Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 76
Filtrar
1.
HIV Med ; 16(10): 628-34, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26238151

RESUMO

OBJECTIVES: The primary objective was to evaluate the improvement in neuropsychiatric symptoms attributed to an antiretroviral drug after that drug was substituted with nevirapine. The secondary objective was to evaluate the impact on patient adherence and quality of life. METHODS: A prospective, observational study was carried out that included patients with HIV-1 plasma suppression for whom an antiretroviral drug was substituted with nevirapine because of central nervous system (CNS) side effects, a Pittsburgh Sleep Quality Index (PSQI) score > 5 or a Hospital Anxiety and Depression Scale (HADS) score ≥ 10, and who had not initiated psychoactive drug treatment during the prior 6 weeks. Evaluations were carried out at baseline and 1 and 3 months after the switch using the PSQI, HADS, Epworth Sleepiness Scale, Medical Outcomes Study-Short Form 30 items (MOS-SF-30) and Simplified Medication Adherence Questionnaire (SMAQ). RESULTS: A total of 129 patients were included in the study. The drug substituted was mainly efavirenz (89.9%), and reasons for the switch included sleep disturbances (75.2%), anxiety (65.1%), depression (38.7%), attention disturbances (31%), and other reasons (31%), with a mean of 2.4 neuropsychiatric disturbances per patient. A statistically significant improvement was observed in all the tests evaluating neuropsychiatric symptoms and adherence at 1 and 3 months. The CD4 lymphocyte count remained stable (P = 0.096). Three (2.3%) patients had a detectable plasma HIV-1 RNA at the end of the study. Nine patients (6.9%) withdrew because of nevirapine-related toxicity (rash in seven patients and hypertransaminasaemia in two patients, none of which were > grade 2). CONCLUSIONS: The switch to nevirapine from a drug causing neuropsychiatric disturbances (primarily efavirenz) in subjects with virological suppression was effective in resolving those disturbances, with an improvement in all the parameters studied. This led to better adherence to treatment and quality of life, with no detrimental effect on their immunological and virological control.


Assuntos
Fármacos Anti-HIV/efeitos adversos , Benzoxazinas/efeitos adversos , Doenças do Sistema Nervoso Central/induzido quimicamente , Substituição de Medicamentos , Infecções por HIV/tratamento farmacológico , Transtornos Mentais/induzido quimicamente , Nevirapina/uso terapêutico , Inibidores da Transcriptase Reversa/efeitos adversos , Inibidores da Transcriptase Reversa/uso terapêutico , Adulto , Idoso , Alcinos , Fármacos Anti-HIV/uso terapêutico , Contagem de Linfócito CD4 , Ciclopropanos , Feminino , Humanos , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida
2.
J Antimicrob Chemother ; 70(8): 2330-6, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25921514

RESUMO

OBJECTIVES: Ex vivo analysis of mitochondrial function may reveal HIV progression and the impact of ART. We propose a mitochondrial and apoptotic in vitro model using Jurkat T cells incubated with plasma. The objectives of this study were to evaluate mitochondrial and apoptotic lesions in this model in relation to HIV progression, and to assess the effect of >1 year of standard non-thymidine-containing therapy. METHODS: This was a cross-sectional comparison among three age- and gender-matched groups (n = 19 × 3): healthy non-HIV-infected participants, HIV-infected long-term non-progressors (LTNPs) and standard antiretroviral-naive chronically infected patients [standard progressors (Sps)], longitudinally evaluated before (Sp1) and after (Sp2) >1 year of efavirenz + tenofovir + emtricitabine therapy. We analysed mitochondrial DNA content by RT-PCR, mitochondrial function by spectrophotometry, mitochondrial protein synthesis by western blot analysis, mitochondrial dynamics by western blot analysis (MFN2), apoptotic transition pore formation by western blot analysis (VDAC-1) and mitochondrial membrane potential and annexin V/propidium iodide fluorescence by flow cytometry. RESULTS: There was a decreasing non-significant trend towards lower mitochondrial parameters for HIV-infected values with respect to uninfected control reference values. HIV progression (LTNP versus Sp1) was associated with decreased mitochondrial genetic, functional and translational parameters, which partially recovered after treatment intervention (Sp2). Mitochondrial fusion showed a trend to decrease non-significantly in Sp patients compared with LTNP patients, especially after therapy. All apoptotic parameters showed a trend to increase in Sp1 with respect to LTNP, followed by recovery in Sp2. CONCLUSIONS: We proposed an in vitro model for mitochondrial and apoptotic assessment to test the effects of HIV infection and its therapy, resembling in vivo conditions. This model could be useful for clinical research purposes.


