PROJECT TITLE: METABOLIC SYNDROME AND NON-ALCOHOLIC FATTY LIVER AS CARDIOVASCULAR RISK FACTOR IN PATIENTS WITH HIV INFECTION. IMPORTANCE OF AGING
PRINCIPAL INVESTIGATOR: ROSA POLO RODRIGUEZ
TYPE OF RESEARCH PROJECT: MULTICENTER
NAME OF THE COORDINATOR: ROSA POLO RODRIGUEZ
DURATION OF THE PROJECT IN MONTHS (MAX. 24 MONTHS): 18
ABSTRACT (Objectives and Methodology of the project):
After the introduction of antiretroviral therapy life expectancy of HIV-infected patients has increased considerably. Despite the undoubted success, the prevalence of diabetes mellitus/insulin resistance, obesity, hypertension, and dyslipidemia, increased worldwide. The sum of the above risk factors constitutes the metabolic syndrome. One of the most important aspects of the presence of MS is the ability to identify patients with increased cardiovascular risk and its role as a cardiovascular risk factor. Aging is also a conventional cardiovascular risk factor and a risk factor for MS. Non-alcoholic fatty liver disease (NAFLD), the hepatic manifestation of MS, also show an increase in mortality from atherosclerotic heart disease. In fact, coronary heart disease is the second most common cause of death in people with NAFLD.
MS is prevalent disease that will increase in the coming years. This disease is associated with a higher cardiovascular risk. NAFLD, the hepatic manifestation of the MS, also increases the cardiovascular risk of these patients. In addition, the aging of our patients can help to increase the already high cardiovascular risk of HIV-infected patients. At present, the prevalence of these complications is unknown in our country, so improving the knowledge of this problem is essential in order to set the precise preventive and therapeutic activities. Furthermore, it should still clarify the role of some of the antiretroviral drugs in NAFLD. Indeed, the study of MS and NAFLD, and its role as a cardiovascular risk factor will contribute to increased awareness of the disease, thereby avoiding that the diagnosis could be made at an advanced stage of the disease.
The main objective of this project is to know the prevalence of MS and NAFLD in HIV-infected patients, and its implication as a cardiovascular risk factor in </> 50 years.
CALL FOR RESEARCH PROJECTS ON HEALTH – PROJECT PROPOSAL FORM
SECTION 1: BACKGROUND & STATE OF THE ART
After the introduction of antiretroviral therapy (ART), life expectancy of HIV-infected patients has increased considerably (1). Despite the undoubted success of ART, the prevalence of diabetes mellitus/insulin resistance, obesity, hypertension, and dyslipidemia, increased worldwide (2, 3). The sum of the above risk factors constitutes the metabolic syndrome (MS). One of the most important aspects of the presence of MS is the ability to identify patients with increased cardiovascular risk and its role as a cardiovascular risk factor. Aging is also a conventional cardiovascular risk factor and a risk factor for MS.
According to the “Third National Survey of Health and Nutrition Examination”, the prevalence of MS in the general US population has been estimated in 25{183831142c9017ef8d11bc394201b3ce8f49f92c175495ccacdd276a526f4ba7}, and it has increased in recent years (4). The steady increase in the prevalence of MS seems to be related to fast food intake, physical inactivity and obesity (5).
In HIV-infected patients, the prevalence of MS varies from 17{183831142c9017ef8d11bc394201b3ce8f49f92c175495ccacdd276a526f4ba7} to 45{183831142c9017ef8d11bc394201b3ce8f49f92c175495ccacdd276a526f4ba7} (6-18). There are several reasons that justify this increase in the prevalence of MS. On the one hand, some of the antiretroviral therapies (ART) employed have been associated with an increased risk of MS (6, 7, 10, 17-19). On the other hand, the high prevalence of diabetes and obesity in HIV-infected patients (20, 21), similar to what occurs in the general population. All these factors could be responsible of the greatest increase in the prevalence of these diseases in this group.
