Juan Luis Gómez-Sirvent

Hospital Universitario de Canarias, San Cristóbal de La Laguna, Canary Islands, Spain

Are you Juan Luis Gómez-Sirvent?

Claim your profile

Publications (36)109.58 Total impact

  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: To present clinical experience with a regimen including abacavir/lamivudine + darunavir/ritonavir in a cohort of HIV-1-infected patients. A retrospective, multicentre cohort study, including all consecutive adult HIV-1-infected patients who started abacavir/lamivudine + darunavir/ritonavir from April 2008 to December 2010 and had at least one follow-up visit. The primary endpoint was HIV-1 viral load (VL) <40 copies/mL at week 48. One hundred and eighty-three patients (42 naive and 141 experienced) from 19 hospitals in Spain were studied. The median follow-up was 26.7 (0.5-58.6) months, 79.8% were men, the median age was 47.1 (21.4-80.5) years, 26.2% had AIDS and 38.8% were positive for hepatitis C virus. At baseline, the median CD4 count was 246 cells/mm(3) in naive patients and 393 cells/mm(3) in experienced patients and the median VL was 4.80 and <1.59 log copies/mL, respectively. At week 48, 81.8% of naive patients and 84.2% of experienced patients receiving the regimen reached a VL <40 copies/mL, whereas at 96 weeks this occurred in 90.5% and 92.8%, respectively. CD4 cell count increases at 48 and 96 weeks were +176.5 and +283.5 cells/mm(3) in naive patients and +74.9 and +93 cells/mm(3) in experienced patients, respectively. Overall, 86 (47%) patients discontinued the study regimen, in many cases possibly related to non-medical reasons, such as drug switches to reduce cost or changes in address due to economic constraints. Three patients died of causes unrelated to therapy and 19 (10.4%) discontinued the regimen due to adverse events. In our cohort, abacavir/lamivudine + darunavir/ritonavir was safe, well tolerated and achieved high rates of virological suppression. In a proportion of patients, discontinuation of this effective regimen was possibly due to non-medical reasons.
    Journal of Antimicrobial Chemotherapy 05/2014; · 5.34 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Purpose: In the last decade the prevalence of HIV-infected patients≥50 years of age has increased. FTC/TDF is nowadays one of the cornerstones of cART in naïve patients, generally considered safe and well tolerated; nevertheless there is a continuous debate about the renal safety of TDF, due to the report of cases linking this treatment with renal failure and tubular dysfunction. In addition, there is a well-recognized age-related decline in renal function. Our aim was to describe the impact of cART regimen (FTC/TDF vs. others) on renal function of subjects who start cART at≥50 years old. Methods: National, retrospective cohort analysis of HIV-infected patients>50 y at the time they began the first cART (Jan 1, 2006 - Dec 31, 2009). Patients were selected in a proportion 2:1 to FTC/TDF versus other NRTI regimens (no TDF). For this analysis we excluded subjects taking potentially nephrotoxic drugs at baseline. We compared the impact of FTC/TDF vs. no-TDF regimens (main groups) on renal function by means of the changes, during the first 12 months of treatment, in glomerular filtration rate estimated by the CKD-EPI formula, and by the analysis of time to renal deterioration during the complete follow up (defined as progression to an EPI-CKD value<60 mL/min/1.73 m2 in subjects with baseline values>60). We also compared these outcomes among FTC/TDF users, according to the third agent: PI vs. NNRTI, and lopinavir/r vs. efavirenz. Results: We included 125 patients, median age: 54.8 y, 82% males, median CD4 count 235 cells/µl, median viral load 4.7 log, follow up: median 19 months, max: 66 months. Of them, 82 started with FTC/TDF and 43 with other NRTIs (no TDF). During the follow-up 13/125 patients taking FTC/TDF (11%) presented with renal deterioration. The Cox regression model including age, sex, transmission category, baseline CD4 count and viral load, FTC/TDF use, PI/NNRTI use, and LPVr/EFV use showed a hazard ratio for renal deterioration of 4.13 (95% CI 0.92, 18.5) for LPV/r users. The table shows the evolution of glomerular filtration rate, and proportion and risk of renal deterioration. Conclusion: In subjects starting cART after 50 years of age, we have not found significant changes in glomerular filtration rate associated with the use of FTC/TDF-based regimens. Overall, the risk of renal deterioration was 4.1 times higher for LPV/r users (almost statistically significant). Among FTC/TDF users, this risk was 8 times higher for LPV/r as compared to EFV.