Assuntos
Antirretrovirais/administração & dosagem , Antirretrovirais/efeitos adversos , Apoptose , Infecções por HIV/tratamento farmacológico , Infecções por HIV/patologia , Mitocôndrias/efeitos dos fármacos , Adulto , Estudos Transversais , Progressão da Doença , Feminino , Infecções por HIV/virologia , HIV-1/isolamento & purificação , Humanos , Células Jurkat , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Mitocôndrias/fisiologia
3.
Curr HIV Res ; 10(8): 688-93, 2012 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-23092198

RESUMO

BACKGROUND & AIMS: Considering the disadvantages of liver biopsy, alternative noninvasive methods have been sought to assess the stage of liver fibrosis. The aim of this study is to determine the prevalence of different stages of chronic liver disease using noninvasive methods (transition elastography (Fibroscan®) and Forns and AST-to-platelet ratio index-APRI-indexes) in HCV/HIV-coinfected patients. MATERIALS & METHODS: An observational, cross-sectional, multicenter study conducted between September 2007 and May 2008. The study enrolled coinfected patients who had a transient elastography performed in the year of the study and/or biochemical markers (Forns/APRI indexes) to assess the stage of liver fibrosis. RESULTS: A total of 109 patients were finally enrolled. Mean elastography velocity was 15.3 kPa, and mean APRI and Forns indexes were 1.4 and 6.1, respectively. According to transient elastography: 41% had mild, 24% moderate, and 35% severe fibrosis; 35% with significant fibrosis. According to the APRI index: 29% had mild, 45% moderate, and 26% severe fibrosis; 28% with significant fibrosis. According to the Forns index: 16% had mild, 54% moderate, and 30% severe fibrosis; 30% with significant fibrosis. The Kappa concordance index between the three methods was 0.42 for fibrosis stage and 0.52 for significant fibrosis detection (p < 0.001 in both cases). CONCLUSIONS: There is concordance between the APRI and Forns indexes and elastography in the detection of different fibrosis stages and it is significant. Transient elastography agrees with these indexes in the detection of significant and severe fibrosis.


Assuntos
Coinfecção , Infecções por HIV/complicações , Hepatite C Crônica/complicações , Cirrose Hepática/patologia , Adulto , Biomarcadores/sangue , Coinfecção/sangue , Estudos Transversais , Técnicas de Imagem por Elasticidade , Feminino , Hepatite C Crônica/sangue , Humanos , Cirrose Hepática/epidemiologia , Masculino , Pessoa de Meia-Idade , Prevalência , Espanha/epidemiologia
4.
HIV Clin Trials ; 12(1): 1-8, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21388936

RESUMO

PURPOSE: To determine whether immigrant status is associated with late initiation of highly active antiretroviral treatment (HAART) and/or poor response to antiretrovirals. METHODS: GESIDA 5808 is a multicenter, retrospective cohort study (inclusion period January 2005 through December 2006) of treatment-naïve patients initiating HAART that compares HIV-infected patients who are immigrants with Spanish-born patients. A late starter (LS) was defined as any patient starting HAART with a CD4+ lymphocyte count <200 cells/µL and/or diagnosis of an AIDS-defining illness before or at the start of therapy. The primary endpoint was time to treatment failure (TTF), defined as virological failure (VF), death, opportunistic infection, treatment discontinuation/switch (D/S), or missing patient. Secondary endpoints were time to treatment failure as observed data (TTO; censoring missing patients) and time to virological failure (TVF; censoring missing patients and D/S not due to VF). RESULTS: LS accounted for 56% of the patients. Lower educational and socioeconomic level and intravenous drug use (IVDU) were associated with categorization as LS, but immigrant status was not. Cox regression analysis (hazard ratio [HR]; 95% CI) between LS and non-LS patients showed no differences in TTF (0.97; 0.78-1.20) or TTO (1.18; 0.88-1.58), although it did reveal a difference in TVF (1.97; 1.18-3.29). CD4+ lymphocyte recovery was equivalent for both LS and non-LS patients (159 vs 173). CONCLUSIONS: In our cohort, immigrant status was not shown to be related to late initiation of HAART. Although LS patients did not have a longer TTF for any reason, TVF was significantly shorter. Despite universal free access to HAART in Spain, measures to ensure early diagnosis and treatment of HIV infection are necessary.


