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Objective: It has recently been highlighted how a short healthy life-style program (LSP) can improve the functional outcomes of older people admitted to a Long-Term Care (LTC) facility. Although it is known that life-style medicine-based interventions can exert anti-aging effects through the modulation of oxidative stress and mitochondrial function, the mechanisms underlying the aforementioned effects have not been clarified, yet. For this reason, in this study, the outcomes were focused on the investigation of the possible mechanisms underlying the benefits of a short LSP in older people. This was achieved by examining circulating markers of oxidative stress and immunosenescence, such as Tymosin β (Tβ4), before and after LSP and the effects of plasma of older people undergone or not LSP on endothelial cells. Methods: Fifty-four older people were divided into two groups (n = 27 each): subjects undergoing LSP and subjects not undergoing LSP (control). The LSP consisted of a combination of caloric restriction, physical activity, and psychological intervention and lasted 3 months. Plasma samples were taken before (T0) and after LSP (T1) and were used to measure thiobarbituric acid reactive substances (TBARS), 8-hydroxy-2-deoxyguanosine (8OHdG), 8-Isoprostanes (IsoP), glutathione (GSH), superoxide dismutase (SOD) activity and Tβ4. In addition, plasma was used to stimulate human vascular endothelial cells (HUVEC), which were examined for cell viability, mitochondrial membrane potential, reactive oxygen species (ROS) and mitochondrial ROS (MitoROS) release. Results: At T1, in LSP group we did not detect the increase of plasma TBARS and IsoP, which was observed in control. Also, plasma levels of 8OHdG were lower in LSP group vs control. In addition, LSP group only showed an increase of plasma GSH and SOD activity. Moreover, plasma levels of Tβ4 were more preserved in LSP group. Finally, at T1, in HUVEC treated with plasma from LSP group only we found an increase of the mitochondrial membrane potential and a reduction of ROS and MitoROS release in comparison with T0. Conclusions: The results of this study showed that a short LSP in older persons exerts antiaging effects by modulating oxidative stress also at cellular levels. Implications of those findings could be related to both prognostic and therapeutic strategies, which could be pursued as antiaging methods.

The accuracy of reaction theories used to extract properties of exotic nuclei from scattering experiments is often unknown or not quantified, but of utmost importance when, e.g., constraining the equation of state of asymmetric nuclear matter from observables as the neutron-skin thickness. In order to test the Glauber multiple-scattering model, the total interaction cross section of Image 1 on carbon targets was measured at initial beam energies of 400, 550, 650, 800, and 1000 MeV/nucleon. The measurements were performed during the first experiment of the newly constructed R3B (Reaction with Relativistic Radioactive Beams) experiment after the start of FAIR Phase-0 at the GSI/FAIR facility with beam energies of 400, 550, 650, 800, and 1000 MeV/nucleon. The combination of the large-acceptance dipole magnet GLAD and a newly designed and highly efficient Time-of-Flight detector enabled a precise transmission measurement with several target thicknesses for each initial beam energy with an experimental uncertainty of ±0.4%. A comparison with the Glauber model revealed a discrepancy of around 3.1% at higher beam energies, which will serve as a crucial baseline for the model-dependent uncertainty in future fragmentation experiments.

Abstract Background in COVID-19 acute respiratory failure, the effects of CPAP and FiO2 on respiratory effort and lung stress are unclear. We hypothesize that, in the compliant lungs of early Sars-CoV-2 pneumonia, the application of positive pressure through Helmet-CPAP may not decrease respiratory effort, and rather worsen lung stress and oxygenation when compared to higher FiO2 delivered via oxygen masks. Methods In this single-center (S.Luigi Gonzaga University-Hospital, Turin, Italy), randomized, crossover study, we included patients receiving Helmet-CPAP for early (

Syphilis is a re-emerging sexually transmitted infection. According to the definition, latent syphilis is characterized by seroreactivity without clinical manifestations. Here, we reported an atypical case of syphilis in a patient with HIV naïve to the antiretroviral treatment characterized by mucocutaneous relapse that occurred in the late latent stage. The patient reported his last sexual intercourse about 18 months ago and had self-healing genital and palmoplantar lesions more than 1 year before the presentation. He denied any other types of sexual relationship. He presented with mucocutaneous scattered lesions on his face, neck, palms, soles, penis, and scrotum. He was compliant with arthralgias, myalgias, asthenia, new onset stypsis, and mild anorectal pain. Testing for Syphilis and HIV returned positive. Opportunistic infections were excluded, and antiretroviral therapy with a bictegravir-based regimen was started. Syphilis was treated successfully with three doses of 2.4 million units of benzathine penicillin.