    Journal of the International AIDS Society 11/2012; 15(6):18312. · 3.94 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Purpose of the study: Very scarce information has been published to date with the combination of ABC/3TC/NVP but it is currently being used in clinical practice in many centers in Spain. Our aim was to present the clinical experience with this regimen in a cohort of adult HIV-infected pts. Methods: Retrospective, multicenter, cohort study. Consecutive adult HIV-infected ARV-experienced pts, HLA-B*5701-negative, who started ABC/3TC/NVP between 2005-2010, with at least one follow-up visit, were included. Demographic, clinical and laboratory variables were assessed at baseline, month 1, and every 3-4 months thereafter. The primary end point was HIV-1 viral load (VL) <40 c/mL at 48 weeks. Data were analyzed by intent-to-treat (ITT) (non-completer=failure) and on treatment (OT). Summary of results: 227 pts were included and followed up for a median of 30 (0.5-76) months. 75% male, 47 (24-83) years, 21% AIDS, 13% HCV+, baseline CD4 570 (32-1404) cells/µL and VL undetectable in 90% with a median of <1.59 (<1.59-5.1) log. Most pts were receiving NVP (63%), ABC (25%) or both (4%) in the previous regimen. ABC/3TC/NVP was initiated due to toxicity (42%), simplification (35%) or other reasons (22%) including to reduce drug cost. After 48 weeks, VL was <40 c/mL in 82% (ITT) and 94% (OT), and in 94% (OT) after 96 weeks. CD4 increased +63 (p<0.001) and +77 (p<0.001) cells/µL after 48 and 96 weeks, respectively. One or more drugs of the regimen were discontinued in 18% of pts during follow up: toxicity (7%), virologic failure (3%), lost to follow-up (3%), unrelated death (0.4%) or other reasons (4%). No significant differences were observed in ALT, AST, or triglyceride changes during follow up. A significant increase of 7%, 10% and 14% was observed in total cholesterol, LDLc and HDLc, and a significant decrease in TC/HDL ratio (-5%, p=0.004) after 96 weeks, respectively. Conclusions: In this particular cohort of ARV-experienced pts previously receiving NVP or ABC, a combination of ABC/3TC/NVP was safe and mantained virologic suppression in the vast majority of pts, with rates similar to other switch strategies. A favourable lipid profile was observed after 96 weeks of follow up.
    Journal of the International AIDS Society 11/2012; 15(6):18343. · 3.94 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The major antiretroviral guidelines recommend starting ART in patients>50 y of age, regardless of CD4 cell count. However, no references to the preferred cART for these patients have been described. The combination FTC/TDF is one of the cornerstones of combined antiretroviral therapy (cART) in naïve patients. We studied the persistence of coformulated FTC/TDF in this scenario. National, retrospective cohort analysis of HIV-infected patients>50 y at the time they began the first cART regimen (January 1, 2006 - December 31, 2009). Patients were selected in a proportion 2:1 to FTC/TDF vs. other NRTI regimens (no-TDF). We compared the persistence of treatment in FTC/TDF users vs. no-TDF (main groups). Among TDF users, we compared the persistence in PI vs. NNRTI users and in lopinavir/r vs. efavirenz users. Persistence was defined as the duration of the initial treatment; we analyzed time to any change or discontinuation according to initial regimen. We included 161 patients: median age: 54.6 y, 83% males, median CD4 count 191 cells/μl, median viral load 4.7 log, follow up: median 19 months, max 48 months. Of them, 112 started with FTC/TDF (53 with PIs, 57 with NNRTIs); and 49 with other NRTIs (no-TDF) (22 with PI, 23 NNRTI). During the follow-up period 79 patients (49%) modified their treatment, with statistically significant differences among groups, as shown in Table 1.*Adjusted by age, sex, transmission category and baseline CD4 count and viral load.In our study (antiretroviral-naïve patients>50 y), the persistence of FTC/TDF regimens was significantly higher than other NRTI regimens. According to the third agent, there was a trend to a higher persistence with NNRTI vs. PI. This reaches statistical significance when we compare EFV vs. LPV/r. In the absence of randomized clinical trials, our data may contribute to a better understanding on how cART works in this ageing population, which is progressively increasing.