Assuntos
Fármacos Anti-HIV/administração & dosagem , Terapia Antirretroviral de Alta Atividade/métodos , Infecções por HIV/tratamento farmacológico , Infecções por HIV/virologia , HIV/crescimento & desenvolvimento , Adulto , Estudos de Coortes , Emigrantes e Imigrantes , Feminino , Infecções por HIV/imunologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Espanha , Falha de Tratamento , Carga Viral
7.
Antiviral Res ; 85(2): 403-8, 2010 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-19941906

RESUMO

BACKGROUND: Although efavirenz and lopinavir/ritonavir(r) are both recommended antiretroviral agents in antiretroviral-naïve HIV-infected patients, there are few randomized comparisons of their efficacy and tolerability. METHODS: A multicenter and randomized study was performed including 126 antiretroviral-naïve patients, randomly assigned to efavirenz+Kivexa (n=63) or lopinavir/r+Kivexa (n=63). Efficacy endpoints were the percentage of patients with HIV-RNA < or =50 copies/mL at week 48 and CD4 recovery. Safety was assessed by comparing toxicity and discontinuations. Statistical analyses were performed on an intention-to-treat (ITT) basis (Missing=Failure). RESULTS: At week 48, 56.7% of patients in the efavirenz and 63.2% in the lopinavir/r groups showed HIV-1 RNA <50 copies/mL (P=0.770) (intention-to-treat analysis; Missing=Failure). Only 1 (1.53%) patient from each group experienced virological failure. CD4 values increased in both groups (298 cells in the efavirenz group, P=0.001; 249 cells in the lopinavir/r group, P=0.002; P=0.126 between groups). HDL-cholesterol only increased in the efavirenz group (from 39+/-12 mg/dL to 49+/-11; P=0.001). Discontinuations were more frequent in the lopinavir/r group (36.5% versus 28.5%; P=0.193), but more patients with efavirenz interrupted due to toxicity (11.1% versus 6.3%); most of them were attributed to hypersensitivity reaction. CONCLUSIONS: Similar virological efficacy was observed for efavirenz and lopinavir/r, when administered with Kivexa in antiretroviral-naïve patients, while immunological improvement was slightly superior for efavirenz. The higher rate of discontinuation due to toxicity in the efavirenz group was related to a higher incidence of hypersensitivity reaction. Nowadays, the use of the new formulation of lopinavir/r and the HLA-B*5701 genotype test before starting abacavir should improve the safety profiles of these regimens.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Benzoxazinas/uso terapêutico , Infecções por HIV/tratamento farmacológico , Pirimidinonas/uso terapêutico , Ritonavir/uso terapêutico , Adulto , Alcinos , Fármacos Anti-HIV/efeitos adversos , Benzoxazinas/efeitos adversos , Contagem de Linfócito CD4 , Ciclopropanos , Didesoxinucleosídeos , Combinação de Medicamentos , Hipersensibilidade a Drogas , Feminino , Humanos , Lamivudina/efeitos adversos , Lopinavir , Masculino , Pessoa de Meia-Idade , Pirimidinonas/efeitos adversos , RNA Viral/sangue , Ritonavir/efeitos adversos , Resultado do Tratamento , Carga Viral , Suspensão de Tratamento/estatística & dados numéricos
8.
HIV Med ; 10(9): 573-9, 2009 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-19785666