IntroductionResidents of long-term care facilities (LTCFs) are a population at high risk of developing severe healthcare associated infections (HAIs). In the assessment of HAIs in acute-care hospitals, selection bias can occur due to cases being over-represented: patients developing HAIs usually have longer lengths of stays compared to controls, and therefore have an increased probability of being sampled in PPS, leading to an overestimation of HAI prevalence. Our hypothesis was that in LTCFs, the opposite may occur: residents developing HAIs either may have a greater chance of being transferred to acute-care facilities or of dying, and therefore could be under-represented in PPS, leading to an underestimation of HAI prevalence. Our aim was to test this hypothesis by comparing HAI rates obtained through longitudinal and cross-sectional studies.MethodsResults from two studies conducted simultaneously in four LTCFs in Italy were compared: a longitudinal study promoted by the European Centre for Disease Prevention and Control (ECDC, HALT4 longitudinal study, H4LS), and a PPS. Prevalence was estimated from the PPS and converted into incidence per year using an adapted version of the Rhame and Sudderth formula proposed by the ECDC. Differences between incidence rates calculated from the PPS results and obtained from H4LS were investigated using the Byar method for rate ratio (RR).ResultsOn the day of the PPS, HAI prevalence was 1.47% (95% confidence interval, CI 0.38-3.97), whereas the H4LS incidence rate was 3.53 per 1000 patient-days (PDs, 95% CI 2.99-4.08). Conversion of prevalence rates obtained through the PPS into incidence using the ECDC formula resulted in a rate of 0.86 per 1000 PDs (95% CI 0-2.68). Comparing the two rates, a RR of 0.24 (95% CI 0.03-2.03, p 0.1649) was found.ConclusionsThis study did not find significant differences between HAI incidence estimates obtained from a longitudinal study and through conversion from PPS data. Results of this study support the validity of the ECDC method.

Abstract Background Insights around second victims (SV) and patient safety has been growing over time. An overview of the available evidence is lacking. This review aims to describe (i) the impact a patient safety incident can have and (ii) how healthcare professionals can be supported in the aftermath of a patient safety incident. Methods A literature search in Medline, EMBASE and CINAHL was performed between 1 and 2010 and 26 November 2020 with studies on SV as inclusion criteria. To be included in this review the studies must include healthcare professionals involved in the aftermath of a patient safety incident. Results In total 104 studies were included. SVs can suffer from both psychosocial (negative and positive), professional and physical reactions. Support can be provided at five levels. The first level is prevention (on individual and organizational level) referring to measures taken before a patient safety incident happens. The other four levels focus on providing support in the aftermath of a patient safety incident, such as self-care of individuals and/or team, support by peers and triage, structured support by an expert in the field (professional support) and structured clinical support. Conclusion The impact of a patient safety incident on healthcare professionals is broad and diverse. Support programs should be organized at five levels, starting with preventive actions followed by self-care, support by peers, structured professional support and clinical support. This multilevel approach can now be translated in different countries, networks and organizations based on their own culture, support history, structure and legal context. Next to this, they should also include the stage of recovery in which the healthcare professional is located in.

