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 , UltrasonographyABSTRACT
BACKGROUND: Highly active antiretroviral therapy (HAART) is strongly effective in reducing morbidity and mortality in HIV-1-positive individuals. Its main drawback is the potential toxicity. Data on the frequency and determinants of severe hepatotoxicity in a clinical setting are still sparse. METHODS: This is a prospective study of HIV-1-positive individuals with known HBsAg and HCV-Ab serology. The study end point was progression to alanine aminotransferase (ALT) levels > or =200 IU/L after HAART initiation. Cumulative probability of progression to this end point was estimated by the Kaplan-Meier method. Crude and adjusted hazard ratios (HR) were estimated by proportional hazards regression model. RESULTS: One thousand two hundred fifty-five patients were included. HBsAg was found in 91 (7.2%), HCV-Ab in 578 (46.5%) patients; almost all injection drug users (451 of 482; 93.6%) were HCV-Ab positive. Sixty-one individuals progressed to the end point with a probability of 7.9% (95% confidence interval [CI], 5.6-10.0) of progression at 24 months from starting. Independent factors predicting progression to the end point were baseline ALT levels (HR, 5.29; 95% CI, 3.24-8.65; every 10 IU/L higher), HCV-Ab positivity (HR, 4.01; 95% CI, 1.48-10.85) or both HBsAg and HCV Ab positivity (HR, 3.85, 95% CI, 1.01-14.61), and previous non-HAART therapy (HR, 1.84, 95% CI, 1.04-3.42). Patients receiving stavudine-containing regimens had a lower risk than those receiving zidovudine-containing regimens (HR, 0.30, 95% CI, 0.12-0.71). CONCLUSIONS: There was a low risk of ALT > or =200 IU/L in our cohort. Hepatitis C coinfection and elevated ALT levels at HAART initiation are important predictors of progression to ALT > or =200 IU/L; stavudine-containing regimens were associated with a lower risk compared with zidovudine-containing regimens.
Subject(s)
Hepatitis C/complications , Alanine Transaminase/blood , Anti-HIV Agents/therapeutic use , Antiretroviral Therapy, Highly Active , Cohort Studies , Disease Progression , Female , HIV Seropositivity/complications , HIV-1/isolation & purification , Hepatitis B Surface Antigens/analysis , Humans , Male , Proportional Hazards Models , Stavudine , Zidovudine/therapeutic useABSTRACT
PURPOSE: To compare in a real clinical setting the largely unknown midterm clinical effectiveness of two protease inhibitor (PI)-based highly active antiretroviral therapy (HAART) regimens with different potency and tolerability profiles in naïve patients. METHOD: This study was a multicenter, open-label, randomized trial in naïve patients with less than 400 CD4+ cell count/microL, regardless of viral load. Treatment arms were hard gel capsule saquinavir (HGC-SQV)-based HAART (Arm A), with an expected more favorable tolerability profile, and indinavir (IDV)-based HAART (Arm B), with more potent virologic activity. While viro-immunological surrogate markers and World Health Organization (WHO) grade III toxicity (secondary endpoints) were regularly monitored, primary endpoints of the study were clinical and defined as any AIDS-defining event, AIDS-related death, WHO grade IV toxicity, drop outs, and protocol violations. RESULTS: 262 consecutive patients were enrolled in the study from March 1, 1997 to December 31, 1997, in 24 different Italian clinical centers (132, Arm A; 130, Arm B). After 24 months of follow-up, patients who were enrolled in Arm B showed a significantly higher rate of virological success (75% had viremia below 500 copies/mL, CI = 12.9%, in the on-treatment analysis) and immunological gain (mean CD4+ cell count increase of 274 CD4+ cells/microL, SD = 234) when compared to patients enrolled in arm A (57%, CI = 15.5% and 223 CD4+ cells/microL, SD = 192; p =.0353 and.026, respectively). Despite the significant difference observed in surrogate markers, the number of total primary endpoints did not differ in the two groups (55 out of 132 in Arm A vs. 58 out of 130 person-years in Arm B; p =.86). CONCLUSION: Our results suggest that, after 24 months of follow-up in a real clinical setting, a PI-based HAART induces significant clinical benefits in naïve patients even in the absence of a complete suppression of viral replication. However, the long-term clinical impact of the possible accumulation of viral mutations in the presence of low-grade viral replication remains to be elucidated.
