rome and Acquired-Immunodeficiency-Syndrome

The aim of this paper is to assess the methodological problems of an unsuccessful randomized controlled trial (RCT) conducted to evaluate the effectiveness, in terms of survival and quality of life, of the early offer of home care (HC) to persons with AIDS (PWA). The study carried out was an intention-to-treat RCT. Persons in the treatment group (TG) received the offer of HC at the moment of AIDS diagnosis; those in the control group (CG) received it six months from diagnosis. Many problems have hindered the progress of the study: particularly, the low compliance to the offer and the failure to enroll the required sample size have made the results unreliable. Analogous problems have been reported within other trials evaluating HC in different fields. The present study thoroughly evaluates the specific ethical and methodological problems encountered in designing and conducting a RCT on HC for PWA. We conclude that, before designing and conducting a RCT in this field, it is advisable to examine some main issues carefully, such as the acceptability of the offer of treatment, the expected compliance and the required size of the study population. If one or more of these elements prove to be problematic, the results of the trial risk being seriously compromised, and alternative approaches should be considered.

Topics: Acquired Immunodeficiency Syndrome; Adolescent; Adult; Home Care Services; Humans; Patient Compliance; Quality of Life; Research Design; Rome; Sample Size; Software Design

Topics: Acquired Immunodeficiency Syndrome; Africa; Carica; Catholicism; Condoms; Humans; Male; Paris; Parkinson Disease; Phytotherapy; Plant Preparations; Rome

To analyse overall and cause-specific mortality among problem drug users (PDUs) attending treatment centres in Rome and to evaluate differences in mortality between genders.. A cohort of 11 432 PDUs entering treatment in Rome between 1980 and 1995 was enrolled and followed-up as of May 31, 1997. Directly standardized mortality rates and standardized mortality ratios (SMRs) and their 95% confidence intervals (95% CI) were calculated.. The study population included mainly males (82%), heroin users (92%) and had a mean age of 26.6 (SD 5.9) at enrollment. At the end of the study period 1734 deaths were observed. Overall mortality rates began to increase in 1985-86 and decreased slightly afterwards. AIDS mortality peaked in 1991-92 (13.2/1000) and fell in the following years. A slight decrease in overdose mortality also occurred after 1989-90. Mortality for causes other than AIDS and overdose remained high and relatively steady for the whole study period. Women showed higher mortality rates for AIDS but lower mortality rates for overdose than males. Overall mortality risk among drug addicts was about 15 times higher compared to the general population of the same age among men, and 38 times higher among women.. AIDS mortality among drug addicts began to decrease earlier than expected; the decrease was particularly significant in the period 1993-94 for both sexes. Afterwards a continuous but slight decrease was observed among males only. Even though overdose mortality has also decreased slightly in recent years, we still observe high mortality levels for both overdose and all other causes. These findings suggest that interventions directed specifically towards the reduction of baseline mortality are still needed.

Topics: Acquired Immunodeficiency Syndrome; Adult; Cause of Death; Drug Overdose; Female; Follow-Up Studies; Humans; Male; Poisson Distribution; Rome; Sex Factors; Substance-Related Disorders

We estimated the AIDS survival by neighborhood socioeconomic status before (1993-1995) and after (1996-1997) the introduction of highly active antiretroviral therapy in Rome, Italy, in a retrospective cohort of persons with AIDS followed through July 31, 1998. Participants included 1,474 persons with AIDS residing in Rome who were diagnosed in 1993-1997. We calculated hazard ratios (HRs) of death for two diagnostic periods (before and after highly active antiretroviral therapy was introduced) by neighborhood socioeconomic status categorized into four levels (level I = highest socioeconomic status), using the Cox model and adjusting for gender, age, intravenous drug use, CD4 cell count at diagnosis, AIDS-defining disease, and hospital of diagnosis. Thirty-four per cent of persons with AIDS (N = 503) had survived as of mid-1998. For persons with AIDS diagnosed in 1993-1995, we found little difference in the risk of death by neighborhood socioeconomic status. For 1996-1997, the risk of death was greater for persons with lower neighborhood socioeconomic status, especially for levels III and IV [HR = 2.81 (95% confidence interval = 1.38-5.76), and HR = 2.55 (95% confidence interval = 1.27-5.14), respectively, compared with level I]. Stratified analyses showed that the greatest difference was found for women and drug users. In conclusion, even in a country with universal health coverage that provides therapy at no cost, differences in survival of persons with AIDS have emerged by neighborhood socioeconomic status since highly active antiretroviral therapy was introduced. Inequalities in health-care access or in medical management, or poor adherence to treatment, could explain the observed heterogeneity.