One of the problems associated with MS is the non-alcoholic fatty liver disease (NAFLD) (22, 23). NAFLD is defined as liver chronic inflammatory disease occurring in the absence of alcohol abuse and infection by hepatitis B virus (HBV) or C (HCV). NAFLD includes a wide spectrum of liver diseases ranging from the simple accumulation of fat or fatty liver through hepatic steatosis with inflammation (steatohepatitis), that can progress to fibrosis, cirrhosis and even hepatocellular carcinoma (24-27).
Patients with NAFLD, show an increase in mortality from atherosclerotic heart disease (28, 29). In fact, coronary heart disease is the second most common cause of death in people with NAFLD. It has been observed, when comparing these patients with controls, a higher prevalence of coronary calcified and non-calcified plaques, a higher prevalence of non-obstructive coronary stenosis, greater insulin resistance and higher levels of triglycerides (30). NAFLD therefore appears to be a strong predictor of coronary atherosclerosis regardless of the presence of other indicators of MS, which can be useful in coronary risk stratification (31).
NAFLD is today one of the most prevalent chronic liver disease in industrialized countries (27). Again, this is due to the current pandemic of obesity (32) as a result of current lifestyle (physical inactivity, inadequate food, …). It is estimated that its prevalence in the general population ranges from 25{183831142c9017ef8d11bc394201b3ce8f49f92c175495ccacdd276a526f4ba7}-46{183831142c9017ef8d11bc394201b3ce8f49f92c175495ccacdd276a526f4ba7}, increasing to 70{183831142c9017ef8d11bc394201b3ce8f49f92c175495ccacdd276a526f4ba7} in diabetics and 90{183831142c9017ef8d11bc394201b3ce8f49f92c175495ccacdd276a526f4ba7} among obese patients (33, 34). Its prevalence is increasing worldwide (35). So far, the data about the prevalence, predictors and natural history of NAFLD among HIV-infected patients is very limited. In the study Crum-Cianflone et al (36), NAFLD prevalence was 31{183831142c9017ef8d11bc394201b3ce8f49f92c175495ccacdd276a526f4ba7} based on ultrasound criteria and 36{183831142c9017ef8d11bc394201b3ce8f49f92c175495ccacdd276a526f4ba7} with liver biopsy. Guaraldi et al (37) observed a prevalence of 37{183831142c9017ef8d11bc394201b3ce8f49f92c175495ccacdd276a526f4ba7} based on CT criteria.
In previous studies, not having into account the HCV coinfection, the risk factors for its development include the use of some nucleoside analogs (especially stavudine and didanosine), age, white race, and the presence of MS (37-41). In contrast, other studies have not found an increased risk of NAFLD using the novel nucleoside analogues (36).
The diagnosis of NAFLD is often casual, in the context of performing an abdominal ultrasound for any reason, or because this technique has been ordered after the presence of alterations in the liver function tests. Biopsy, the gold standard, is becoming less used except in cases where it is necessary to conduct a more detailed study. This is because the availability of non-invasive tests such as FibroScan® with CAP (software) (42), or the use of other non-invasive analytical markers (43).
Because it is necessary to improve the knowledge about MS and NAFLD as a cardiovascular risk factor that can be aggravated by age, this cohort could be important for improving the knowledge of this problem and so establish programs for their prevention and control.
CALL FOR RESEARCH PROJECTS ON HEALTH – PROJECT PROPOSAL FORM
SECTION 2: REFERENCES
1. Lohse N, et al. Survival of persons with and without HIV infection in Denmark, 1995-2005. Annals of internal medicine. 2007.