Subject(s)
Anti-HIV Agents/therapeutic use , HIV Infections/drug therapy , HIV Protease Inhibitors/therapeutic use , Adult , Antiretroviral Therapy, Highly Active , CD4 Lymphocyte Count , Cohort Studies , Female , HIV Infections/immunology , HIV Infections/virology , Humans , Indinavir/therapeutic use , Italy , Male , Prospective Studies , Saquinavir/therapeutic use , Viral LoadABSTRACT
This observational cohort study of 4,160 AIDS patients hospitalised in a single institution in northern Italy between January 1985 and December 1999 was carried out in order to assess the natural history of cryptococcosis, the epidemiological trend of this opportunistic infection, the risk factors predictive of death at 10 weeks, the response to therapy, and autopsy findings. Cryptococcosis was diagnosed in 177 (4.2%) patients and was the AIDS-defining disease in 2.8% of cases. Its prevalence decreased significantly over time (from 6.4% in the period 1985-1989 to 5.7% in 1990-1993, 3.1% in 1994-1996, and 1.9% in 1997-1999, P <0.0001). Although neurologic disease was the most frequent clinical picture, a significant proportion of the patients (24.2%) presented with extraneural cryptococcosis. In a Cox multivariate analysis, high titres of cerebrospinal fluid antigen (>5000) and drug addiction were predictive of death at 10 weeks. A complete clinical and mycological response was achieved in 60.8% of the treated patients, with the highest response rate being observed in those treated with amphotericin plus flucytosine (66.6%). Cryptococcosis relapsed in 12.8% of patients on secondary prophylaxis. Autopsy findings demonstrated that cryptococcosis is a disseminated disease, but long-term antifungal treatment may be able to eradicate it in a subgroup of patients.
Subject(s)
AIDS-Related Opportunistic Infections/epidemiology , AIDS-Related Opportunistic Infections/microbiology , Cause of Death , Cryptococcosis/epidemiology , Fungemia/epidemiology , AIDS-Related Opportunistic Infections/drug therapy , Adult , Aged , Antifungal Agents/administration & dosage , Autopsy , Cohort Studies , Cryptococcosis/diagnosis , Cryptococcosis/drug therapy , Female , Fungemia/diagnosis , Fungemia/drug therapy , Humans , Italy/epidemiology , Male , Middle Aged , Prevalence , Probability , Prognosis , Retrospective Studies , Risk Factors , Severity of Illness Index , Survival AnalysisABSTRACT
BACKGROUND: International migrants represent only 4.5% of the world's population, but they may become a challenge for host countries. The aim of the study was to assess the impact of this population on health parameters in Como county, on the northern border of Italy. METHODS: A retrospective analysis of migrants' admissions at Sant'Anna Hospital in 1998 was done, and compared to data from 1994. RESULTS: Of 47,378 total admissions at our hospital, 268 involved migrants (0.5%), mostly from the former Yugoslavia, with a slight preponderance of females; 22 out of 268 migrants were admitted in the Infectious Diseases Department (8.2%), mainly from Africa. Most admissions were classified as Drug Related Group (DRG), but an increasing number of miscellaneous DRGs are reported, including obstetric ones. CONCLUSIONS: The emergence of a female population among migrant admissions, and the relevance of delivery DRGs in 1998, may suggest that, after a first immigration wave of rather healthy men in search of good job opportunities during the first years of the 90s, we are now observing a second wave of migrants: their families. The increasing number of patients from the former Yugoslavia reported in 1998, could suggest that a third wave is expected in the near future: these will be irregular migrants and refugees.
Subject(s)
Communicable Diseases/epidemiology , Emigration and Immigration , Hospitalization/statistics & numerical data , Female , Humans , Incidence , Italy/epidemiology , Male , Retrospective StudiesABSTRACT
Since January 1985 more than 100 patients with deep fungal infections have been treated with itraconazole (200 to 400 mg/day) in Northern Italy. Evaluation of the drug efficacy and tolerance was possible in one patient with sporotrichosis, in 34 with aspergillosis, and in 36 with cryptococcosis (mainly patients positive for human immunodeficiency virus). Response to itraconazole alone was obtained in the case of sporotrichosis and in 24 of 34 patients with different forms of aspergillosis (of the 18 patients with invasive pulmonary aspergillosis, 15 were cured). Patients with cryptococcosis received itraconazole for active infection and/or for prevention of relapse. Active infection was treated successfully with itraconazole alone in 9 of 12 patients and with itraconazole plus flucytosine in 8 of 10 patients. Of the 31 patients who received itraconazole maintenance therapy for up to 27 months, 4 (13%) had relapses; 14 (45%) did not have relapses, and decline of serum antigen was detected in 12 of them; and 13 (42%) were completely cured (serum antigen titer dropped to zero). With the exception of hypokalemia in one patient, itraconazole was well tolerated even in patients who received the drug for several months or years.