OBJECTIVE: Switching from oral anti-retroviral therapy (ART) to intramuscular administration of Cabotegravir-Rilpivirine (CAB+RPV) has been observed to decrease the number of pills that patients need to take, enhance patient satisfaction, and promote better adherence to treatment. Clinical trials have reported not only the virological and immunological effectiveness of these intramuscular medications but have also assessed their safety and patient satisfaction. This transition eliminates the challenges related to patient adherence and compliance with daily oral regimens. PATIENTS AND METHODS: Our observational study included 14 people living with HIV (PLWH) who were under medical care at the “Gaetano Martino” University Hospital in Messina, Italy. These individuals were virologically suppressed and had been adherent to ART for at least 6 months. Importantly, they did not have documented or suspected resistance mutations to Cabotegravir + Rilpivirine (CAB+RPV). Data were collected at different time points: at the beginning of the study, one month after the lead-in phase with oral CAB+RPV, and one month after the first and second injections of CAB+RPV. Additionally, we routinely measured CD4+, CD8+, CD4+/CD8+ ratio, HIV-RNA plasma viral load, and clinical chemistry parameters. Statistical analysis was performed with Jamovi 2.0 for MacOS. Patient treatment satisfaction was assessed through a questionnaire, where we formulated and administered a series of questions to our patients to gauge their satisfaction with the intramuscular administration of these long-acting medications. Specifically, we asked them a simple question to determine whether they were satisfied or dissatisfied with the new method of administering CAB+RPV. RESULTS: In our study, we enrolled 14 individuals living with HIV (PLWH), predominantly males (92.9%), with a median age of 36 years (IQR: 30.25-39.75). Of these participants, 85.7% had transitioned from an integrase strand transfer inhibitor (INSTI)-based regimen, 7.1% from a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen, and 7.1% from a protease inhibitor (PI)-based regimen. Notably, HIV-RNA remained undetectable throughout the assessment period. Following the first intramuscular (IM) injection, 78.5% reported moderate to severe pain, decreasing to 57.1% after the second injection. While not statistically significant, we observed a positive trend in CD4+ percentage (p=0.641) and CD4/CD8 ratio (p=0.368), with a non-significant decrease in CD4+ T-cell count (p=0.882). The transition to IM CAB+RPV did not significantly impact low-density lipoprotein cholesterol (LDLc) levels (p=0.417). When questioned about satisfaction with the new treatment regimen, 71.4% of PLWH expressed contentment with the injectable regimen, while 21.4% chose not to respond. CONCLUSIONS: People living with HIV (PLWH) who were on long-acting ART (LA-ART) with CAB+RPV expressed satisfaction with their new treatment regimen, and viral load remained undetectable in all cases. Pain, as reported in clinical trials, emerged as the primary side effect. Our real-life experience affirmed the virological and immunological effectiveness, safety, and patient satisfaction associated with long-acting ART using CAB+RPV.

Objective: The Italian National Action Plan to contrast AMR identified among its objectives the development and implementation of a national Healthcare-Associated Infection (HAI) surveillance system based on European Centre for Disease Prevention and Control (ECDC) indications, through point prevalence surveys (PPS) of HAIs and antibiotic use in acute-care hospitals and long-term care facilities (LTCFs). We aimed to assess feasibility and appropriateness of proposed tools for a national surveillance system of HAIs and antibiotic use in LTCFs. Study design: Point prevalence survey. Methods: A pilot PPS was conducted between May–June 2022, among 15 LTCFs of 7 Italian regions. Data were collected in a single day in each LTCF, at the LTCF, ward, and resident levels, using a web-based data collection tool developed ad hoc. Data collector teams of each facility were invited to complete a questionnaire investigating opinions on the proposed tools. Results: Among 1025 included residents, the prevalence of residents with at least one HAI was 2.5% (95% CI 1.7%-3.7%) considering all HAIs and 2.2% (95% CI 1.3%–3%) without considering SARS-CoV-2 infections. The prevalence of antimicrobial use was 3% (95% CI 0.2%–4.3%). Overall, most respondents were satisfied with the web-based software, training and protocol, even though some difficulties were reported. Conclusions: A national surveillance network was established, which will facilitate future surveillance efforts. Further studies are necessary to evaluate the impact of the pandemic on HAI transmission and antibiotic use in LTCFs.

Abstract Background In Italy, the State Regions Conference on 1st August 2019 approved the Guidelines for Short-Stay Observation (SSO). At the beginning of 2022, the main Scientific Societies of the pediatric hospital emergency-urgency area launched a national survey to identify the extent to which these national guidelines had been adopted in the emergency rooms and pediatric wards of the Italian Regions. Methods A survey has been widespread, among Pediatric Wards and Pediatric Emergency Departments (EDs), using both a paper questionnaire and a link to a database on Google Drive, for those who preferred to fill it directly online. Those who did not spontaneously answer, where directly contacted, via email and/or through a phone call and invited to participate. The data collected have been: age of managed children, presence of triage, presence of Sub-intensive Care Unit and Intensive Care Unit and special questions about Pediatric SSO, availability of training courses for workers, number of ED access in the last 4 years. Results This survey is still ongoing, without a definite deadline, so we presented the preliminary data. Currently, 8/20 Regions have not yet adopted the Guidelines. Till 02 January 2023, data from 253 hospitals were collected. There are currently 180/253 active Pediatric SSO (71.03% of the Hospitals). There are not active SSO in 33.27% of first level ED, in 19.35% of second level ED and in 33.66% of General Hospitals with Pediatric Wards. Active SSO are located mainly (75.97%) within Pediatric Wards. At the moment, the survey has been completed in 16 Regions: in the 8 Regions which are using guidelines, pediatric SSOs are active in all the second level ED (compared to 60.87% of the other 8 regions), in the 91.66% of first level ED (compared to the 33.3%), and in the 97.1% of General Hospitals (compared to 33.3%), with a statistically significance (p