    Journal of the International AIDS Society 11/2012; 15(6):18292. · 3.94 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: BACKGROUND AND AIMS: Most studies have shown that patients with chronic hepatitis C virus (HCV) infection are affected by osteoporosis. However, liver function impairment and deranged nutrition may both play a role in the bone alterations observed. In some works no osteoporosis was found, and some cases of osteosclerosis have been reported. The aim of the study is to assess bone alterations in treatment-naïve, well-nourished HCV patients, in order to discern whether or not HCV infection causes osteoporosis. METHODS: Whole-body bone densitometry and assessment of T-score at lumbar spine and hip were performed to 40 patients and 40 age- and sex-matched controls, with a Lunar Prodigy Advance (General Electric, Piscataway, NJ, USA). All the patients underwent liver biopsy. Nutritional evaluation was performed by subjective nutritional assessment, body mass index (BMI), and densitometric assessment of total lean mass and total fat mass. Serum osteocalcin, osteoprotegerin, RANKL, PTH, crosslaps, vitamin D3, testosterone, IGF-1, and estradiol were determined. RESULTS: Patients did not show differences in total bone mineral density (BMD) or T-score with controls. On the contrary, about a third of them showed positive T scores. Patients showed lower IGF-1, vitamin D3 and testosterone, but higher telopeptide levels, and a trend to higher osteoprotegerin levels. Multivariate analyses disclosed that age, sex, and total lean mass were the only parameters independently related with BMD. CONCLUSIONS: Therefore, chronic HCV infection in well nourished patients with preserved liver function does not cause osteoporosis.
    European Journal of Internal Medicine 09/2012; · 2.30 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: OBJECTIVE:: To study trends in overall deaths and cause-specific deaths stratified by HCV serostatus in a cohort of combined antiretroviral (cART)-naïve HIV-infected patients in Spain METHODS:: We analyzed data from 1997 to 2008 in 2 calendar periods: 1997-2003 and 2004-2008. Deaths were ascertained through cohort reporting and a cross-match with the Spanish National Death Index. We used Poisson regression to model mortality rates and risk factors. RESULTS:: We analyzed 5,974 HIV-positive cART-naïve patients: 2,471 (1,497 HCV+) in the period 1997-03, and 3,503 (689 HCV+) in the period 2004-08. A total of 232 deaths (158 during the first period, and 74 during the second period) were detected during 19,416 person-years (PYs) of follow-up; the death rate was 12.9/1,000 PYs. Crude overall death rates (95% CI) were 16.5 (14.2-19.1) in 1997-2003 and 8.5 (6.7-10.6) in 2004-08. The incidence rate ratio (IRR) (95%CI) in 2004-08 taking 1997-03 as a reference was 0.51 (0.39-0.67). When we stratified by HCV serostatus, the overall death IRR (95% CI) taking 1997-03 as reference was 0.52 (0.32-0.85) for HCV-negative patients and 1.27 (0.90-1.79) for HCV-positive patients. When we considered cause-specific deaths (liver-related, AIDS-related, and non-liver-related/non-AIDS-related), findings were similar to those for overall-deaths. CONCLUSIONS:: Taking the first years of the cART era as a reference, we observed a decrease in overall and cause-specific mortality. This decrease was only observed in HCV-negative patients.
    AIDS (London, England) 07/2012; · 4.91 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: To evaluate long-term outcomes in patients maintaining a nevirapine (NVP)-based regimen. Retrospective, multicenter, cohort study including patients currently receiving an NVP regimen that had been started at least 5 years previously. Demographic, clinical, and analytical variables were recorded. Median follow-up was 8.9 (5.7-11.3) years. Baseline characteristics: 74% men, 47 years old, 36% drug users, 40% AIDS, 40% HCV+, 51.4% detectable HIV-1 viral load, CD4 count 395 (4-1,421)/μL, 19% CD4 < 200/μL, 27% ALT grade 1-2, 36% AST grade 1-2. Thirty percent ART-naive, 83%received NVP associated with 2 nucleoside analogues during the study period, and 17% a protease inhibitor. A significant improvement was observed in general health status markers, including hemoglobin, platelets, and albumin, regardless of HCV coinfection. CD4 cell gain was +218 and +322/μL after 6 and 9 years, respectively (+321 and +391 in naive patients). Triglycerides significantly decreased in pretreated patients, whereas the percentage of patients with HDLc < 1.03 mmol/L and LDL-c > 3.37 mmol/L significantly decreased in a subsample with available values. A significant decrease in transaminases, alkaline phosphatase, and Fib4 score was observed, mainly in HCV+ and ARV-naive patients. In patients who tolerate NVP therapy, (even those with HCV coinfection), long term benefits may be significant in terms of a progressive improvement in general health status markers and CD4 response, a favorable lipid profile, and good liver tolerability.