RESUMO

BACKGROUND: Reports have shown that the publication of practice guidelines does not guarantee their use in clinical practice. The objective of this study was to evaluate the agreement between antiretroviral treatments (ARTs) prescribed in clinical practice and the recommendations in published guidelines. METHODS: A retrospective cohort study was carried out in ART-naïve adults of the Spanish Asociacion Medica Vach de Estudios Multicentricos (VACH) Cohort for the period from 2003 to 2006. RESULTS: A total of 945 patients initiated ART. Of these patients, 12.3% had a CD4 cell count above 350 cells/microL. A 'nonrecommended' antiretroviral regimen was prescribed to 5.3, 5.1 and 7.8% of patients with CD4 counts <200, 200-350 and >350 cells/microL, respectively. Multivariate analyses demonstrated that only a higher viral load was associated with the selection of a combination treatment that was recommended by the guidelines. CONCLUSIONS: Most patients were prescribed initial treatments in agreement with the recommendations. Appropriate routine data collection in databases can be used to evaluate the level of antiretroviral guideline compliance. We propose that routine evaluations of the guidelines must be part of quality assessment to improve medical care.


Assuntos
Antirretrovirais/uso terapêutico , Fidelidade a Diretrizes/normas , Infecções por HIV/tratamento farmacológico , HIV-1 , Guias de Prática Clínica como Assunto/normas , Padrões de Prática Médica , Adulto , Idoso , Contagem de Linfócito CD4 , Feminino , Infecções por HIV/imunologia , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Estudos Retrospectivos , Espanha , Fatores de Tempo , Carga Viral
9.
Emergencias (St. Vicenç dels Horts) ; 21(3): 183-185, ene.-dic. 2009. tab
Artigo em Espanhol | IBECS | ID: ibc-97135

RESUMO

Objetivo: Conocer si la gestión del transporte sanitario en ambulancia desde el servicio de urgencias hospitalario disminuye el tiempo de espera y las reclamaciones por la demora del mismo. Método: Análisis prospectivo y comparativo de dos periodos de tiempo, uno sin gestión del transporte sanitario (SGTS) en los meses de octubre y noviembre de 2007, y otro con gestión (CGTS) desde el servicio de urgencias en los meses de diciembre de2007 y enero de 2008. Se recogieron el número de transportes realizados, el tiempo de demora y las quejas recibidas en los dos periodos. Se excluyeron los transportes urgentes de pacientes en ambulancia a otros centros hospitalarios. Resultados: Durante el periodo SGTS se realizaron 544 evacuaciones y en el periodo CGTS 720. La demora media en el periodo SGTS fue de 2 horas y 4 minutos (espera máxima: 8 horas) y en el CGTS fue de 1 hora y 1 minuto (espera máxima: 4 horas). Durante el periodo SGTS se realizaron 5 quejas por escrito y 64 quejas orales en relación al transporte sanitario, mientras que en el CGTS no hubo quejas por escrito y se registraron 19 quejas orales. En este último periodo hubo el doble de transportes múltiples(2 pacientes en la misma ambulancia) que en el periodo SGTS. Conclusión: La gestión del transporte sanitario desde el servicio de urgencias en el periodo de estudio supuso una franca mejoría en las variables estudiadas (AU)


Objective: To determine whether hospital emergency service management of ambulance services reduces wait time and complaints about delayed transport. Methods: A prospective study comparing 2 periods of time, one in which ambulance service was not managed by the hospital emergency department (October and November 2007) and another in which the department did manage the ambulance service (December 2007 and January 2008). The number of transfers, transport time, and complaints received in the 2 periods were analyzed. Ambulance trips taking patients to other hospitals were excluded from the analysis. Results: During the first period, patients from 544 emergency calls were brought in; in the second period, the service responded to 720 calls for emergency transport. In the first study period, the mean wait time was 2 hours and 4 minutes(maximum wait time, 8 hours). In the second period, the mean wait time was 1 hour and 1 minute (maximum, 4hours). Five complaints about emergency transport (9 written, 64 verbal) were lodged in the first period. The second period saw no written complaints and 19 verbal complaints. Twice the number of double transports (2 patients in the same ambulance) took place in the second period with in the first period. Conclusion: Emergency department management of ambulance services brought considerable improvement in the variables studied (AU)