2. Barbaro G. Metabolic and cardiovascular complications of highly active antiretroviral therapy for HIV infection. Current HIV research. 2006
3. Expert Panel on Detection E, Treatment of High Blood Cholesterol in A. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001
4. Mozumdar A, Liguori G. Persistent increase of prevalence of metabolic syndrome among U.S. adults: NHANES III to NHANES 1999-2006. Diabetes care. 2011
5. Wannamethee SG. The metabolic syndrome and cardiovascular risk in the British Regional Heart Study. International journal of obesity. 2008
6. Jerico C, et al. Metabolic syndrome among HIV-infected patients: prevalence, characteristics, and related factors. Diabetes care. 2005
7. Samaras K, et al. Prevalence of metabolic syndrome in HIV-infected patients receiving highly active antiretroviral therapy using International Diabetes Foundation and Adult Treatment Panel III criteria: associations with insulin resistance, disturbed body fat compartmentalization, elevated C-reactive protein, and hypoadiponectinemia. Diabetes care. 2007
8. Mondy K, et al. Metabolic syndrome in HIV-infected patients from an urban, midwestern US outpatient population. CID 2007
9. Sobieszczyk ME, et al. Prevalence and predictors of metabolic syndrome among HIV-infected and HIV-uninfected women in the Women’s Interagency HIV Study. JAIDS 2008
10. Hansen BR, et al. The prevalence of metabolic syndrome in Danish patients with HIV infection: the effect of antiretroviral therapy. HIV Medicine. 2009
11. Squillace N, et al. Detectable HIV viral load is associated with metabolic syndrome. JAIDS 2009
12. Worm SW, et al. High prevalence of the metabolic syndrome in HIV-infected patients: impact of different definitions of the metabolic syndrome. Aids. 2010
13. Gazzaruso C, et al. Prevalence of metabolic syndrome among HIV patients. Diabetes care. 2002
14. Bonfanti P, et al. Metabolic syndrome: a real threat for HIV-positive patients?: Results from the SIMONE study. JAIDs 2006
15. Jacobson DL, et al. Incidence of metabolic syndrome in a cohort of HIV-infected adults and prevalence relative to the US population (National Health and Nutrition Examination Survey). JAIDs 2006
16. Wu PY, et al. Metabolic syndrome among HIV-infected Taiwanese patients in the era of highly active antiretroviral therapy: prevalence and associated factors. JAC 2012
17. Krishnan S, et al. Metabolic syndrome before and after initiation of antiretroviral therapy in treatment-naive HIV-infected individuals. JAIDs 2012
18. Biron A, et al. Metabolic syndrome in French HIV-infected patients: prevalence and predictive factors after 3 years of antiretroviral therapy. AIDS Res Human Retrov 2012
19. Sebastiani G, et al. The impact of liver disease aetiology and the stages of hepatic fibrosis on the performance of non-invasive fibrosis biomarkers: an international study of 2411 cases. Aliment Pharmacol Ther. 2011
20. Brown TT, et al. Antiretroviral therapy and the prevalence and incidence of diabetes mellitus in the multicenter AIDS cohort study. Archives of internal medicine. 2005
21. Amorosa V, et al. A tale of 2 epidemics: the intersection between obesity, HIV infection Philadelphia. JAIDS 2005
22. Pagano G, et al. Nonalcoholic steatohepatitis, insulin resistance, metabolic syndrome: further evidence for an etiologic association. Hepatology. 2002
23. Marchesini G, et al. Nonalcoholic fatty liver disease and the metabolic syndrome. Minerva Cardioang 2006
24. Matteoni CA, et al. Nonalcoholic fatty liver disease: a spectrum of clinical and pathological severity. Gastroenterology. 1999
25. Fassio E, et al. Natural history of nonalcoholic steatohepatitis: a longitudinal study of repeat liver biopsies. Hepatology. 2004
26. McCullough AJ. Pathophysiology of nonalcoholic steatohepatitis. Journal of clinical gastroenterology. 2006
27. Bellentani S, Marino M. Epidemiology and natural history of non-alcoholic fatty liver disease (NAFLD). Annals of hepatology. 2009
28. Bjornsson E. The clinical aspects of non-alcoholic fatty liver disease. Minerva Gastroenterol Dietol. 2008