    Current HIV research 06/2012; 10(6):513-20. · 1.98 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: BACKGROUND: The aim of this study was to investigate the incidence and risk factors for the development of AIDS-defining cancers (ADCs); and to investigate the effect of making different assumptions on the definition of incident cases. METHODS: A multicentre cohort study was designed. Poisson regression was used to assess incidence and risk factors. To account for misclassification, incident cases were defined using lag-times of 0, 14 and 30 days after enrolment. RESULTS: A total of 6393 HIV-positive subjects were included in the study. The incidences of ADCs changed as the lag periods were varied from 0 to 30 days. Different risk factors emerged as the definition of incident cases was changed. For a lag time of 0, the risk of Kaposi sarcoma [KS] and non-Hodgkin lymphoma [NHL] increased at CD4 counts <200/ml. HAART was associated with lower risk of NHL and KS. Men who had sex with men had a higher risk of KS. KS and NHL were not associated with viral load, gender, or hepatitis B or C. The results were similar for a lag-time of 14 and 30 days; however, hepatitis C was significantly associated with NHL. CONCLUSIONS: This analysis shows the importance of the definition of incident cases in cohort studies. Alternative definitions gave different incidence estimates, and may have implications for the analysis of risk factors.
    Enfermedades Infecciosas y Microbiología Clínica 05/2012; · 1.48 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The presence of resistance mutations in patients failing tipranavir or darunavir was examined at the national drug resistance database of the Spanish AIDS Research Network. Although mutations emerging during tipranavir and darunavir failures differed considerably, cross-resistance was found in up to half of the patients tested. Interestingly, mutation 54L, which is associated with tipranavir hypersusceptibility, was selected in half of the darunavir failures. Thus, resistance testing seems mandatory to ensure the benefit of the sequential use of these drugs.
    Antimicrobial Agents and Chemotherapy 07/2010; 54(7):3018-20. · 4.57 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: A proportion of HIV-patients does not normally restore their CD4 counts despite virological response to HAART. Those whose CD4 counts persistently remain closed to the critical threshold for opportunistic infections deserve special interest. To study the risk factors, the long-term CD4 counts evolution, and the risk of death of patients who persistently maintain low CD4 counts, despite virological response to HAART, within a multicenter, hospital-based cohort study. A total of 147 patients were selected from CoRIS-MD and classified into a "Low-Group" or a "High-Group", depending on their CD4 counts after two-years of effective HAART (threshold 250 cells/microL). Associated risk factors were analysed by logistic regression, the CD4 dynamics were evaluated over a total period of 7.70 years (IQR, 6.70-9.00), and mortality was estimated by Cox proportional hazard. A total of 40 patients (27%) were classified into the "Low-Group". The odds ratio for this group increased with age, being 4.56 (2.23-9.33) for over 40, and was also higher among IDU, 3.63 (1.04-12.68). Six years thereafter, among these patients, only a 30% exceeded 350 CD4 cells/microL and a 12% exceeded 500 CD4 cells/microL. Furthermore, the "Low-Group" had a death rate of 2.42 per 100 persons/year (95%CI, 1.01-5.81), although once adjusted by age the estimates were no longer significant [4.14 (0.87-19.72)]. Our results suggest that those HIV patients who have not overcome the critical threshold of 250 CD4 cells/microL after a two years period of virologically effective HAART do persist with the aforementioned failure of CD4 restoration for a much longer time.