Topics: Acquired Immunodeficiency Syndrome; Adult; Antiretroviral Therapy, Highly Active; Cause of Death; Cohort Studies; Female; Humans; Male; Population Surveillance; Proportional Hazards Models; Retrospective Studies; Risk Factors; Rome; Social Class; Survival Analysis; Urban Population

A multidisciplinary home care service for people with AIDS (PWAs) was started in Rome in September 1990. This paper describes the features of the home care service offered by the Associated Health Care Workers' Co-operative (OSA), an example of the integration of private and state systems. We detail the types and numbers of visits that PWAs have needed, and we explore the possible correlation between demographic and clinical variables and the care required. As of September 1994 service had been provided to 372 PWAs. During the 4-year period, 62,927 home care visits were made (an average of 4.3 visits/patient/week): 66% were made by psychologists, social workers and home helps, and 34% by health professionals. PWAs who, at the outset of their home care, suffered from AIDS-dementia complex (ADC), toxoplasmosis, wasting syndrome or cytomegalovirus retinitis required the highest number of visits. Psychologists, social workers and home care helps made more frequent visits than health professionals for all AIDS-defining conditions except retinitis (for which 63% of visits were for health care). Our study shows that careful assessment of patients receiving home care helps in planning visits and in organizing available resources. A controlled randomized multicentre study is under way with the aim of determining the effectiveness of home care in terms of survival, quality of life and care workload and related costs.

Topics: Acquired Immunodeficiency Syndrome; Adult; Aged; Catchment Area, Health; Female; Health Services Needs and Demand; Home Care Services; House Calls; Humans; Male; Middle Aged; Patient Care Team; Private Sector; Rome; State Medicine; Urban Health Services

The purpose of the study was to analyze overall and cause-specific mortality among injection drug users in Rome.. A cohort of 4200 injection drug users was enrolled in drug treatment centers from 1980 through 1988 and followed up until December 1992.. The age-adjusted mortality rate from all causes increased from 7.8/1000 person-years in 1985/86 to 27.7/1000 in 1991/92. The rise was mainly attributable to acquired immunodeficiency syndrome (AIDS), but mortality from overdose and other causes increased as well. The cumulative risk of death by the age of 40 was 29.3%.. The impact of AIDS deaths appears to be additional to a persistent increase of mortality for all other causes.

Topics: Acquired Immunodeficiency Syndrome; Cause of Death; Cohort Studies; Female; Follow-Up Studies; Humans; Male; Mortality; Risk; Rome; Sex Distribution; Substance Abuse, Intravenous

To determine whether human T-lymphotropic virus (HTLV) type II coinfection affects progression of human immunodeficiency virus type 1 (HIV) infection, longitudinal data on 370 HIV-infected injection drug users (IDUs) with known HIV seroconversion dates from four cohort studies were pooled. HTLV infection was determined by EIA and confirmed and typed by Western blot. Proportional hazards models were used to determine whether HTLV-II infection was associated with AIDS or AIDS-related mortality. Regression analyses were used to compare declines in CD4 cell percents in singly and dually infected persons. Of 370 IDUs, 61 (16%) were HTLV-II-coinfected. During follow-up, 43 (12%) developed and 24 (6%) died of AIDS. HTLV-II coinfection was not associated with progression to AIDS (relative hazard [RH], .82; 95% confidence interval [CI], 0.34-1.94]) or AIDS mortality (RH, 1.69; 95% CI, 0.62-4.60). Rates of decline in CD4 cell percent were similar in singly and dually infected IDUs. These results suggest that HTLV-II does not affect the progression of HIV infection.

Topics: Acquired Immunodeficiency Syndrome; Adult; CD4 Lymphocyte Count; Disease Progression; Follow-Up Studies; HIV Seropositivity; HIV-1; HTLV-II Infections; Humans; Longitudinal Studies; Multivariate Analysis; Prevalence; Regression Analysis; Rome; Substance Abuse, Intravenous; Time Factors; United States

Two cross-sectional surveys have been conducted in Rome in 1990 and 1992 to investigate prevalence and temporal differences of risk behaviours among drug injectors. A total of 487 drug injectors in 1990, and 450 in 1992 have been interviewed both in the street and in treatment services. Twenty-four percent of the subjects interviewed in 1990 reported having used second-hand syringes in the preceding 6 months, as compared to 14% in 1992; in the two years 29% and 13%, respectively, reported having passed a second-hand syringe to other drug injectors. Fifty-six percent (46% in 1992) of primary partners of drug injectors interviewed were not drug users themselves, while the prevalence of non drug using occasional partners was 34% and 43% in the two surveys. In 1990 condom use with primary partner was reported by 48% of drug injectors, and by 41% in 1992; condom use with occasional partners was 56% and 64% in the two years. The differences in sharing behaviours were observed for HIV-1 positive subjects, while HIV-1 negatives reported the same prevalence of use of second-hand syringes in 1990 and 1992; no statistically significant differences have been found for sexual behaviours among the HIV-1 positives, while the HIV-1 negatives reported a lower prevalence of condom use with primary partner. The observed differences in the two years remain also adjusting for the socio-demographic characteristics of the two populations in a multiple logistic regression model. Prevalence of HIV-1 related risk behaviours among drug injectors is still too high.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acquired Immunodeficiency Syndrome; Adult; Cross-Sectional Studies; Female; HIV-1; Humans; Logistic Models; Male; Risk-Taking; Rome; Substance-Related Disorders

