Parallel conduction of the phase I preventive and therapeutic trials based on the Tat vaccine candidate.

The native HIV-1 Tat protein was chosen as vaccine candidate for phase I clinical trials in both uninfected (ClinicalTrials.gov identifier: NCT00529698) and infected volunteers (ClinicalTrials.gov identifier: NCT00505401). The rationale was based on the role of Tat in the natural infection and AIDS pathogenesis, on the association of Tat-specific immune responses with the asymptomatic stage and slow-progression rate as well as on its sequence conservation among HIV clades (http://www.hiv1tat-vaccines.info/). The parallel conduction in the same clinical centers of randomized, double blind, placebo-controlled phase I studies both in healthy, immunologically competent adults and in HIV-infected, clinically asymptomatic, individuals represents a unique occasion to compare the vaccine-induced immune response in both the preventive and therapeutic setting. In both studies, the same lot of the native Tat protein was administered 5 times, every four weeks, subcute (SC) with alum adjuvant or intradermic (ID), in the absence of adjuvant, at 7.5 microg, 15 microg or 30 microg doses, respectively. The primary and secondary endpoints of these studies were the safety and immunogenicity of the vaccine candidate, respectively. The study lasted 52 weeks and monitoring was conducted for on additional 3 years. The results of both studies indicated that the Tat vaccine is safe and well tolerated both locally and systemically and it is highly immunogenic at all the dosages and by both routes of administration. Vaccination with Tat induced a balanced immune response in uninfected and infected individuals. In particular, therapeutic immunization induced functional antibodies and partially reverted the marked Th1 polarization of anti-Tat immunity seen in natural infection, and elicited a more balanced Th1/Th2 immune response. Further, the number of CD4 T cells correlated positively with anti-Tat antibody titers. Based on these results, a phase II study is ongoing in infected drug-treated individuals (http://www.hiv1tat-vaccines.info/).

Prediction of adherence to antiretroviral therapy: can patients' gender play some role? An Italian pilot study.

Recent literature has shown that adherence to HAART is a multi-faceted phenomenon, which involves both behavioural and psychological features. Therefore, the results obtained so far, though promising, have not yet unambiguously identified the factors that could predict non-adherence. Since any support for strengthening the adherence should take into account the HIV+ patients' perception of both their state of health and their relational style, this study tried to identify some psychological characteristics involved in the adherence phenomenon. A self-administered battery of tests including the Attachment Style Questionnaire (ASQ) and the Multidimensional Health Locus of Control Form-C (MHLC-C) was administered to an Italian sample. Results showed significant gender differences between non-adherent and adherent subjects. Specifically, the psychological profile of non-adherent males seemed focused less on relational aspects and perceived relevance of physicians and of 'significant other people', whilst that of non-adherent females seemed more 'relationship-oriented'. This study means to encourage clinicians to plan specific, gender-focused support for enhancing adherence.

The usefulness of the Multidimensional Health Locus of Control Form C (MHLC-C) for HIV+ subjects: an Italian study.

In the last few years, highly active antiretroviral therapy (HAART) has resulted in a remarkable decrease in HIV-related morbidity and mortality. This "new deal" encouraged clinical research in investigating patients' manifest behaviours and their beliefs regarding their health status, which likely influence not only their treatment-linked behaviours but also their quality of life. Locus of control has been shown to be a construct that can predict and explain health-related behaviours. The Multidimensional Health Locus of Control Form C (MHLC-C) is a condition-specific locus of control scale that can be easily adapted for use with any medical or health-related condition. With the aim to enhance the knowledge about the HIV+ patients' point of view of their complex health condition, this study preliminarily investigated the psychometrics properties of the MHLC-C Italian version and its generalizability across samples defined both by being adherent or not and by gender. Two more samples of chronic patients (Cardiac Surgery and Cancer) were enrolled to better characterize the HIV+ patient's MHLC-C profile. The results showed the validity, reliability and generalizability of the 4-factor structure of MHLC-C. More interestingly, HIV+ subjects revealed a peculiar pattern of beliefs regarding their health condition that clinicians should take into account when managing patients' complex bio-psychosocial condition.

Psychological stress in nurses' relationships with HIV-infected patients: the risk of burnout syndrome.

To assess the role played by psychological stress and sociodemographic factors as predictors of burnout in nurses, we administered the AIDS Impact Scale (AIS) and the Maslach Burnout Inventory (MBI) to nurses in the AIDS field. The sample was composed of 410 nurses from 19 departments for the treatment of infectious diseases. In these subjects we observed a low level of burnout in the MBI, but a small proportion had a high level of burnout We did not find significant associations between sociodemographic variables and the MBI scales. We found significant correlations between the MBI and three AIS scales that specifically assessed the emotional involvement of nurses in their relationships with patients. The results suggest that an empathic involved relationship seems to be protective towards burnout rather than a frustrating involved relationship. Moreover nurses tolerate stress better if they receive supportive social rewards. We found that the impact of working with HIV-infected patients causes psychological stress (measured with the AIS), but it is a weak predictor of burnout (measured with the MBI). The results indicated the incompatibility between the relational/defensive model of the AIS and the environmental/work performance model of the MBI.

An assessment of self-esteem in HIV-positive patients.

The objective of this research is to assess how self-esteem levels differ in HIV-infected subjects in three different risk behaviours: drug addicts, homosexuals, heterosexuals. The sample (n = 104) consisted of: drug addicts (n = 46); homosexual (n = 26); heterosexuals (n = 32). The Rosenberg Self-Esteem Scale (RSES) and the Eysenck Personality Inventory (EPI) were used. A covariance analysis was used to assess the effect of the different personality traits on the 'self-esteem variable' and to eliminate the variance caused by the personality variables. Bonferroni's T-test was used to assess which group contributed to confute the hypothesis of equivalence between the RSES means of the groups. A significant association between the HIV-infection risk behaviour and the level of self-esteem was shown; this association was assessed by eliminating the effect of personality traits. The risk behaviour as well as the personality traits were both indicative of the level of self-esteem. The assessment of each group revealed that the drug addicts had a relatively lower self-esteem level (mean = 35.251) than the homosexuals (mean = 38.698) and the heterosexuals (mean = 38.227). In conclusion the RSES enables clinicians to identify subjects with low levels of self-esteem who need to be psychologically assessed within a vast population of HIV-infected patients.