. The factors associated with subclinical atherosclerosis were age (P < 0.0001), vascular age (P = 0.0002), body mass index (P = 0.003), waist circumference (P = 0.0002), MS (IDF definition, P = 0.004) and all the cardiovascular (CV) models (FRS, P = 0.01, GFRS, P = 0.002, Progetto Cuore, P = 0.018, SCORE, P = 0.03). Independent of other significant factors, waist circumference was significantly associated with pathological results (P = 0.007). The GFRS (area under the receiver-operating characteristic curves, 0.78; P < 0.001) had slightly better predictive accuracy than the other three CV models (FRS, areas under the curve [AUC] = 0.71, P = 0.003; Progetto Cuore, AUC = 0.74, P = 0.0005; SCORE, AUC = 0.77, P < 0.0001); 55% of patients at intermediate risk (6-20%) had subclinical carotid lesions. Subclinical carotid lesions had a highly significant direct association with all the CV risk predictors. The GFRS and vascular age were highly predictive. We recommend a carotid ultrasonographic examination at least among HIV patients with GFRS > or =6% or with an elevated waist circumference.


Subject(s)
Atherosclerosis/epidemiology , Carotid Artery Diseases/epidemiology , HIV Infections/complications , Adult , Atherosclerosis/diagnostic imaging , Atherosclerosis/virology , Carotid Artery Diseases/diagnostic imaging , Carotid Artery Diseases/virology , Cross-Sectional Studies , Female , Humans , Italy , Male , Metabolic Syndrome/epidemiology , Metabolic Syndrome/virology , Middle Aged , ROC Curve , Risk Assessment , Risk Factors , Tunica Intima/diagnostic imaging , Tunica Media/diagnostic imaging , Ultrasonography
10.
HIV Med ; 11(1): 40-5, 2010 Jan.
Article in English | MEDLINE | ID: mdl-19686438

ABSTRACT

BACKGROUND: Atazanavir (ATV) has demonstrated high efficacy and safety in both treatment-naïve and treatment-experienced patients. Some comparative data are available on the durability of ritonavir-boosted (ATV/r) and unboosted formulations, but there are no data on clinicians' motivations for choosing one or another in everyday practice. The aim of this study was to evaluate the long-term efficacy of boosted and unboosted ATV in a cohort of treatment-experienced patients. METHODS: All patients included in the study were enrolled in an observational cohort within the Surveillance Cohort Long-Term Toxicity Antiretrovirals (SCOLTA) Project. Data on CD4 cell count, HIV viral load, metabolic parameters and adverse events of grade 3-4 are collected through an on-line system every six months. The duration of treatment with ATV was evaluated using the Kaplan-Meier curve and boosted and unboosted regimens were compared using the log-rank test. RESULTS: A total of 509 patients starting ATV as a component of their antiretroviral therapy were enrolled in the SCOLTA Project at the time of the study. Boosted ATV was received by 379 patients (74.5%) while 130 (25.5%) were treated with the unboosted formulation. The last therapeutic regimen did not influence the choice of ATV formulation. The mean observational time was 23.9 months. At the end of follow-up, 58.5% of patients on unboosted ATV and 58.1% of patients on ATV/r continued the treatment and no statistically significant differences were observed for ATV durability between the formulations or among the single causes of therapy interruption. CONCLUSIONS: Our results suggest that, in unselected clinical settings, ATV-containing antiretroviral therapy is durable and safe in both its formulations.


Subject(s)
Anti-HIV Agents/therapeutic use , HIV Infections/drug therapy , HIV Protease Inhibitors/therapeutic use , Oligopeptides/therapeutic use , Pyridines/therapeutic use , Ritonavir/therapeutic use , Adenine/analogs & derivatives , Adenine/therapeutic use , Adult , Anti-HIV Agents/adverse effects , Antiretroviral Therapy, Highly Active/methods , Atazanavir Sulfate , CD4 Lymphocyte Count , Cohort Studies , Drug Administration Schedule , Drug Interactions , Female , HIV Protease Inhibitors/adverse effects , Humans , Kaplan-Meier Estimate , Male , Oligopeptides/adverse effects , Organophosphonates/therapeutic use , Pyridines/adverse effects , Reverse Transcriptase Inhibitors/therapeutic use , Ritonavir/adverse effects , Tenofovir , Treatment Outcome , Viral Load
11.
Infection ; 37(3): 244-9, 2009 Jun.
Article in English | MEDLINE | ID: mdl-19471856

