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Efficacy, safety and pharmacokinetic of once-daily boosted saquinavir (1500/100 mg) together with 2 nucleos(t)ide reverse transcriptase inhibitors in real life: a multicentre prospective study
Luis F López-Cortés, Pompeyo Viciana, Rosa Ruiz-Valderas, Juan Pasquau, Josefa Ruiz, Fernando Lozano, Dolores Merino, Antonio Vergara, Alberto Terrón, Luis González, Antonio Rivero, Agustin Mu?oz-Sanz
AIDS Research and Therapy , 2010, DOI: 10.1186/1742-6405-7-5
Abstract: Prospective, multicentre study in which efficacy, safety and pharmacokinetics of a regimen of once-daily SQVr 1500/100 mg plus 2 NRTIs were evaluated under routine clinical care conditions in either antiretroviral-na?ve patients or in those with no previous history of antiretroviral treatments and/or genotypic resistance tests suggesting SQV resistance. Plasma SQV trough levels were measured by HPLV-UV.Five hundred and fourteen caucasian patients were included (47.2% coinfected with hepatitis C and/or B virus; 7.8% with cirrhosis). Efficacy at 52 weeks (plasma RNA-HIV <50 copies/ml) was 67.7% (CI95: 63.6 - 71.7%) by intention-to-treat, and 92.2% (CI95: 89.8 - 94.6%) by on-treatment analysis. The reasons for failure were: dropout or loss to follow-up (18.4%), virological failure (7.8%), adverse events (3.1%), and other reasons (4.6%). The high rate of dropout may be explained by an enrollement and follow-up under routine clinical care condition, and a population with a significant number of drug users. The median SQV Cmin (n = 49) was 295 ng/ml (range, 53-2172). The only variable associated with virological failure in the multivariate analysis was adherence (OR: 3.36; CI95, 1.51-7.46, p = 0.003).Our results suggests that SQVr (1500/100 mg) once-daily plus 2 NRTIs is an effective regimen, without severe clinical adverse events or hepatotoxicity, scarce lipid changes, and no interactions with methadone. All these factors and its once-daily administration suggest this regimen as an appropriate option in patients with no SQV resistance-associated mutations.Saquinavir was the first protease inhibitor (PI) commercially available for the treatment of patients with HIV infection. Its oral bioavailability is markedly increased when concomitantly administered with low dose retainer, which allows for reduced dosing frequency and dosage. Ritonavir-boosted saquinavir (SQVr) at the standard dosing of 1000/100 mg twice daily has shown as effective as ritonavir-boosted-lopinavir, al
HCV Viral Decline at Week 2 of Peg-IFN-Alpha-2a/RBV Therapy as a Predictive Tool for Tailoring Treatment in HIV/HCV Genotype 1 Co-Infected Patients
Antonio Rivero-Juarez, Luis F. López-Cortés, Angela Camacho, Almudena Torres-Cornejo, Ana Gordon, Rosa Ruiz-Valderas, Julian Torre-Cisneros, Juan A. Pineda, Pompeyo Viciana, Antonio Rivero
PLOS ONE , 2014, DOI: 10.1371/journal.pone.0099468
Abstract: Background Optimizing HCV genotype 1 therapy in terms of response prediction and tailoring treatment is undoubtedly the cornerstone of treating HIV co-infected patients in clinical practice. Accordingly, our aim was to analyze the predictive value of HCV viral decline for sustained virological response (SVR), measured at a time point as early as week 2 of therapy with pegylated interferon alpha-2a plus ribavirin (Peg-IFN/RBV). Methods Previously untreated HIV/HCV genotype 1 co-infected patients were included in this study. The HCV RNA titer was measured at week 2 after starting treatment with Peg-IFN/RBV. The likelihood of reaching SVR when HCV RNA viral titers declined at week 2 was evaluated relative to predictive baseline factors. Results A total of 192 HIV/HCV genotype-1 co-infected patients were enrolled in the study and began therapy. One hundred and sixty-three patients completed a full course of Peg-IFN/RBV treatment for 2 weeks and 59 of these (36.2%) reached SVR. An HCV RNA viral load decline of ≥1.5 log IU/mL at week 2 had the maximum positive predictive value for SVR (83.3%; 95% CI: 68.5%–92.9%) and was identified as the strongest independent predictive factor for reaching SVR across all baseline predictive factors. Conclusions HCV viral decline at week 2 had a high predictive value for identifying patients with a high and low likelihood of reaching SVR using dual therapy, regardless of strong predictive baseline factors. This finding may be useful for developing a predictive tool to help tailor HCV genotype 1 therapy in HIV co-infected patients.