Orthostatic tremor is a rare movement disorder characterized by a sensation of unsteadiness and leg tremor while standing. It has been hypothesized that the disorder is attributable to dysregulation of a central oscillatory network in the brain. This putative network includes primary motor cortex, supplementary motor area, cerebellum, thalamus, and pontine tegmentum. We studied this brain network by recording resting-state functional MRI data from individuals with orthostatic tremor. For each participant, we measured resting-state functional connectivity using a seed-based approach. Regions of interest included were components of the putative central oscillatory network and a primary motor thumb region (identified via transcranial magnetic stimulation). A non-central oscillatory network region of interest—posterior cingulate cortex—was included for comparative analysis of a well-characterized intrinsic network, the default mode network. Demographic information, medical history, and tremor characteristics were collected to test associations with functional connectivity. For normative context, data from the 1000 Functional Connectomes Project were analyzed using an identical approach. We observed that tremor and demographic variables were correlated with functional connectivity of central oscillatory network components. Furthermore, relative to healthy comparison participants, patients with orthostatic tremor exhibited qualitatively different patterns of cerebellar resting state functional connectivity. Our study enhances the current understanding of brain network differences related to orthostatic tremor and is consistent with a hypothesized selective decoupling of cerebellum. Additionally, associations observed between functional connectivity and factors including medical history and tremor features may suggest targets for treatment of orthostatic tremor.

In this contribution the connection between the Dipolar degree of freedom excited in Heavy Ion Collisions through pre-equilibrium dipolar modes and the Isospin-equilibration processes is discussed. The connection leads to the definition of a new observable the so called “dipolar signal”, able to describe the equilibration process in the momentum space related to the final fragmentation produced by the HIC. Preliminary results on this observable measured on the system 48Ca +27 Al at 40 MeV/nucleon and corresponding to different degrees of dissipation/centrality are presented. The beam was accelerated through the Superconductor Cyclotron at the Laboratori Nazionali del Sud di Catania (Italy) and fragments were detected and identified with the 4π multi-detector CHIMERA.

Cutaneous melanoma (CM) is traditionally considered one of the most “immunogenic” tumors, eliciting a high immune response. However, despite the presence of tumor-infiltrating lymphocytes (TILs), melanoma cells use strategies to suppress antitumor immunity and avoid being eliminated by immune surveillance. The PD-1 (programmed death-1)/PD-L1 (programmed death-ligand 1) axis is a well-known immune escape system adopted by neoplastic cells. Therefore, immunotherapy with PD-1 and PD-L1 inhibitors is quickly becoming the main treatment approach for metastatic melanoma patients. However, the clinical utility of PD-L1 expression assessment in CM is controversial, and the interpretation of PD-L1 scores in clinical practice is still a matter of debate. Nonetheless, the recent literature data show that by adopting specific PD-L1 assessment methods in melanoma samples, a correlation between the expression of such a biomarker and a positive response to PD-1-based immunotherapy can be seen. Our review aims to describe the state-of-the-art knowledge regarding the prognostic and predictive role of PD-L1 expression in CM while also referring to possible biological explanations for the variability in its expressions and related treatment responses.