Subject(s)
Antifungal Agents/therapeutic use , Ketoconazole/analogs & derivatives , Mycoses/drug therapy , Aspergillosis/drug therapy , Child , Cryptococcosis/drug therapy , Drug Administration Schedule , Humans , Itraconazole , Ketoconazole/therapeutic use , Mycoses/diagnosis , Patient Compliance , Recurrence , Remission Induction , Sporotrichosis/drug therapySubject(s)
Acquired Immunodeficiency Syndrome/complications , Cryptococcosis/complications , Meningitis/complications , Opportunistic Infections/complications , Adult , Cryptococcosis/cerebrospinal fluid , Cryptococcosis/physiopathology , Female , Humans , Male , Meningitis/cerebrospinal fluid , Meningitis/physiopathology , Middle Aged , Opportunistic Infections/cerebrospinal fluid , Opportunistic Infections/physiopathologySubject(s)
Acquired Immunodeficiency Syndrome/complications , Lymphoma/etiology , Adult , Female , Humans , Lymphoma/pathology , Male , Retrospective Studies , RiskABSTRACT
Beta-interferon was administered by intravenous infusion to 16 patients affected with fulminant hepatitis B virus infection in third or fourth-grade coma. Ten patients presented a superinfection or a co-infection due to the delta (delta)-agent. None had detectable interferon (IFN) activity before therapy was begun. Besides fever, no significant side-effects were observed during treatment. Both the IFN-treated group as well as the "historical" control group, made up of 70 cases of fulminant virus hepatitis, not treated with IFN and observed during a previous ten year-period, received supportive therapy; survival rates were similar in both groups. Furthermore, the presence or absence of the delta-agent did not appear to affect survival rates significantly.
Subject(s)
Hepatitis B/therapy , Interferon Type I/therapeutic use , Adolescent , Adult , Clinical Trials as Topic , Female , Hepatitis B/blood , Hepatitis B/immunology , Hepatitis B Antigens/analysis , Hepatitis delta Antigens , Humans , Infusions, Parenteral , Interferon Type I/administration & dosage , Interferon Type I/blood , MaleABSTRACT
The immune response in a 49-year-old Italian nun affected by Tetrapetalomena (Dipetalonema) perstans following an eight-year stay in Cameroon is reported. On admission the patient presented with polyarthralgia, conjunctival pruritus and irritation, oedema of the limbs, generalized itching, hypereosinophilia and low total IgE titre. During diethylcarbamazine treatment and, subsequently, during mebendazole administration, an exacerbation of her symptoms was observed. At the same time, activation of the alternative complement pathway and the appearance of circulating immune complexes were noted, suggesting a type III hypersensitivity reaction. Circulating immune complexes and diethylcarbamazine-induced release of parasitic antigens may also be considered responsible for the decrease of OKT3 and OKT4 positive lymphocytes.
Subject(s)
Dipetalonema Infections/immunology , Filariasis/immunology , Antibody Formation , Cameroon , Diethylcarbamazine/therapeutic use , Dipetalonema Infections/drug therapy , Female , Humans , Immunoglobulin E/biosynthesis , Mebendazole/therapeutic use , Middle AgedABSTRACT
Ten patients affected by fulminant viral hepatitis (F.V.H.) were treated with anti-lymphocyte globulins (A.L.G.) besides peritoneal dialysis (P.D.) and exchange blood transfusion (E.T.). Two patients awoke transiently; six recovered from F.V.H., but two of them died afterwards due to later complications. The total of complete recovery was 40%; this result is compared with those previously obtained by the Authors in 38 patients treated only with P.D. and E.T. (28.9% complete recovery), and in seven patients treated with P.D., E.T. and human anti-HBsAg gamma globulins (28.5% complete recovery). The treatment with A.L.G. was performed because of the discouraging results until now obtained with the various liver support systems and is based on the accepted view that lymphocytes might be the true effectors of cell necrosis in F.V.H.
Subject(s)
Antilymphocyte Serum/therapeutic use , Hepatitis, Viral, Human/therapy , Acute Disease , Adolescent , Adult , Antibody Formation , Child , Dexamethasone/administration & dosage , Dexamethasone/therapeutic use , Female , Glucose/administration & dosage , Glucose/therapeutic use , Hepatitis, Viral, Human/drug therapy , Hepatitis, Viral, Human/immunology , Humans , Lactulose/administration & dosage , Lactulose/therapeutic use , Male , Middle Aged , Neomycin/administration & dosage , Neomycin/therapeutic use , Peritoneal Dialysis , Rosette FormationABSTRACT
The results of some clinical trials performed with levamisole on 12 HBsAg-positive subjects, including 5 patients with aggressive chronic hepatitis, (ACH) 2 patients with persistent chronic hepatitis (PCH) and 5 healthy carriers are reported. Levamisole was administered in 2.5 mg/Kg/day doses for three consecutive days. During treatment prothrombin activity normalized in ACH and PCH as well as transaminases, the latter starting from the 4th week, even though a two-fourfold increase of the starting values was observed in the first weeks of disease. HBsAg, anti-HBs titres and immunocomplexes values did not show any significant variations, but for 1 case, while some immunological parameters (E, EA rosettes) normalized in those cases showing base- values lower than the norm.