    Current HIV research 11/2009; 7(6):612-9. · 1.98 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: To estimate incidence rates and risk factors for tuberculosis (TB) in human immunodeficiency virus seroprevalent subjects. Multicentre, hospital-based cohort study of patients presenting to 10 Spanish hospitals from 1 January 1997 to 31 December 2003. Poisson regression was used and highly active antiretroviral treatment (HAART) was modelled as a time-dependent covariate. A total of 4268 patients were followed for a median of 3.8 years; 221 TB cases were diagnosed over 16 464 person-years (py). TB rates were higher in HAART-naïve subjects (1.56 per 100 py, 95%CI 1.36-1.79) than those on HAART (0.5/100 py, 95%CI 0.31-0.80). Among HAART-naïves, TB risk factors were: being male, being an injecting drug user (IDU) (RR 2.01, 95%CI 1.28-3.16), having low CD4 counts (P < 0.001) and high viral loads (P < 0.001). HAART was protective (RR 0.26, 95%CI 0.16-0.40) and reductions in TB rates were observed in the last calendar period (RR 0.74, 95%CI 0.55-1.00). For patients on HAART, no differences were observed by category of transmission. Low CD4 counts at entry were associated with higher TB rates (P < 0.001). HAART was associated with lower TB rates, and TB risk factors differed according to whether or not patients had received HAART. To further reduce TB rates, additional strategies are needed, such as timely access and adherence to HAART, especially in IDUs.
    The International Journal of Tuberculosis and Lung Disease 12/2008; 12(12):1393-400. · 2.76 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: A major cause of liver cirrhosis and hepatocarcinoma is chronic infection by hepatitis C virus. Ethanol consumption is the most significant environmental factor that exacerbates the progression of chronic hepatitis C to liver cirrhosis and hepatocarcinoma, perhaps due to increased cytokine secretion together with increased lipid peroxidation. In this study, we compare the intensity of lipid peroxidation (estimated as malondialdehyde (MDA) serum levels), the antioxidant status, (measured as glutathione peroxidase (GPX) and superoxide dismutase (SOD) activities in red blood cells), and levels of cytokines derived from Th1 cells (such as interferon gamma (IFNG)), Th2 cells (such as interleukin (IL)-4), Th3 cells (such as transforming growth factor beta (TGF-beta)), and IL-6, IL-8, and tumor necrosis factor (TNF)-alpha in patients affected by chronic hepatitis C virus infection, 26 drinkers of alcohol and 40 nondrinkers of alcohol. Patients showed significantly higher TNF-alpha (Z = 4.92, P < 0.001), IL-8 (Z = 4.95, P < 0.001), IFNG (Z = 2.81, P = 0.005), TGF-beta (t = 2.12, P = 0.037), MDA (Z = 5, P < 0.001), but lower IL-6 (Z = 3.61, P < 0.001) and GPX (F = 4.30, P < 0.05) than controls, whereas no differences were observed regarding IL-4 (Z = 0.35, P = 0.72), GPX and SOD activities. Alcoholics showed significantly higher TNF-alpha, but lower IL-4, MDA, and GPX, than nonalcoholics. TNF-alpha was significantly related to albumin and prothrombin activity, whereas TGF-beta was significantly related to MDA levels. Thus, cytokine secretion is altered in HCV infection. This alteration mainly consists of a stimulation of Th1 cytokines and an inhibition--or at least, no stimulation--of Th2 cytokines; these changes are especially marked among alcoholics with HCV infection, and are accompanied by raised TGF-beta.
    Alcohol and Alcoholism 01/2008; 43(2):137-42. · 1.96 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Enfuvirtide is a high-cost, parenterally administered drug commonly used in late phases of HIV infection, when its efficacy may be compromised. To optimize enfuvirtide use, consensus recommendations for this purpose have been formulated by 247 physicians attending patients with HIV infection in Spain. A literature review was performed in which grades of evidence and recommendations were defined according to the origin of the data (randomized clinical trials, non-randomized studies, expert opinion). Twenty-eight local consensus meetings were held between May and September 2005 to discuss the most important aspects related to the use of enfuvirtide, following a pre-established system used in all the meetings. The main conclusions were as follows: a) enfuvirtide use is often excessively delayed and is given to patients with little chance of treatment success; b) enfuvirtide is indicated in patients who require antiretroviral treatment and for whom an optimum treatment with three other fully effective drugs cannot be designed; c) the most important prognostic factor is the availability of at least one other completely active drug; d) there is no infallible method to avoid the development of local reactions, but measures are available to decrease their incidence and severity; and e) patient counseling and training for correct administration of the drug are essential to improve adherence, the repercussions of local reactions and, of course, the efficacy of the treatment.