Assuntos
Humanos , Transporte de Pacientes/organização & administração , Serviços Médicos de Emergência/organização & administração , Ambulâncias/organização & administração , Melhoria de Qualidade/tendências , Estudos Prospectivos , Fatores de Tempo
10.
HIV Clin Trials ; 9(2): 83-90, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-18474493

RESUMO

PURPOSE: To evaluate the satisfaction with self-injected enfuvirtide (ENF) and the clinical outcome of HIV-infected patients without very advanced disease. METHOD: ESPPE is a multicenter observational study that included 103 evaluated patients showing baseline characteristics predictive of positive outcome: CD4 >100 cells/mm3, viral load (VL) <100,000 copies/mL, previous treatment with a maximum of 10 antiretroviral drugs, and concomitant use of 2 active drugs. By using validated surveys, patients were questioned 6 months after the prescription of ENF about their quality of life (QoL) and acceptance of self-injections and adherence to the treatment. RESULTS: At 6 months, the mean CD4 increase was 121 cells/mm3 (p < .05) and 65% (intent-to-treat, ENF stopped=failure) had VL <50 copies/mL (p < .001). Fourteen patients discontinued the treatment, mostly due to intolerance (6). The majority (>89%) assessed all items relating QoL as "excellent," "very good," or "good." The treatment satisfaction index on a visual analog scale scored a median of 8.1 out of 10; when participants were asked about the interference of injections on their daily activities, 87% answered "never" or "only sometimes." CONCLUSION: Effectiveness and patients' perception about ENF remain good when ENF was used in patients without very advanced disease. QoL was not impaired after ENF use.


Assuntos
Proteína gp41 do Envelope de HIV/uso terapêutico , Inibidores da Fusão de HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , Satisfação do Paciente/estatística & dados numéricos , Fragmentos de Peptídeos/uso terapêutico , Adulto , Contagem de Linfócito CD4 , Estudos Transversais , Enfuvirtida , Feminino , Infecções por HIV/imunologia , Infecções por HIV/psicologia , Infecções por HIV/virologia , Humanos , Masculino , Pessoa de Meia-Idade , Cooperação do Paciente/estatística & dados numéricos , Qualidade de Vida , Inquéritos e Questionários , Resultado do Tratamento , Carga Viral
11.
Rev Clin Esp ; 207(9): 427-32, 2007 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-17915162

RESUMO

BACKGROUND: The use of HAART combining 2 nucleoside analogues reverse transcriptase inhibitors (NRTIs) plus one protease inhibitor (PI) or 2 NRTIs + 1 non-nucleoside reverse transcriptase inhibitor (NNRTI) has shown comparable efficacy. The study was designed to compare long term (2 years) effectiveness of two antiretroviral (ARV) treatment strategies in patients not previously treated: starting with a nelfinavir based HAART switching to nevirapine in case of failure or side effects or the reverse sequence. METHODS: This multicenter, randomized, open label clinical trial enrolled ARV-naïve HIV patients with CD4 counts below 500 cells/mm3. They were randomly assigned to start ddI + d4T + nelfinavir (switching to ZDV + 3TC + NEV in case of failure or toxicity) (PI-NEV arm) or ddI + d4T + nevirapine, switching to ZDV + 3TC + NFV in case of failure or toxicity (NEV-PI arm). The primary study endpoint was the Kaplan-Meier estimates of the time to failure after switching to second regimen if necessary (considering failure as two consecutive plasma HIV-1 RNA determinations above 200 copies/mL, death, a new category C event or toxicity leading to treatment discontinuation of the second regimen) after a minimum follow-up of two years. RESULTS: A total of 137 patients were evaluable (67 and 70 in the PI-NEV and NEV-PI arms respectively). Baseline characteristics did not differ among groups. Kaplan-Meier estimates of time to failure did not show differences between the two arms neither in the on-treatment (OT) analysis (log rank test, p = 0.81) nor in the intent-to-treat (ITT) analysis (p = 0.58). At 24 months, the estimated proportion of patients free of failure were 72% and 66% respectively in the PI-NEV and NEV-PI arms OT analysis (p = 0.54) and 73% and 64% in the PI-NEV and NEV-PI arms in the ITT analysis (p = 0.49). The difference in the median in CD4+ lymphocyte count at 24 months was not significantly different in the two groups: 393 and 307 CD4 cells/mm3 in the PI-NEV and NEV-PI arms respectively (p = 0.167). The incidence of adverse events (AEs) in the two arms was very similar: 50 (75%) in the PI-NEV and 54 (70%) in the NEV-PI group, as it was for grade 3-4 AEs leading to drug switching. CONCLUSION: At two years both treatments strategies (PI-NEV vs NEV-PI) had a high and comparable efficacy and were generally well tolerated.