29. Sookoian S et al. Non-alcoholic fatty liver disease is strongly associated with carotid atherosclerosis: a systematic review. J Hepatology. 2008
30. Lizardi-Cervera J, Aguilar-Zapata D. Nonalcoholic fatty liver disease and its association with cardiovascular disease. Annals Hepatol 2009
31. Assy N, et al. Presence of coronary plaques in patients with nonalcoholic fatty liver disease. Radiology. 2010
32. Swinburn BA, et al. The global obesity pandemic: shaped by global drivers and local environments. Lancet. 2011
33. Ratziu V,et al. A position statement on NAFLD/NASH based on the EASL 2009 special conference. J Hepatol 2010
34. Williams CD, et al. Prevalence of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis among a largely middle-aged population utilizing ultrasound and liver biopsy: a prospective study. Gastroenterology. 2011
35. Zimmet P, et al. The metabolic syndrome: a global public health problem and a new definition. J atherosclerosis and thrombosis. 2005
36. Crum-Cianflone N, et al. Nonalcoholic fatty liver disease among HIV-infected persons. JAIDs 2009
37. Guaraldi G, et al. Nonalcoholic fatty liver disease in HIV-infected patients referred to a metabolic clinic: prevalence, characteristics, predictors. CID 2008
38. McGovern BH, et al. Hepatic steatosis is associated with fibrosis, nucleoside analogue use, and hepatitis C virus genotype 3 infection in HIV-seropositive patients. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2006
39. Bani-Sadr F, et al. Hepatic steatosis in HIV-HCV coinfected patients: analysis of risk factors. Aids. 2006
40. Akhtar MA, et al. Hepatic histopathology and clinical characteristics associated with antiretroviral therapy in HIV patients without viral hepatitis. European journal of gastroenterology & hepatology. 2008
41. Zeremski M, Talal AH. Dideoxynucleoside analogues should be used cautiously in patients with hepatic steatosis. CID 2006
42. Chalasani N, Yet al. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012
43. Angulo P, et al. The NAFLD fibrosis score: a noninvasive system that identifies liver fibrosis in patients with NAFLD. Hepatology. 2007
44. Hashimoto E, et al. Characteristics and diagnosis of NAFLD/NASH. J Gastroenterology and hepatology. 2013
45. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: executive summary. Expert Panel on the Identification, Evaluation, and Treatment of Overweight in Adults. Am J Clinical nutrition. 1998
46. Domingo P, et al. Relationship between HIV/Highly active antiretroviral therapy (HAART)-associated lipodystrophy syndrome and stavudine-triphosphate intracellular levels in patients with stavudine-based antiretroviral regimens. CID 2010
47. Lichtenstein KA, et al. Clinical assessment of HIV-associated lipodystrophy in an ambulatory population. Aids. 2001
48. Vallet-Pichard A, et al. FIB-4: an inexpensive and accurate marker of fibrosis in HCV infection. comparison liver biopsy and fibrotest. Hepatology. 2007
49. Williams AL, et al. Ratio of serum aspartate to alanine aminotransferase in chronic hepatitis. Relationship to cirrhosis. Gastroenterology. 1988
50. Wai CT, et al. A simple noninvasive index can predict both significant fibrosis and cirrhosis in patients with chronic hepatitis C. Hepatology. 2003
CALL FOR RESEARCH PROJECTS ON HEALTH – PROJECT PROPOSAL FORM
SECTION 3: HYPOTHESIS AND OBJECTIVES
HYPOTHESIS:
MS is a prevalent disease that will increase in the coming years. This disease is associated with a higher cardiovascular risk. NAFLD, the hepatic manifestation of the MS, also increases the cardiovascular risk of these patients. In addition, the aging of our patients can help to increase the already high cardiovascular risk of HIV-infected patients
At present, the prevalence of these complications is unknown in our country, so improving the knowledge of this problem is essential in order to set the precise preventive and therapeutic activities. Furthermore, it should still clarify the role of some of the antiretroviral drugs in NAFLD.