ABSTRACT

BACKGROUND: Although the mechanism of atazanavir (ATV)-related hyperbilirubinemia is well identified, its prevalence, risk factors, and association with transaminase flares have rarely been assessed in a large population from the "real life" setting. METHODS: Prospectively collected data on 2,404 patients from the Italian MASTER Cohort and the Italian ATV expanded access program database were examined. Uni- and multivariable Cox proportional hazards regression models were conducted to identify risk factors for grade >or= III hyperbilirubinemia during the administration of ATV. The risk of increased levels of serum alanine aminotransferase (ALT) was compared between patients with or without grade >or= III hyperbilirubinemia in a Cox regression analysis stratified by hepatitis C virus (HCV) serostatus. RESULTS: Grade III and IV hyperbilirubinemia were observed in 1,072 (44.6%) and 174 (7.2%) of the patients, respectively. Higher CD4+ T-cell counts, abnormal bilirubinemia at baseline, and ritonavir co-administration were associated with a higher risk of developing grade >or= III hyperbilirubinemia. In contrast, female gender, clinical class C, and non-nucleoside reverse transcriptase co-administration appeared to be protective. Higher bilirubinemia at baseline and the use of ritonavir were associated with a higher risk of grade IV hyperbilirubinemia. The occurrence of grade >or= III hyperbilirubinemia was not associated with severe hepatotoxicity (hazard ratio 1.00, 95% confidence interval 0.64-1.57; p = 0.997). CONCLUSIONS: Hyperbilirubinemia is a common side effect of an ATV pharmacotherapeutic regimen. However, grade IV increase in bilirubin was rarely found. In most cases, ATV hyperbilirubinemia appeared to be an innocent phenomenon as far as the risk of a subsequent increase in liver enzyme level is concerned.


Subject(s)
Alanine Transaminase/blood , Anti-HIV Agents/adverse effects , HIV Infections/drug therapy , Hyperbilirubinemia/chemically induced , Liver/drug effects , Oligopeptides/adverse effects , Pyridines/adverse effects , Adult , Alanine Transaminase/metabolism , Analysis of Variance , Antiretroviral Therapy, Highly Active , Atazanavir Sulfate , CD4 Lymphocyte Count , Cohort Studies , Female , HIV Infections/complications , HIV Infections/pathology , Hepatitis C/complications , Hepatitis C/drug therapy , Humans , Hyperbilirubinemia/epidemiology , Hyperbilirubinemia/pathology , Liver/enzymology , Male , Multivariate Analysis , Prevalence , Proportional Hazards Models , Risk Factors , Ritonavir/therapeutic use , Severity of Illness Index
12.
Biomed Pharmacother ; 58(9): 505-8, 2004 Nov.
Article in English | MEDLINE | ID: mdl-15511607

ABSTRACT

In the last few years there are increasing evidences suggesting that osteopenia and osteoporosis are frequent among HIV positive patients. It is still not clear if the bone demineralization is a direct consequence of viral infection or of the antiretroviral drugs. Studies to date therefore give conflicting results. We performed a study to evaluate the prevalence of osteopenia and osteoporosis in HIV positive patients, either untreated or receiving antiretroviral therapy, to asses the frequency of these conditions and the role of antiretroviral drugs.


Subject(s)
Antiretroviral Therapy, Highly Active/adverse effects , Bone Diseases, Metabolic/diagnostic imaging , HIV Infections/diagnostic imaging , HIV Infections/drug therapy , Adult , Analysis of Variance , Bone Density/drug effects , Bone Density/physiology , Bone Diseases, Metabolic/chemically induced , Bone Diseases, Metabolic/epidemiology , Chi-Square Distribution , Female , HIV Infections/epidemiology , Humans , Male , Middle Aged , Osteoporosis/chemically induced , Osteoporosis/diagnostic imaging , Osteoporosis/epidemiology , Ultrasonography
14.
Minerva Med ; 93(2): 119-28, 2002 Apr.
Article in Italian | MEDLINE | ID: mdl-12032443

ABSTRACT

The incidence of latex allergy has increased in the last decade in particular for medical and health care staff. The "L. Sacco" Hospital in Milan has developed an organisational model for dealing with clinical problems of patients allergic to latex who need to be admitted in hospital. Guidelines have been drawn up to handle the problem of latex allergy in hospital. An Interdisciplinary Working Group has systematically re-examined the epidemiological, etiopathogenetic, clinical diagnostic and therapeutic aspects of this important medical problem. This last topic has been particularly developed to facilitate doctors with emergency drugs. Nevertheless the most efficient method against the sensitisation is the elimination and reduction in hospital of the allergens causing the disease.