    Enfermedades Infecciosas y Microbiología Clínica 03/2007; 25(2):131-42. · 1.48 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: To describe the methodology and baseline results of the Spanish cohort of naïve HIV-infected patients included in the Research Network on HIV/AIDS (CoRIS). CoRIS is a multicenter, hospital-based prospective cohort of HIV sero-prevalent, retroviral-naïve subjects, over 13 years old, and seen at 17 hospitals in 8 of the 17 Autonomous Regions in Spain from January 2004 to October 2005. The socio-demographic characteristics, as well as epidemiological, clinical, laboratory and treatment data were recorded, and biological samples were collected at baseline and during follow-up. A total of 1,591 subjects have been included in CoRIS; 24% are women, median age at cohort entry is 36 years, and 74% were diagnosed during 2004 or 2005. Twenty-seven percent came from countries other than Spain, mainly Latin-America (16%) and sub-Saharan Africa (5%). Thirty-two percent had completed secondary education and 16% university studies. The most frequent categories of transmission were men having sex with men (37%) and heterosexual sex (36%); only 21% were injection drug users. At cohort entry, median CD4 count was 317 cells/mm 3 and median viral load was 52,300 copies/mL; 18% were diagnosed with AIDS. Main AIDS-defining illnesses were Pneumocystis jiroveci pneumonia (6.1%), esophageal candidiasis (3.3%) and tuberculosis (extrapulmonary, 3.0% and pulmonary 2.7%). There were 35 deaths (2.2%). Thirty-three percent of patients gave a baseline sample to the BioBank. CoRIS offers relevant information about the current epidemiological profile of HIV infection in Spain, where sexual transmission has become predominant. The type and amount of information obtained from clinical and epidemiological data collection together with biological samples demonstrate the viability of the project, which offers many possibilities for future research.
    Enfermedades Infecciosas y Microbiología Clínica 02/2007; 25(1):23-31. · 1.48 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Enfuvirtide is a high-cost, parenterally administered drug commonly used in late phases of HIV infection, when its efficacy may be compromised. To optimize enfuvirtide use, consensus recommendations for this purpose have been formulated by 247 physicians attending patients with HIV infection in Spain. A literature review was performed in which grades of evidence and recommendations were defined according to the origin of the data (randomized clinical trials, non-randomized studies, expert opinion). Twenty-eight local consensus meetings were held between May and September 2005 to discuss the most important aspects related to the use of enfuvirtide, following a pre-established system used in all the meetings. The main conclusions were as follows: a) enfuvirtide use is often excessively delayed and is given to patients with little chance of treatment success; b) enfuvirtide is indicated in patients who require antiretroviral treatment and for whom an optimum treatment with three other fully effective drugs cannot be designed; c) the most important prognostic factor is the availability of at least one other completely active drug; d) there is no infallible method to avoid the development of local reactions, but measures are available to decrease their incidence and severity; and e) patient counseling and training for correct administration of the drug are essential to improve adherence, the repercussions of local reactions and, of course, the efficacy of the treatment.
    Enfermedades Infecciosas y Microbiología Clínica 02/2007; 25(2):131–142. · 1.48 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Objective To describe the methodology and baseline results of the Spanish cohort of naïve HIV-infected patients included in the Research Network on HIV/AIDS (CoRIS). Methods CoRIS is a multicenter, hospital-based prospective cohort of HIV sero-prevalent, retroviral-naïve subjects, over 13 years old, and seen at 17 hospitals in 8 of the 17 Autonomous Regions in Spain from January 2004 to October 2005. The socio-demographic characteristics, as well as epidemiological, clinical, laboratory and treatment data were recorded, and biological samples were collected at baseline and during follow-up. Results A total of 1,591 subjects have been included in CoRIS; 24% are women, median age at cohort entry is 36 years, and 74% were diagnosed during 2004 or 2005. Twenty-seven percent came from countries other than Spain, mainly Latin-America (16%) and sub-Saharan Africa (5%). Thirty-two percent had completed secondary education and 16% university studies. The most frequent categories of transmission were men having sex with men (37%) and heterosexual sex (36%); only 21% were injection drug users. At cohort entry, median CD4 count was 317 cells/mm3 and median viral load was 52,300 copies/mL; 18% were diagnosed with AIDS. Main AIDS-defining illnesses were Pneumocystis jiroveci pneumonia (6.1%), esophageal candidiasis (3.3%) and tuberculosis (extrapulmonary, 3.0% and pulmonary 2.7%). There were 35 deaths (2.2%). Thirty-three percent of patients gave a baseline sample to the BioBank. Conclusions CoRIS offers relevant information about the current epidemiological profile of HIV infection in Spain, where sexual transmission has become predominant. The type and amount of information obtained from clinical and epidemiological data collection together with biological samples demonstrate the viability of the project, which offers many possibilities for future research.