In Italy, care for people with AIDS (PWA) is centred on hospital services. However, other services are beginning to develop, both in the form of residential facilities and of home care. It seems, therefore, important to define the type of non-hospital services that should be supplied on the basis of AIDS patients' real needs. The aim of this paper is to contribute to the definition of care requirements by administration to 92 persons with ARC/AIDS of a questionnaire on Functional Multidimensional Evaluation to assess the demand for services in relation to the state of health and socio-economic situation of those interviewed. The pattern that emerged was one of severe socio-economic difficulties (most of the patients were drug addicts) and of major functional impairment (about 60% of those interviewed were not self-sufficient as far as Instrumental Activities of Daily Living were concerned). Among the main problems: difficulties of finding accommodation (almost 9% of those interviewed have no fixed abode) and economic difficulties; the demand for services was characterized by a lack of self-sufficiency. The most frequently required social services were help with preparation of meals, household chores and assistance with transport; the most frequently required health service was physiotherapy, which is also the least available. The study supplies useful information for the planning of non-hospital services in Italy and in other western countries with similar epidemiological situations.

Topics: Acquired Immunodeficiency Syndrome; Activities of Daily Living; Adult; AIDS-Related Complex; Female; Health Resources; Health Services Needs and Demand; HIV Seroprevalence; Humans; Male; Middle Aged; Patient Admission; Rome; Socioeconomic Factors; Urban Health

The goal of our study was to evaluate the incidence of heart involvement in AIDS patients during various stages of the disease. Between January 1988 to September 1991, we conducted a prospective study in 114 anti-HIV positive patients. The patients, whose mean age (+/- SD) was 34.6 +/- 5.4 years (range 20 to 54), were divided into three groups: anti-HIV positive asymptomatic (n = 31; 27%), AIDS related complex (ARC) group IV-A (n = 11; 10%), and AIDS subgroups IV-C1 (n = 62; 54%) and IV-D (n = 10; 9%). Overall, 84 patients (74%) were i.v. drug abusers, 24 (21%) were homosexuals, and six (5%) were partners at risk. Zidovudine (AZT) was administered to 94 patients (82%). Opportunistic infections and/or secondary malignancies were detected in 72 patients (63%). Electrocardiographic changes were of little clinical relevance. Of 72 AIDS patients, 47 (65.2%) presented a cardiac involvement: 12 subjects (16.6%) were affected by a dilated cardiomyopathy, 13 (18%) by pericardial effusion, three (4.1%) by mitral valve prolapse, four (5.5%) by myocarditis, five (6.9%) by valvular bacterial endocarditis, and 10 (13.8%) by alterations of left ventricle regional contractility. During a mean follow-up period of 44 months, 29 AIDS patients (40.2%) died. Death was attributed to a cardiac event in four patients; autopsy could be performed in 24 of the 29 patients who died. Our results demonstrate that heart involvement is present in 45.6% of HIV-infected patients, but only in the end-stage of the disease (AIDS) and it is presumably due to opportunistic infections and/or secondary malignancies.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acquired Immunodeficiency Syndrome; Adult; AIDS-Related Opportunistic Infections; Echocardiography; Female; Heart Diseases; Humans; Incidence; Male; Prospective Studies; Risk Factors; Rome; Substance Abuse, Intravenous

Topics: Acquired Immunodeficiency Syndrome; Adolescent; Adult; AIDS-Related Opportunistic Infections; Bronchoalveolar Lavage Fluid; Female; Humans; Male; Middle Aged; Pneumocystis; Pneumonia, Pneumocystis; Rome; Sputum

A chronic coinfection with CMV, EBV etc. has been described in patients with HIV infection; recently a coinfection with other retroviruses has been described too. We have looked for the presence of antibodies to HTLV-I (anti HTLV-I) and to HIV-2 (anti HIV-2) in 135 HIV infected (HIV-positive) subjects living in Rome. They were 100 i.v. drug addicts, 24 homo/bisexuals, 4 partners of HIV-positive patients, 5 polytransfused and 2 without any known risk factor; 32 of them had a full-blown AIDS, 52 had ARC and 51 were symptom-free. Anti HIV, anti HTLV-I and anti HIV-2 were detected with ELISA method and confirmed by Western Blot (W.B.) technique. Antibodies to HTLV-I were found in 14 cases (10.4%) and antibodies to HIV-2 in 12 cases (8.9%). The contemporary presence of anti HIV, anti HTLV-I and anti HIV-2 was not found in any subjects. Our data fail to show a clear relationship among the coinfection with different retroviruses and the various risk factors for HIV infection and the HIV-related clinical picture (AIDS, ARC, etc.).

Topics: Acquired Immunodeficiency Syndrome; Adolescent; Adult; Aged; AIDS-Related Complex; Cross-Sectional Studies; Deltaretrovirus Antibodies; Deltaretrovirus Infections; Female; HIV Antibodies; HIV Infections; HIV-1; HIV-2; Human T-lymphotropic virus 1; Humans; Male; Middle Aged; Prognosis; Risk Factors; Rome

Topics: Acquired Immunodeficiency Syndrome; Cytomegalovirus; Female; Homosexuality; Humans; Lymphoma; Male; Risk; Rome; T-Lymphocytes, Helper-Inducer; T-Lymphocytes, Regulatory; Thymus Extracts