Indeed, the study of MS and NAFLD, and its role as a cardiovascular risk factor will contribute to increase awareness of the disease. Thereby, we avoid that the diagnosis can be made at an advanced stage of the disease.
OBJETIVES:
Primary
-To know the prevalence of MS and NAFLD in HIV-infected patients and its implication as a cardiovascular risk factor in patients </>50 years.
Secondary
-To describe the demographic and anthropometric characteristics of the patients with MS and NAFLD and its implication as a cardiovascular risk factor in patients </>50 years.
-To describe the relationship between the presence of lipoatrophy and/or lipohypertrophy with MS and NAFLD and its implication as a cardiovascular risk factor in patients </>50 years.
-To describe the characteristics of personal history (comorbidities) in patients with MS and NAFLD and its implication as a cardiovascular risk factor in patients </>50 years.
-To describe the immunological, virological, therapeutic and prognostic features associated with HIV infection in patients with MS and NAFLD and its implication as a cardiovascular risk factor in patients </>50 years.
-To describe the characteristics of patients with MS and NAFLD based on the Child-Pugh, FibroScan®, FibroScan® classification parameter controlled dimming and noninvasive parameters for measuring the degree of fibrosis, and its implication as a cardiovascular risk factor in patients </>50 years.
-To analyze the relationship between the various parameters, indices and variables described above in the diagnostic criteria of MS and NAFLD and its implication as a cardiovascular risk factor in patients </>50 years.
CALL FOR RESEARCH PROJECTS ON HEALTH – PROJECT PROPOSAL FORM
SECTION 4: METHODOLOGY
Study: Cross-sectional and prospective study.
Study subjects: HIV-infected patients attended in consultation.
Study period: Patients seen on a scheduled basis in any of the GEAM centers during the months of January 2016 to June 2017.
GEAM centers are:
• Andalucía: H. Virgen de la Victoria de Málaga*; Hospital Universitario Nuestra Señora de Valme (Sevilla); HU Virgen de las Nieves de Granada
• Aragón: Hospital Miguel Servet
• Asturias: HU Central de Asturias
• Cataluña: H. de Figueras; H. Germans Trias i Pujol; H. General de Granollers.
• Galicia: Complejo Hospitalario Universitario de Ferrol; HU de Vigo; HU A Coruña
• La Rioja: Hospital San Pedro
• Burgos: Hospital Universitario de Burgos
• Madrid: HU La Princesa, H. de Alcalá, H. Carlos III*; H. Severo Ochoa; H. Infanta Leonor.
• País Vasco: Hospital de Donosti.
• Valencia: HGU Valencia; H. La Fe; H. Clínico de Valencia*; H. Arnau de Vilanova*.
*GEAM centers that were interested in participating in the project but whose leaders have been unable to submit their CV for being on holidays.
Criteria:
Inclusion criteria:
– Confirmed HIV-1 infection.
– Compliance to participate in the study.
– Stable antiretroviral therapy for at least 48 weeks, regardless of their HIV viral load.
– Diagnosis of MS.
The SM will be defined based on the recommendations of the ATP III (3) by the presence of ≥3 of the following abnormalities:
• Abdominal obesity (waist circumference >102 cm in men and >88 cm for women).
• High triglycerides (>150 mg/dL) or specific medication for controlling it.
• Decreased level of HDL-cholesterol (<40 mg/dL in men and <50 mg/dL in women).
• High blood pressure (SBP >135 mmHg and/or DBP >85 mmHg) or specific medication for controlling it, and
• High levels of fasting glucose (>110 mg/dL) or specific medication for controlling it.
– Diagnosis of NAFLD: will be based on the presence of the following three criteria: non-alcoholic, detection of steatosis either by imaging (abdominal ultrasound, computed tomography or magnetic resonance) or by histology, and appropriate exclusion of other liver diseases (44). In the case of the abdominal ultrasound, NAFLD will be defined based on the presence of at least two of the following findings: increased hepatorenal contrast, liver brightness, deep attenuation, and vascular blurring (44).