PROCESO DE ENTRENAMIENTO DE GRUPOS DE CODIFICADORES ESPECíFICOS ANTE UN SISTEMA MúLTIPLE DE CATEGORíAS DE ANáLISIS DEL DISCURSO EN UN GRUPO DE TRABAJO DE DOCENTES EN EDUCACIóN FíSICA. Methodology for observer training in research about Physical Activity and Sport where observation is used as the main methodology
J. Viciana
Motricidad : European Journal of Human Movement , 2010,
Abstract: En el desarrollo de este artículo exponemos el proceso llevado a cabo para formar y entrenar a codificadores de un discurso escrito, con el fin de procesar y analizar textos producto de grabaciones en audio de reuniones formativas entre profesores de Educación Secundaria Obligatoria en Educación Física (EF). Este proceso fue llevado a cabo en una investigación sobre la formación permanente del profesorado de EF, producto de una tesis doctoral presentada en 1996 en la Universidad de Granada. Por ello comenzamos explicando brevemente en qué consiste la investigación global, seguimos describiendo la complejidad que encierra el análisis de un gran volumen de información escrita como resultado del diálogo entre profesores, lo cual hace necesario entrenar a una serie de codificadores para los textos. Seguidamente explicamos el proceso de entrenamiento llevado a cabo y concluimos con las estrategias seguidas en este proceso, con el fin de aportar una herramienta de utilización por parte de otros investigadores que afronten una investigación similar. PALABRAS CLAVE: Educación Física, Formación permanente del profesorado, Análisis del discurso, Entrenamiento de codificadores. In the development of this article we expose the carried out process to form and to train coders of a written speech, with the purpose of processing and analyzing texts audio product of recordings in formation meetings between professors of Obligatory Secondary Education in Physical Education (PE). This process was carried out in an investigation on the permanent formation of the teaching staff of PE, product of a presented doctoral thesis in 1996 in the University of Granada. For that reason we began explaining briefly in what the global investigation consists, we continued describing the complexity that locks up the analysis of a great volume of information written like result of the dialogue between professors, which does necessary to train to a series of coders for texts. Next we explained the process of training carried out and concluded with the strategies followed in this process, with the purpose of contributing like a tool to other investigators. KEY WORDS: Physical Education, In-service teachers training, Analysis of speech, Coders training.
Main points of attention of Physical Education teachers in their first years of teaching practice PRINCIPALES CENTROS DE ATENCIóN DEL PROFESORADO DE EDUCACIóN FíSICA EN LOS PRIMEROS A OS DE PROFESIóN DOCENTE
J. Viciana
Motricidad : European Journal of Human Movement , 2010,
Abstract: The content of the present article summarizes from two perspective, quantitative and a other qualitative one, the centers of attention of the Physical Education’s teachers (PE), in the first years of its educational profession. The quantitative perspective, analyzes the significant differences (Statistica 4,0) between the beliefs of a group of professors studied during a formative process, centering to us in those dimensions that obtained these differences and therefore, are reason for high preoccupation by the teachers. The qualitative perspective, analyzes the speech of the teachers studied during 18 sessions of formation, through the program Analysis Qualitative Data 3,0, emphasizing the more frequent thematic categories and therefore of more appearance and preoccupation by the teachers studied during its sessions of formation. Also ilustratives maps appear, with text examples of these thematic categories to observe the different directions that take the interests from the teachers. The results show that from both perspective, a common direction of the attention centers is observed towards the learning of the students. KEY WORDS: Centers of attention, practical knowledge in PE, in-service teacher training El contenido