Assuntos
Terapia Antirretroviral de Alta Atividade/métodos , Infecções por HIV/tratamento farmacológico , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Tempo
12.
Rev. clín. esp. (Ed. impr.) ; 207(9): 427-432, oct. 2007. ilus, tab
Artigo em Es | IBECS | ID: ibc-057747

RESUMO

Background. The use of HAART combining 2 nucleoside analogues reverse transcriptase inhibitors (NRTIs) plus one protease inhibitor (PI) or 2 NRTIs + 1 non-nucleoside reverse transcriptase inhibitor (NNRTI) has shown comparable efficacy. The study was designed to compare long term (2 years) effectiveness of two antiretroviral (ARV) treatment strategies in patients not previously treated: starting with a nelfinavir based HAART switching to nevirapine in case of failure or side effects or the reverse sequence. Methods. This multicenter, randomized, open label clinical trial enrolled ARV-naïve HIV patients with CD4 counts below 500 cells/mm³. They were randomly assigned to start ddI + d4T + nelfinavir (switching to ZDV + 3TC + NEV in case of failure or toxicity) (PI-NEV arm) or ddI + d4T + nevirapine, switching to ZDV + 3TC + NFV in case of failure or toxicity (NEV-PI arm). The primary study endpoint was the Kaplan-Meier estimates of the time to failure after switching to second regimen if necessary (considering failure as two consecutive plasma HIV-1 RNA determinations above 200 copies/mL, death, a new category C event or toxicity leading to treatment discontinuation of the second regimen) after a minimum follow-up of two years. Results. A total of 137 patients were evaluable (67 and 70 in the PI-NEV and NEV-PI arms respectively). Baseline characteristics did not differ among groups. Kaplan-Meier estimates of time to failure did not show differences between the two arms neither in the on-treatment (OT) analysis (log rank test, p = 0.81) nor in the intent-to-treat (ITT) analysis (p = 0.58). At 24 months, the estimated proportion of patients free of failure were 72% and 66% respectively in the PI-NEV and NEV-PI arms OT analysis (p = 0.54) and 73% and 64% in the PI-NEV and NEV-PI arms in the ITT analysis (p = 0.49). The difference in the median in CD4+ lymphocyte count at 24 months was not significantly different in the two groups: 393 and 307 CD4 cells/mm3 in the PI-NEV and NEV-PI arms respectively (p = 0.167). The incidence of adverse events (AEs) in the two arms was very similar: 50 (75%) in the PI-NEV and 54 (70%) in the NEV-PI group, as it was for grade 3-4 AEs leading to drug switching. Conclusion. At two years both treatments strategies (PI-NEV vs NEV-PI) had a high and comparable efficacy and were generally well tolerated (AU)