– Patients may have received in the 6 months prior to recruitment period lipid lowering or antidiabetic.
Exclusion criteria:
– Patients <18 years.
– Pregnant.
– Serology HBsAg +.
– Serology HCV+.
– Autoimmune hepatitis.
– Excessive alcohol consumption (ethanol > 50 g/day).
– Current consumption of illegal drugs.
– Treatment with drugs that can cause hepatic steatosis (e.g. salicylates, NSAIDs, corticosteroids, estrogens, amiodarone, valproate, methotrexate and diltiazem.).
– Other diseases: primary biliary cirrhosis, sclerosing cholangitis, hemochromatosis or Wilson’s disease.
Follow-up: Visits at 24 weeks, 48 weeks and 96 weeks.
Study variables:
– Demographic: age (years), sex (male / female), race / ethnicity (Caucasian, Hispanic, African, Asian, Gypsy).
– Anthropometric: Weight (kg) Height (cm), body mass index (BMI) (45), circumference (cm) waist and hip. Abdominal obesity (yes / no).
– Lipoatrophy will be identified by patient self-reporting and/or clinician observation of relevant changes to the face (loss of cheek and/or preauricular fat pads), arms, legs, and subcutaneous abdominal tissue, and it will be confirmed clinically by qualitative physical examination (46). Lipohypertrophy will be diagnosed by the presence of central adiposity (defined by a waist: hip ratio of >0.90 in men and >0.80 in women), breast enlargement in women, or the appearance of cervical fat pads or supraclavicular fat accumulation (46). Lipoatrophy and lipohypertrophy occurred both in an isolated manner and concomitantly, and any combination of them will be considered to be a mixed syndrome. Visual aspects of lipodystrophy will be assessed with a lipodystrophy severity grading scale (LSGS) based on that reported by Lichtenstein et al (47).
– Personal history: Diabetes mellitus (diagnosis or previous treatment, or two fasting blood glucose> 125 mg / dl) (yes / no), hypertension (prior diagnosis or treatment or lowering systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg ) (yes / no), dyslipidemia (a diagnosis or previous lipid-lowering therapy, LDL cholesterol (LDL-C)> 160 mg / dl, cholesterol, high density lipoprotein (HDL) cholesterol <35 mg / dL for men and <45 mg / dl for women) (yes / no), menopause (yes / no), active smoking (consumption of one or more cigarettes / day on average or former smoker <1 year) (yes / no). Physical activity> 4 hours / week (yes / no) (37).
– Related to HIV infection: Years since diagnosis, transmission route (man who has sex with men, heterosexual drug users injecting, others), CD4 nadir (<200, 200-499, > lymphocytes 500), CDC stage (A, B, C).
– Current ART: cumulative exposure (in months) of nucleoside analogues, non-nucleoside analogues, protease inhibitors, integrase inhibitors, fusion antagonists, and CCR5 antagonists.
– Previous ART: cumulative exposure (in months) of nucleoside analogues, non-nucleoside analogues, protease inhibitors, integrase inhibitors, fusion antagonists, and antagonists of CCR5.
– Use of non-HIV-related therapies: oral agents and / or insulin (yes / no), antihypertensives (yes / no), lipid lowering drugs (statins, fibrates) (yes / no).
– Analytical determinations: complete blood count, prothrombin time, ALT, AST, GGT, alkaline phosphatase, total bilirubin, albumin, creatinine, estimated glomerular filtration rate, fasting glucose, insulin if available, HOMA index, total cholesterol, HDL-C, LDL-C, triglycerides, vitamin D & E, PTH, AFP, and C-reactive protein (CRP). In addition, the most recent CD4, CD8 and HIV viral load.
– 10-year cardiovascular risk (Framingham).
– FibroScan® (as close as possible to the realization of ultrasound) (kPa).
– FibroScan® with CAP (as close as possible to the realization of ultrasound –if available-).