del presente artículo resume desde dos perspectivas, una cuantitativa y otra cualitativa, los focos de atención del profesorado de Educación Física (EF), en los primeros a os de su profesión docente o formación permanente. La perspectiva cuantitativa, analiza las diferencias significativas (Statistica 4.0) entre las creencias de un grupo de profesores estudiados durante un proceso formativo, centrándonos en aquellas dimensiones que obtuvieron dichas diferencias y por tanto, son motivo de alta preocupación por el profesorado. La perspectiva cualitativa, analiza el discurso de los profesores estudiados en 18 sesiones de formación, a través del programa Analysis Qualitative Data 3.0, destacando las categorías temáticas más frecuentes y por tanto de más aparición y preocupación por el profesorado estudiado durante sus sesiones de formación. Igualmente se presentan mapas ilustrativos, con ejemplos de texto de estas categorías temáticas para observar las diferentes direcciones que toman los intereses de los profesores. Los resultados muestran que desde ambas perspectivas, se observa una dirección común de los centros de atención hacia el aprendizaje de los alumnos. PALABRAS CLAVE: Centros de atención, conocimiento práctico en EF, formación permanente
Mobilities Mobilities
César Pompeyo
Teknokultura : Revista de Cultura Digital y Movimientos Sociales , 2011,
Abstract: Urry, John (2007) Mobilities.Oxford: Polity Press. Urry, John (2007) Mobilities.Oxford: Polity Press. John Urry (1946-), profesor en la Universidad de Lancaster, es un sociólogo de sobra conocido y altamente reputado en el panorama internacional de las ciencias sociales. Su dilatada carrera, aparentemente dispersa y diversificada, ha seguido senderos bastante bien definidos dejando tras de sí un catálogo extenso de obras sociológicas de primer nivel. Sus primeros trabajos se centraban en el campo de la teoría social y la filosofía de las ciencias sociales o de la sociología del poder [...]
Clinical Outcome of HIV-Infected Patients with Sustained Virologic Response to Antiretroviral Therapy: Long-Term Follow-Up of a Multicenter Cohort
Félix Gutierrez, Sergio Padilla, Mar Masiá, José A. Iribarren, Santiago Moreno, Pompeyo Viciana, Leopoldo Mu?oz, José L. Gómez Sirvent, Francesc Vidal, José López-Aldeguer, José R. Blanco, Manuel Leal, María Angeles Rodríguez-Arenas, Santiago Perez Hoyos
PLOS ONE , 2006, DOI: 10.1371/journal.pone.0000089
Abstract: Background Limited information exists on long-term prognosis of patients with sustained virologic response to antiretroviral therapy. We aimed to assess predictors of unfavorable clinical outcome in patients who maintain viral suppression with HAART. Methods Using data collected from ten clinic-based cohorts in Spain, we selected all antiretroviral-naive adults who initiated HAART and maintained plasma HIV-1 RNA levels <500 copies/mL throughout follow-up. Factors associated with disease progression were determined by Cox proportional-hazards models. Results Of 2,613 patients who started HAART, 757 fulfilled the inclusion criteria. 61% of them initiated a protease inhibitor-based HAART regimen, 29.7% a nonnucleoside reverse-transcriptase inhibitor-based regimen, and 7.8% a triple-nucleoside regimen. During 2,556 person-years of follow-up, 22 (2.9%) patients died (mortality rate 0.86 per 100 person-years), and 40 (5.3%) died or developed a new AIDS-defining event. The most common causes of death were neoplasias and liver failure. Mortality was independently associated with a CD4-T cell response <50 cells/L after 12 months of HAART (adjusted hazard ratio [AHR], 4.26 [95% confidence interval {CI}, 1.68–10.83]; P = .002), and age at initiation of HAART (AHR, 1.06 per year; 95% CI, 1.02–1.09; P = .001). Initial antiretroviral regimen chosen was not associated with different risk of clinical progression. Conclusions Patients with sustained virologic response on HAART have a low mortality rate over time. Long-term outcome of these patients is driven by immunologic response at the end of the first year of therapy and age at the time of HAART initiation, but not by the initial antiretroviral regimen selected.