Introducción. El uso del tratamiento antirretroviral de alta eficacia (TARGA) que combina 2 análogos de nucleósidos (NRTI) más un inhibidor de proteasas (IP) o 2 NRTI más 1 no-análogo de nucleósido (NNRTI) ha demostrado tener eficacia comparable. Este estudio fue diseñado para comparar la efectividad a largo plazo (2 años) de 2 estrategias de tratamiento antirretroviral (ARV) en pacientes no tratados previamente: empezando con un TARGA utilizando nelfinavir (NFV) y cambiando a nevirapina (NEV) en caso de fallo o de efectos adversos o viceversa. Métodos. Éste es un ensayo clínico, abierto, randomizado y multicéntrico que incluye pacientes infectados por el virus de la inmunodeficiencia humana (VIH) que nunca han recibido ARV y con menos de 500 CD4. Los pacientes fueron aleatorizados a recibir ddI mas d4T mas NFV (cambiando a ZDV más 3TC más NEV en caso de fallo o toxicidad; brazo PI-NEV) o ddI más d4T más NEV (cambiando a ZDV más 3TC más NFV en caso de fallo o toxicidad; brazo NEV-PI). El objetivo primario del estudio fue el tiempo estimado hasta el fracaso después de cambiar al segundo régimen terapéutico cuando fue necesario (considerando fracaso como 2 determinaciones de carga viral del VIH por encima de 200 copias/ml, muerte, un nuevo evento de la categoría C o toxicidad que lleve a la discontinuación del segundo régimen) después de un mínimo de seguimiento de 2 años. Resultados. Se evaluaron un total de 137 pacientes (67 y 70 en el brazo PI-NEV y NEV-PI, respectivamente). Las características basales de los pacientes fueron similares en ambos grupos. El tiempo estimado hasta el fracaso del tratamiento mediante las curvas de Kaplan-Meier no mostraron diferencias entre los 2 brazos de tratamiento ni en el análisis por tratamiento (OT) (p = 0,81) ni en el análisis por intención de tratar (p = 0,58). A los 24 meses, la proporción estimada de pacientes libres de fracaso fue del 72 y el 66%, respectivamente, en el brazo de PI-NEV y NEV-PI en el análisis OT (p = 0,54) y del 73 y el 64% en el PI-NEV y NEV-PI en el análisis ITT (p = 0,49). La diferencia en la mediana de linfocitos CD4 a los 24 meses no fue significativamente diferente entre ambos grupos: 393 y 307 CD4 células/mm3 en el grupo PI-NEV y NEV-PI, respectivamente (p = 0,167). La aparición de efectos adversos del tratamiento fue muy similar: 50 (75%) en el grupo PI-NEV y 54 (70%) en el grupo NEV-PI, así como los efectos adversos de grado 3-4 que llevaron a la discontinuación del tratamiento. Conclusión. Las estrategias de tratamiento PI-NEV frente a NEV-PI tienen una eficacia alta y comparable a los 2 años de seguimiento y en general fueron bien toleradas (AU)


Assuntos
Humanos , Terapia Antirretroviral de Alta Atividade , Infecções por HIV/tratamento farmacológico , Fatores de Tempo
13.
HIV Clin Trials ; 5(3): 132-9, 2004.
Artigo em Inglês | MEDLINE | ID: mdl-15248137

RESUMO

PURPOSE: The aim of the study was to assess differences in health-related quality of life (HRQoL) in HIV-infected naive patients treated with two HAART regimens at 12 months. METHOD: The MOS-HIV questionnaire was used to measure HRQoL in a subgroup of 127 patients included in the COMBINE study, which was an open-label, randomized, multicenter study comparing zidovudine (ZDV) and lamivudine (3TC) plus nelfinavir (NFV) or nevirapine (NVP) regimens in HIV-infected naive patients. 63 patients were included in the ZDV/3TC/NFV arm and 64 in the ZDV/3TC/NVP arm. RESULTS: No statistically significant differences were observed at baseline in demographic and clinical variables and HRQoL scores between treatment groups, except that the proportion of homosexual men was higher in the ZDV/3TC/NVP arm. There were no statistically significant differences in HRQoL scores between arms at 12 months and over time; only ZDV/3TC/NVP patients showed statistically significant improvement in Physical Health Summary score (p <.01) and a trend toward a better profile in Mental Health Summary score (p =.07). Overall, patients who were treated with ZDV/3TC/NVP showed greater changes in physical dimensions and patients who were treated with ZDV/3TC/NFV showed greater changes in mental health. CONCLUSION: Differences in HRQoL between study groups at 1 year follow-up were not detected. Nevertheless, a trend toward improvement was observed in summary health scores in ZDV/3TC/NVP-treated patients.