An investigation of the influence of the isospin (N/Z ratio) on the thermometric characteristics, in the reactions 78Kr+40Ca and 86Kr+48Ca at 10 AMeV is presented. The experiment was performed at the INFN Laboratori Nazionali del Sud in Catania by using the beams delivered by the Superconductive Cyclotron and the 4π multidetector CHIMERA. The isospin effects on the decay modes of the two produced composite systems and on the competition between statistical and dynamical break-up of the projectile have been studied. The thermal evaporation from both compound nucleus (CN) and Quasi-Projectile Like Fragment (PLF) has been investigated by extracting the temperature with two different thermometric methods, namely the slope thermometer, with the alpha particles as probe, and the double isotope yields ratio thermometer. The results of the analysis suggest the influence of the N/Z ratio on the system (CN or PLF) temperature, regardless of the nature of the method used for its determination.

HIV/AIDS is considered a risk factor for increased mortality due to COVID-19. For this reason, it is essential to include this population in vaccination campaigns. Studies found that antibodies are lower in HIV+ patients than in healthy individuals. The aim of this study was to assess the immune response in a cohort of people living with HIV/AIDS (PLWH) vaccinated with COVID-19 vaccination in order to evaluate the role played by the HIV infection in the efficacy of this vaccine. We carried out a cross-sectional study in the period April-September 2021, involving a cohort of PLWH and a cohort of HIV-uninfected people as the control group. The efficacy of vaccination was high in both groups despite a slight and not significant difference between them. However, important differences were found according to the intensity of the immune response. Specifically, while in the HIV+ group almost a quarter of people had a low response, it is important to remark that the control group had only a high or intermediate response after vaccination. Our results suggest the high efficacy of the mRNA COVID-19 vaccine in PLWH and the importance to vaccinate against COVID-19 in these patients in order to increase their protection.

Thyroid diseases (TDs) and thyroid asymptomatic dysfunctions (TADs) are correlated with Human Immunodeficiency virus (HIV) infection and Acquired ImmunoDeficiency Syndrome (AIDS) as well as many endocrine dysfunctions and dysregulation of hormonal axes. To date, available studies on People Living With HIV (PLWH) affected by thyroid diseases and asymptomatic dysfunctions are few and rather controversial. The purpose of the present non-systematic literature review is to recap the current knowledge on the main features of thyroid dysfunctions and disorders in PLWH. Large cohort studies are needed for a better comprehension of the impact, evolution and treatment of thyroid pathologies in the HIV-infected population.

A zoonosis is an infectious disease that has jumped from a non-human animal to humans. Some zoonoses are very common in the Mediterranean area and endemic in specific regions, so they represent an important problem for public health. Human Immunodeficiency Virus (HIV) is a virus that has originated as a zoonosis and is now diffused globally, with the most significant numbers of infected people among the infectious diseases. Since the introduction of antiretroviral therapy (ART), the history for people living with HIV (PLWH) has changed drastically, and many diseases are now no different in epidemiology and prognosis as they are in not-HIV-infected people. Still, the underlying inflammatory state that is correlated with HIV and other alterations related to the infection itself can be a risk factor when infected with other bacteria, parasites or viruses. We reviewed the literature for infection by the most common Mediterranean zoonoses, such as Campylobacter, Salmonella, Brucella, Rickettsia, Borrelia, Listeria and Echinococcus, and a possible correlation with HIV. We included Monkeypox, since the outbreak of cases is becoming a concern lately. We found that HIV may be related with alterations of the microbiome, as for campylobacteriosis, and that there are some zoonoses with a significant prevalence in PLWH, as for salmonellosis.

Introduction: There are currently no effective treatments for primary orthostatic tremor (POT). An adequate disease-specific POT severity scale is a prerequisite to conduct clinical trials and monitor disease severity in clinical practice. Recently, the English OT-10 scale has been developed for this purpose. Here we aimed to obtain a scale to measure the severity of POT in Dutch speaking individuals. Methods: An established translation, adaptation and validation approach was employed to obtain a Dutch version of the OT-10 scale. Validation was performed in a Dutch POT cohort (n = 46). Results: A Dutch OT-10 scale was obtained which showed good internal consistency (Cronbach’s alpha > 0.80), total score test–retest reliability (intraclass correlation coefficient > 0.80), and concurrent validity (Pearson correlation > 0.80). Item-to-total correlation was good (weighted kappa > 0.40) for all items, and item test–retest reliability was good (weighted kappa > 0.40) for eight out of ten items. Overall, the Dutch OT-10 scale demonstrated acceptable validity. Conclusions: We obtained and validated a Dutch version of the OT-10 scale, capturing POT severity. Next to its use in clinical practice, translation and validation of the OT-10 scale in more languages will help to find evidence-based treatments for POT.