Influence of IL28B Polymorphisms on Response to a Lower-Than-Standard Dose peg-IFN-α 2a for Genotype 3 Chronic Hepatitis C in HIV-Coinfected Patients
Luis F. López-Cortés, Rosa Ruiz-Valderas, Luis Jimenez-Jimenez, María F. González-Escribano, Almudena Torres-Cornejo, Rosario Mata, Antonio Rivero, Juan A. Pineda, Manuel Marquez-Solero, Pompeyo Viciana, on behalf of Grupo para el Estudio de las Hepatitis Víricas (HEPAVIR) de la Sociedad Andaluza de Enfermedades Infecciosas
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0028115
Abstract: Background Data on which to base definitive recommendations on the doses and duration of therapy for genotype 3 HCV/HIV-coinfected patients are scarce. We evaluated the efficacy of a lower peginterferon-α 2a dose and a shorter duration of therapy than the current standard of care in genotype 3 HCV/HIV-coinfected patients. Methods and Findings Pilot, open-label, single arm clinical trial which involved 58 Caucasian HCV/HIV-coinfected patients who received weekly 135 μg peginterferon-α 2a plus ribavirin 400 mg twice daily during 20 weeks after attaining undetectable viremia. The relationships between baseline patient-related variables, including IL28B genotype, plasma HCV-RNA, ribavirin dose/kg, peginterferon-α 2a and ribavirin levels with virological responses were analyzed. Only 4 patients showed lack of response and 5 patients dropped out due to adverse events related to the study medication. Overall, sustained virologic response (SVR) rates were 58.3% by intention-to-treat and 71.4% by per protocol analysis, respectively. Among patients with rapid virologic response (RVR), SVR and relapses rates were 92.6% and 7.4%, respectively. No relationships were observed between viral responses and ribavirin dose/kg, peginterferon-α 2a concentrations, ribavirin levels or rs129679860 genotype. Conclusions Weekly 135 μg pegIFN-α 2a could be as effective as the standard 180 μg dose, with a very low incidence of severe adverse events. A 24-week treatment duration appears to be appropriate in patients achieving RVR, but extending treatment up to just 20 weeks beyond negativization of viremia is associated with a high relapse rate in those patients not achieving RVR. There was no influence of IL28B genotype on the virological responses. Trial Registration: ClinicalTrials.gov NCT00553930
Eligibility for and outcome of treatment of latent tuberculosis infection in a cohort of HIV-infected people in Spain
Asuncion Diaz, Mercedes Diez, Maria Bleda, Mikel Aldamiz, Miguel Camafort, Xabier Camino, Concepcion Cepeda, Asuncion Costa, Oscar Ferrero, Paloma Geijo, Jose Iribarren, Santiago Moreno, Maria Moreno, Pablo Labarga, Javier Pinilla, Joseba Portu, Federico Pulido, Carmen Rosa, Juan Santamaría, Mauricio Telenti, Luis Trapiella, Monica Trastoy, Pompeyo Viciana
BMC Infectious Diseases , 2010, DOI: 10.1186/1471-2334-10-267
Abstract: Subjects were prospectively identified between 2000 and 2003 at ten HIV hospital-based clinics in Spain. Data were obtained from clinical records. Associations were measured using the odds ratio (OR) and its 95% confidence interval (95% CI).A total of 1242 subjects were recruited and 846 (68.1%) were evaluated for TLTBI. Of these, 181 (21.4%) were eligible for TLTBI either because they were tuberculin skin test (TST) positive (121) or because their TST was negative/unknown but they were known contacts of a TB case or had impaired immunity (60). Of the patients eligible for TLTBI, 122 (67.4%) initiated TLTBI: 99 (81.1%) were treated with isoniazid for 6, 9 or 12 months; and 23 (18.9%) with short-course regimens including rifampin plus isoniazid and/or pyrazinamide. In total, 70 patients (57.4%) completed treatment, 39 (32.0%) defaulted, 7 (5.7%) interrupted treatment due to adverse effects, 2 developed TB, 2 died, and 2 moved away. Treatment completion was associated with having acquired HIV infection through heterosexual sex as compared to intravenous drug use (OR:4.6; 95% CI:1.4-14.7) and with having taken rifampin and pyrazinamide for 2 months as compared to isoniazid for 9 months (OR:8.3; 95% CI:2.7-24.9).A minority of HIV-infected patients eligible