Assuntos
Fármacos Anti-HIV/administração & dosagem , Infecções por HIV/tratamento farmacológico , Infecções por HIV/psicologia , Qualidade de Vida , Adulto , Idoso , Fármacos Anti-HIV/efeitos adversos , Quimioterapia Combinada , Feminino , Humanos , Lamivudina/administração & dosagem , Lamivudina/efeitos adversos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Nelfinavir/administração & dosagem , Nelfinavir/efeitos adversos , Nevirapina/administração & dosagem , Nevirapina/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Espanha , Inquéritos e Questionários , Zidovudina/administração & dosagem , Zidovudina/efeitos adversos
14.
AIDS ; 15(13): 1643-51, 2001 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-11546938

RESUMO

OBJECTIVES: The management of HIV infection has greatly improved during recent years essentially because of the appearance of new antiretroviral drugs. Highly active antiretroviral therapy (HAART) has achieved important reductions of viraemia and significant recoveries of CD4(+) cell counts in HIV-infected patients. Nonetheless, cases of HIV-infected individuals experiencing lipodystrophy (LD) are being increasingly reported. The purpose of this work was to analyse whether the presence of mitochondrial abnormalities is a frequent feature in LD, since we previously detected mitochondrial abnormalities in an HIV-patient. The second main objective was to study whether LD could be associated with a specific drug. DESIGN: Seven HIV patients presenting LD and five HIV non-LD controls participated in the study. LD patients met the following criteria: (1) LD was their only clinical abnormality, (2) LD was clinically relevant, (3) compliance with antiretroviral treatment was higher than 90% and (4) patients did not have personal or familial history suggestive of mitochondrial disease or neuromuscular disorder. METHODS: Histological stainings, histo-enzymatic reactions, enzymatic and respiratory activities of mitochondrial respiratory chain complexes, and mitochondrial DNA (mtDNA) depletion and rearrangements were examined on muscle mitochondria. RESULTS: Structural muscle abnormalities, mitochondrial respiratory chain dysfunction or mtDNA deletions were detected in all HIV lipodystrophic patients. CONCLUSIONS: The mitochondrial abnormalities found suggest that mitochondrial dysfunction could play a role in the development of antiretroviral therapy-related lipodystrophy.


Assuntos
Terapia Antirretroviral de Alta Atividade/efeitos adversos , Infecções por HIV/tratamento farmacológico , Lipodistrofia/induzido quimicamente , Mitocôndrias Musculares/metabolismo , Mitocôndrias Musculares/ultraestrutura , Adulto , Idoso , DNA Mitocondrial/genética , DNA Mitocondrial/metabolismo , Feminino , Deleção de Genes , Infecções por HIV/complicações , HIV-1 , Humanos , Lipodistrofia/metabolismo , Lipodistrofia/patologia , Masculino , Pessoa de Meia-Idade , Músculo Esquelético/metabolismo , Músculo Esquelético/ultraestrutura
15.
Med Clin (Barc) ; 115(4): 132-4, 2000 Jun 24.
Artigo em Espanhol | MEDLINE | ID: mdl-10996883

RESUMO

OBJECTIVE: To evaluate the changes in the urgent visits made by HIV+ patients after generalisation of the protease inhibitors. PATIENTS AND METHODS: Comparison on the visits made during a period prior to and after use of protease inhibitor. RESULTS: After the generalisation of the protease inhibitors the visits rate decreased, the motives for consulting with the physician and complementary examinations changed, invasive therapeutic procedures, admissions from urgencies and death rates decreased. CONCLUSIONS: The protease inhibitors have changed the urgent visits profile of HIV+ patients.


Assuntos
Serviço Hospitalar de Emergência/estatística & dados numéricos , Infecções por HIV/tratamento farmacológico , Inibidores da Protease de HIV/uso terapêutico , Síndrome da Imunodeficiência Adquirida/tratamento farmacológico , Síndrome da Imunodeficiência Adquirida/etiologia , Adulto , Feminino , Infecções por HIV/etiologia , Soropositividade para HIV/tratamento farmacológico , Heterossexualidade , Homossexualidade , Humanos , Masculino , Fatores de Risco , Abuso de Substâncias por Via Intravenosa/complicações
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...