Subject(s)
Latex Hypersensitivity/etiology , Occupational Diseases/etiology , Health Personnel , Humans , Latex Hypersensitivity/diagnosis , Latex Hypersensitivity/epidemiology , Latex Hypersensitivity/therapy , Occupational Diseases/diagnosis , Occupational Diseases/epidemiology , Occupational Diseases/therapy , Risk Factors
15.
Biomed Pharmacother ; 55(6): 321-3, 2001 Jul.
Article in English | MEDLINE | ID: mdl-11478584

ABSTRACT

Risk factors in the development of adverse reactions in HIV-1-infected patients treated with highly active antiretroviral therapy (HAART) containing protease inhibitors are poorly understood. To identify predictors of protease inhibitor-associated adverse events, we are conducting a prospective, cohort, multicenter study on HIV-positive patients starting treatment with at least one protease inhibitor. Rate ratios (RR) of adverse events were calculated, and logistic regression was used to adjust simultaneously for the potentially confounding effects of selected variables, according to the Cox model. A total of 1477 patients have been enrolled up to April 2000, having an average age of 37.1 years (SD +/- 8.1); 1066 (72.2%) were male. Where risk factors for HIV infection are concerned, the distribution was as follows: 48.1% intravenous drug users, 31.6% heterosexual contacts, 16.2% homosexual males and 0.7% blood transfusion. Average CD4+ lymphocyte count at enrollment was 265 cells/mmc (SD +/- 201). Average follow-up time is equal to 17.8 months (range 1-32). The risk of developing adverse reactions is significantly increased in female patients, older patients, hemophiliac subjects and in subjects with hepatitis. Patients treated with ritonavir, the association ritonavir-saquinavir HGC, stavudine and efavirenz have significantly increased incidence of adverse reactions in PI-containing regimens; conversely, saquinavir HGC, zidovudine and lamivudine use was associated with a lower risk of developing adverse reactions.


Subject(s)
HIV Infections/drug therapy , HIV-1/metabolism , Protease Inhibitors/adverse effects , Adult , Antiretroviral Therapy, Highly Active/adverse effects , Cohort Studies , Female , Humans , Male , Prospective Studies , Regression Analysis , Risk Factors , Safety Management/statistics & numerical data
17.
Orthopedics ; 24(3): 271-2, 2001 Mar.
Article in English | MEDLINE | ID: mdl-11300292

ABSTRACT

The introduction of protease inhibitors has proven a watershed in human immunodeficiency virus infection therapy and has initiated an era of highly active antiretroviral therapy. However, the numerous data on the effectiveness of these therapeutic regimens have been cited with an ever-growing number of communications concerning adverse reactions. In particular, the widescale use of protease inhibitors has underlined a series of events not evidenced in the controlled clinical studies that permitted the registration of these drugs. We are conducting a cohort multicenter study to evaluate the incidence of adverse events during treatment with protease inhibitors. To date, 4 cases of bilateral osteonecrosis of the femoral head have been reported out of 1073 person-years. While the pathogenesis of this event is unclear, it may be a long-term complication of protease inhibitor treatment.


Subject(s)
HIV Infections/drug therapy , HIV Protease Inhibitors/adverse effects , Osteonecrosis/chemically induced , Adult , Cohort Studies , Female , Follow-Up Studies , HIV Infections/diagnosis , HIV Protease Inhibitors/therapeutic use , Humans , Incidence , Male , Osteonecrosis/epidemiology , Risk Assessment
18.
Antivir Ther ; 5(3): 195-7, 2000 Sep.
Article in English | MEDLINE | ID: mdl-11075939

ABSTRACT

The aim of our study is to compare the tolerability of zidovudine/lamivudine/indinavir when used in post-exposure prophylaxis (PEP) subjects and in HIV-infected patients. HIV-negative patients were enrolled as part of the surveillance protocol for professional exposure at the Luigi Sacco Hospital in Milan. HIV-positive patients were selected among all subjects undergoing treatment with zidovudine/lamivudine/indinavir from the CISAI cohort, an Italian cohort for the evaluation of adverse reactions to HAART. In both studies patients were followed prospectively and the severity of the reactions was evaluated using the AIDS Clinical Trial Group adverse experience grading scales. Up to September 1999, 37 HIV-seronegative subjects had undergone treatment with zidovudine/ lamivudine/indinavir. From a total of 1207 patients belonging to the CISAI cohort, 199 were identified as being treated with the same regimen. The frequency of adverse events in the PEP subjects was 70.3% compared to 11.1% for HIV-infected patients. In the first group, adverse events caused treatment interruption in 21 subjects (56.7%) versus 14 patients (7%) among the HIV-infected group. Only one case of a severe event (grade 3-4) was observed in the prophylaxis group against 12 in the treatment group. Our study shows that treatment interruption is eight times higher in HIV-negative subjects compared to HIV-seropositive patients, and that the incidence of adverse events is approximately six times higher, though such events, are for the most part, not severe.