for TLTBI actually starts and completes a course of treatment. Obstacles to successful implementation of this intervention need to be addressed.In Spain, there is an extensive overlap between the epidemiology of human immunodeficiency (HIV) and Mycobacterium tuberculosis (M. tuberculosis) infections [1]. The introduction of highly active antiretroviral treatment (HAART) has led to a reduced incidence of tuberculosis (TB) among HIV positive people, but the risk of developing TB remains much higher among this group [2] than among those without HIV infection. Thus, as suggested by studies performed in both high and low prevalence areas [3-5], treatment of latent tuberculosis infection (TLTBI) should be used in combinatio
Prevalence and resistance mutations of non-B HIV-1 subtypes among immigrants in Southern Spain along the decade 2000-2010
Beatriz de Felipe, Pilar Pérez-Romero, María Abad-Fernández, Felipe Fernandez-Cuenca, Francisco J Martinez-Fernandez, Mónica Trastoy, Rosario Mata, Luis F López-Cortés, Manuel Leal, Pompeyo Viciana, Alejandro Vallejo
Virology Journal , 2011, DOI: 10.1186/1743-422x-8-416
Abstract: Complete protease and first 220 codons of the reverse transcriptase coding regions were amplified and sequenced by population sequencing. HIV-1 subtypes were determined using Stanford University Drug Resistance Database, and phylogenetic analysis was performed comparing multiple reported sequences. Drug resistance mutations were defined according to the International AIDS Society-USA.From 2000 to 2010 a total of 1,089 newly diagnosed HIV-1-infected patients were enrolled in our cohort. Of these, 121 were immigrants, of which 98 had ethical approval and informed consent to include in our study. Twenty-nine immigrants (29/98, 29.6%) were infected with non-B subtypes, of which 15/29 (51.7%) were CRF02-AG, mostly from Sub-Saharan Africa, and 2/29 (6.9%) were CRF01-AE from Eastern Europe. A, C, F, J and G subtypes from Eastern Europe, Central-South America and Sub-Saharan Africa were also present. Some others harboured recombinant forms CRF02-AG/CRF01-AE, CRF2-AG/G and F/B, B/C, and K/G, in PR and RT-coding regions. Patients infected with non-B subtypes showed a high frequency of minor protease inhibitor resistance mutations, M36I, L63P, and K20R/I. Only one patient, CRF02_AG, showed major resistance mutation L90M. Major RT inhibitor resistance mutations K70R and A98G were present in one patient with subtype G, L100I in one patient with CRF01_AE, and K103N in another patient with CRF01_AE. Three patients had other mutations such as V118I, E138A and V90I.The circulation of non-B subtypes has significantly increased in Southern Spain during the last decade, with 29.6% prevalence, in association with demographic changes among immigrants. This could be an issue in the treatment and management of these patients. Resistance mutations have been detected in these patients with a prevalence of 7% among treatment-na?ve patients compared with the 21% detected among patients under HAART or during treatment interruption.Human immunodeficiency virus type 1 (HIV-1) is the major pathoge
Claves de la evolución demográfica en el cambio de milenio
Solsona,Montse; Viciana,Francisco;
Gaceta Sanitaria , 2004, DOI: 10.1590/S0213-91112004000700004
Abstract: this article describes the main features of the dynamics of demographic change in the population of spain during the twentieth century, emphasizing the most recent developments: population ageing, the establishment of a very low fertility regime and the increasing importance of foreign immigration as well as the impact which all these have on the composition of households. those aspects most directly related to the provision of health and social services is discussed, such as the impact of increased life expectancy on the incidence of illness and handicap in the population, the role of foreign immigration in providing personal services within the family and the health implications of the new model of delayed fertility. finally, the health implications of population projections for the next 50 years are discussed.
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