– Evaluation of other noninvasive parameters: FIB-4 index (48), AST/ALT ratio (49), APRI index (50), NAFLD index (43).
Statistic analysis
Quantitative variables are described as mean ± standard deviation. The median and interquartile range was used for the quantitative description of discrete variables. For its part, the qualitative variables will be described using absolute and relative frequencies (percentages). The Student t test or ANOVA was used to compare continuous variables. Categorical variables were compared using the chi-square. A logistic regression was performed to explain the variable MS and NAFLD according to the variables described above will be considered significant at P <0.05.
Ethical aspects
This study will be carried out following the ethical rules in the international regulations for ethical review of epidemiological studies and biomedical research involving human subjects (Declaration of Helsinki of 1964, last amended in 2008).
Participants will be informed of the intended purposes and the voluntary nature of their participation, respecting their right to privacy. Prior to conducting the interview request in writing consent of the subjects studied. Researchers agree to maintain the confidentiality of personal data and to notify all participating patients all data that may be relevant to your health now. This project has been sent to the Research Committee of the San Pedro Hospital in La Rioja.
Limitations:
Among the study’s limitations is that we do not know the prevalence of MS and NAFLD in this group. However, this is precisely what gives strength and knowledge about prevalence is really necessary to carry out any work.
CALL FOR RESEARCH PROJECTS ON HEALTH – PROJECT PROPOSAL FORM
SECTION 5: WORK PLAN
All the HIV-infected patients of our Centers will be evaluated for their inclusion in the study. Only those that meet the selection criteria will be selected.
R Polo, project leader, will be the responsible of the coordination of project.
All the co-investigator will identify patients, will propose their participation in the study, and will get the informed consent.
During the first 6 months we will recruitment the patients. After that, we will follow-up. During the first 6 months a databases will be generated for the study, data analysis, and presentation in national and international forums and publications.
CALL FOR RESEARCH PROJECTS ON HEALTH – PROJECT PROPOSAL FORM
SECTION 6: EXPERIENCE
The Study Group on Metabolic Disorders and Comorbidities (GEAM) was created more than 15 years ago like a forum for discussion and debate that wanted to respond to daily clinical problems. Experts of different biomedical medical science people always have addressed these topics. The group consists of multiple specialists (over 150) from different areas who are directly, or indirectly, related to metabolic disorders and HIV infection. Their main objective is working together to find the best treatment regimens and the best approach to HIV patients with metabolic disorders. This group has produced several publications of great clinical impact. GEAM Group performs, along with the National AIDS Plan the following review “Recommendations on metabolic and morphological changes in HIV infection”.
So, all the researchers have great experience in this field. This group clearly represents a very good example of an active research group, which would ensure the project’s success.
CALL FOR RESEARCH PROJECTS ON HEALTH – PROJECT PROPOSAL FORM
SECTION 7: AVAILABLE RESOURCES
Nothing is indicated.
CALL FOR RESEARCH PROJECTS ON HEALTH – PROJECT PROPOSAL FORM
SECTION 8: BUDGET JUSTIFICATION
1. Creating a database to facilitate the inclusion of survey data and subsequent analysis. Laptop.
2. Administrative expenses
3. Statistical analysis
4. Expenditure on publication of articles
5. Initial meeting to launch the project and an end to all the concluding analysis
6. Attendance at national and international congresses.
No other co-founding are available
CALL FOR RESEARCH PROJECTS ON HEALTH – PROJECT PROPOSAL FORM
ANNEXES
STRATEGIC FRAMEWORK FOR PROJECT
This project has clear benefits in the strategic framework for health care to chronic patients. The fundamental objectives therefore are intended to know the prevalence of this serious public health problem in the group of patients with HIV infection in our country, which in turn will allow us to identify areas for improvement.
Furthermore, this study will be carried out at national level, enable us to establish synergies work whose ultimate scientific goal will be transferred to clinical practice results.
The findings derived from this project will be made public to the scientific community through papers at international and national conferences as well as through original articles published in international journals of impact.