Subject(s)
Anti-HIV Agents/adverse effects , Anti-HIV Agents/therapeutic use , Antiretroviral Therapy, Highly Active/adverse effects , HIV Infections/drug therapy , HIV Infections/prevention & control , Health Personnel , Adult , Chemoprevention , Female , Humans , Indinavir/adverse effects , Indinavir/therapeutic use , Lamivudine/adverse effects , Lamivudine/therapeutic use , Male , Middle Aged , Reverse Transcriptase Inhibitors/adverse effects , Reverse Transcriptase Inhibitors/therapeutic use , Zidovudine/adverse effects , Zidovudine/therapeutic use
19.
J Acquir Immune Defic Syndr ; 23(3): 236-45, 2000 Mar 01.
Article in English | MEDLINE | ID: mdl-10839659

ABSTRACT

OBJECTIVE: To assess the probability that protease inhibitor (PI) therapy might be discontinued because of adverse events (AE) and to evaluate the incidence rate of adverse reactions during PI treatment. DESIGN: A prospective cohort, multicenter study on HIV-positive patients starting treatment with at least one PI. SETTING: Ten departments of infectious diseases in Northern Italy. PATIENTS: A total of 1207 patients who started PI therapy in September 1997 and were consecutively observed up to April 1999. MAIN OUTCOME MEASURES: Adverse reactions following initiation of PI therapy, and time to therapy discontinuation due to AE. RESULTS: During the study period, 35.9% patients presented adverse reactions of any grade, whereas 9.7% presented at least one serious AE. After 12 months of treatment, the percentage of patients who had interrupted treatment was 36% of ritonavir-treated patients, 14.2% of those treated with indinavir, 13.6% of ritonavir-saquinavir hard gel capsules (HGC)-treated patients, and 8.5% and 2.1%, respectively, for those treated with nelfinavir and saquinavir HGC. Women and patients with hepatitis experienced a significantly greater number of adverse events compared with other categories. Gastrointestinal events were more frequently observed in patients treated with either ritonavir alone or in combination with saquinavir HGC, as well as in patients receiving nelfinavir, although in this group serious events were rare. Here again, neurologic, metabolic, and hepatic toxicity occurred more frequently in ritonavir and ritonavir-saquinavir HGC treated patients. Allergic reactions were more often observed in patients receiving nelfinavir. Indinavir-treated patients presented the highest incidence of renal toxicity. CONCLUSION: Ritonavir is the drug associated with the largest number of reactions, which appear during the first few months of treatment. Saquinavir HGC and nelfinavir are the best tolerated drugs in a clinical setting.


Subject(s)
HIV Protease Inhibitors/adverse effects , HIV Seropositivity/drug therapy , Adult , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Cohort Studies , Confidence Intervals , Drug Monitoring/statistics & numerical data , Female , Follow-Up Studies , HIV Protease Inhibitors/therapeutic use , HIV Seropositivity/epidemiology , Humans , Incidence , Indinavir/adverse effects , Indinavir/therapeutic use , Italy/epidemiology , Male , Middle Aged , Multivariate Analysis , Nelfinavir/adverse effects , Nelfinavir/therapeutic use , Prospective Studies , Risk Factors , Ritonavir/adverse effects , Ritonavir/therapeutic use , Saquinavir/adverse effects , Saquinavir/therapeutic use
20.
Biomed Pharmacother ; 54(1): 45-9, 2000 Feb.
Article in English | MEDLINE | ID: mdl-10721462

ABSTRACT

Our study was undertaken to evaluate if desensitization treatment is more effective than rechallenge in preventing hypersensitivity reactions in HIV-positive patients with previous allergic reactions to TMP-SMX; the secondary aim was to evaluate the frequency of reactions to TMP alone. This was a randomized, multicentre open study. Patients with previous documented hypersensitivity to TMP-SMX who required primary or secondary PCP prophylaxis were enrolled; subjects who had previously had serious adverse reactions to TMP-SMX were excluded. All eligible patients assumed 200 mg TMP for 14 days and in case of no reactions were randomized for desensitization or rechallenge with TMP-SMX. The patients were then followed up by periodical visits for six months. Seventy-three patients were enrolled; 14 subjects (19%) presented reactions on TMP alone during the pre-enrollment phase. The remaining 59 subjects were randomly assigned to the two treatment groups: 34 carried out desensitization (group 1) and 25 rechallenge (group 2) with TMP-SMX. Seven patients in group 1 (20.5%) and seven in group 2 (28%) showed hypersensitivity reactions during treatment; this difference was not statistically significant. No serious reaction occurred in either group. This study showed the comparable effectiveness of the desensitization procedure and rechallenge in patients with a previous, not serious, allergic reaction to TMP-SMX.


Subject(s)
Desensitization, Immunologic , Drug Hypersensitivity/therapy , HIV Seropositivity/immunology , Trimethoprim, Sulfamethoxazole Drug Combination/adverse effects , Adult , Drug Hypersensitivity/diagnosis , Female , Humans , Male , Treatment Outcome
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