Introduction: Orthostatic tremor (OT) is a rare neurological disorder characterized by a sensation of instability while standing. Very few clinical signs have been described for OT to date. Finding other symptoms and signs could prove valuable for this hard-to-recognized disease. Methods: This protocol is part of the University of Nebraska Medical Center Orthostatic Tremor longitudinal study. It was noted that OT patients flex their toes and sometimes the foot arch while standing (Plantar Grasp). They reported doing this to “grab” the floor and improve stability. This paper analyses the diagnostic test characteristics of the patient-self-reported Plantar Grasp, a new sign in OT. Results: There were 34 OT patients (88% females), and 20 controls (65% females). Eighty-eight percent of patients with OT reported the plantar grasp sign and none of the controls. The Plantar Grasp Sign was found to be very sensitive (88%), and extremely specific (100%) in our cohort. Non-weighted Negative Likelihood Ratio (NLR) was 0.12. And the 3% prevalence-weighted NLR was so low that the negative post-test probability was close to zero. Conclusion: Due to its high sensitivity, specificity, and ideal likelihood ratio, we propose that the Plantar Grasp sign could be considered to screen patients with possible OT. Further studies are needed to determine the specificity of this sign in OT versus other balance disorders.

Proper detection of neutrons and charged particles is motivated by the recent efforts to construct new facilities for radioactive ion beams (RIBs) worldwide. Detection of neutrons is an important opportunity to improve our understanding of nuclear spectroscopy and reaction dynamics, with the possibility of constraining theoretical models of the nuclear equation of state (NEoS) and investigating in-medium nuclear interactions. This topic also has important implications in the study of astrophysical objects, such as neutron stars. In this work, the state-of-the-art of Neutron Array for Correlation Studies (NArCoS), a new hodoscope for neutron and charged particles under construction in Catania (INFN), is briefly reviewed.

Kaposi sarcoma (KS) is a multifocal lympho-angioproliferative, mesenchymal low-grade tumor associated with a γ2-herpesvirus, named Kaposi sarcoma-associated virus or human herpesvirus (KSHV/HHV8). The lung is considered a usual anatomical location of KS, despite being infrequent, often in association with extensive mucocutaneous lesions and very uncommonly as an isolated event. We report a case of a pulmonary KS (pKS) in a human immunodeficiency virus (HIV) naïve patient, which was atypical due to a lack of cutaneous involvement and an absence of respiratory symptoms. The pKS was initially identified as a tumoral suspected nodular lesion and only after immunohistochemical analysis was it characterized as KS. Furthermore, the diagnosis of pKS led to the discovery of the HIV-seropositive status of the patient, previously unknown. Our report underlines the importance of considering pKS even without skin lesions and as a first manifestation of HIV infection. We also reviewed literature on the current knowledge about pKS in people living with HIV (PLWH) to underline how one of the most common HIV/acquired immunodeficiency syndrome (AIDS) associated tumors can have a challenging localization and be difficult to recognize.

Hepatocellular carcinoma (HCC) accounts for approximately 75–90% of primary liver cancers and is the sixth most common cancer and the third leading cause of cancer-related deaths worldwide. In the HIV-positive population, the risk of HCC is approximately four times higher than in the general population, with higher cancer-specific mortality than in HIV-negative patients. In most cases, HCC diagnosis is made in patients younger than the HIV-negative population and in the intermediate-advanced stage, thus limiting the therapeutic possibilities. Treatment choice in HIV-positive patients with HCC is subject to cancer staging, liver function and health status, as for HIV-negative and non-HIV-negative HCC patients. There are relatively few studies on the efficacy and safety in HIV-positive patients to date in loco-regional treatments for HCC. So far, literature shows that curative treatments such as radiofrequency ablation (RFA) have no significant differences in overall survival between HIV-positive and HIV-negative patients, as opposed to palliative treatments such as TACE, where there is a significant difference in overall survival. Although it can be assumed that the most recently discovered loco-regional therapies are applicable to HIV-positive patients with HCC in the same way as HIV-negative patients, further studies are needed to confirm this hypothesis. The purpose of our review is to evaluate these treatments, their efficacy, effectiveness, safety and their applicability to HIV-positive patients.