    Enfermedades Infecciosas y Microbiología Clínica 01/2007; 25(1):23–31. · 1.48 Impact Factor
  • Enfermedades Infecciosas y Microbiología Clínica 06/2006; 24(5):354-5. · 1.48 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Leptin is an anorexia inductor peptide produced by adipocytes and related to fat mass. Leptin is also produced by fat under proinflammatory cytokine action. Our objective is to study serum leptin levels in relation to nutritional status and acute phase response in advanced-stage non-small cell lung cancer.Seventy-six patients newly diagnosed of non surgical non-small cell lung cancer before chemotherapy treatment and 30 healthy controls were included. BMI, serum leptin and cholesterol levels and lymphocyte count were decreased in lung cancer patients. Cytokine IL-6, TNF-alpha, sTNF-RII, sIL-2R, IL-12, IL-10 and IFN-gamma, and other acute phase reactants as alpha1 antitrypsin, ferritin, CRP and platelets were all raised in patients, whereas the IL-2 was decreased. We found a direct relationship between leptin and other indicators of the status of nutrition, especially total fat mass. We also found a close relationship between the status of nutrition and the performance status (Karnofsky index). However, serum leptin and nutritional status were inversely correlated with acute phase proteins and proinflammatory cytokines, suggesting a stress-type malnutrition. Although serum leptin levels, nutritional status and Karnofsky index are related to survival, at multivariate analysis they all were displaced by the acute phase reaction markers. These results suggest that cancer anorexia and cachexia are not due to a dysregulation of leptin production. Circulating leptin concentrations are not elevated in weight-losing cancer patients and are inversely related to the intensity of the inflammatory response. In advanced lung cancer patients serum leptin concentrations only depend on the total amount of fat.
    Cytokine 08/2002; 19(1):21-6. · 2.52 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: We studied 174 patients with SIRS criteria, 45 with sepsis, eight with severe sepsis and 13 with septic shock. Serum TNF-alpha, IL-6, IL-8 and IL-10 levels were raised in SIRS patients, even in those cases in which an infection could not be documented, and more intensely in severe sepsis and in patients who died (11%). The slope of the regression line between IL-10 and TNF-alpha was sharper in patients with severe sepsis and in those who died; an imbalance between pro- and anti-inflammatory cytokines may be related to poor prognosis. Increased IL-6 and IL-10, decreased muscle mass, raised BUN and low body temperature were all independently related to prognosis.
    Cytokine 09/2001; 15(4):232-6. · 2.52 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: To evaluate the safety and effectiveness of once-daily didanosine and nevirapine plus twice-daily stavudine versus twice-daily administration of all three drugs. This open-label, randomized, multicentre study enrolled 94 antiretroviral-naive patients with chronic HIV infection, CD4+ cell counts > 500 x 10(6) cells/l, and viral loads > 5000 copies/ml. Patients were treated with either 40 mg stavudine (twice daily) plus 400 mg didanosine (once daily) and 400 mg nevirapine (once daily) or 40 mg stavudine (twice daily) plus 200 mg didanosine (twice daily) and 200 mg nevirapine (twice daily). After 12 months, 68% of patients who received twice-daily didanosine and nevirapine had viral loads < 200 copies/ml in the intention-to-treat and 79% in the on-treatment analysis, respectively. The corresponding values for patients treated with didanosine and nevirapine, taken once-daily, were 73 and 85%. The percentages of patients in each group with viral loads < 5 copies/ml at 12 months were 40% (once daily ) and 45% (twice daily) for the intention-to-treat analysis. Five of 11 patients (45%) with plasma viral loads < 5 copies/ml at 12 months had detectable virus in tonsillar tissue. Genotypic resistance to nevirapine was noted in seven of the 14 patients with detectable viral load at month 12. Mean changes in CD4+ cell counts for patients treated with stavudine plus once- or twice-daily didanosine and nevirapine were 154 and 132 x 10(6) cells/l, respectively. Treatment was interrupted due to adverse events in seven patients (8%) (four who received once-daily didanosine and nevirapine and three treated with twice-daily doses). The combination of twice-daily stavudine plus once-daily didanosine and nevirapine was as safe and well tolerated as twice-daily administration of all three agents. Both regimens were equally effective in reducing viral loads and in increasing CD4+ cell counts.
    AIDS 12/2000; 14(16):2485-94. · 6.41 Impact Factor