Made available in DSpace on 2014-06-11T19:31:29Z (GMT). No. of bitstreams: 0 Previous issue date: 2008-02-25Bitstream added on 2014-06-13T20:02:02Z : No. of bitstreams: 1 geraix_j_dr_botfm.pdf: 538830 bytes, checksum: a76b460005466efa7d2941012c34da2d (MD5) / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) / Universidade Estadual Paulista (UNESP) / O advento da utilização da terapia antiretroviral de alta atividade (HAART), a partir de 1996, representou um profundo impacto na história natural da infecção pelo HIV, promovendo uma importante e sustentada supressão na replicação viral, elevando a sobrevida e a qualidade de vida dos pacientes soropositivos. No entanto, gradualmente, foi se observando que a terapia antiretroviral é acompanhada de alterações metabólicas, como dislipidemia, principalmente hipertrigliceridemia, resistência insulínica, hiperglicemia e lipodistrofia, isto é, redistribuição da gordura corporal. Ensaios epidemiológicos demonstram correlação entre os níveis elevados de triglicerídeos (TG) e maior incidência de doença arterial coronariana (DAC). Autores sugerem a intervenção dietética como parte do tratamento da hiperlipidemia, incluindo aumento da ingestão de fibra solúvel (10g-25g/dia). Há estudos demonstrando que tanto o colesterol quanto os triglicerídeos séricos diminuem com a utilização de fibra alimentar. Alguns observaram redução apenas nos níveis séricos de triglicerídeos, enquanto que outros não verificaram alteração no metabolismo lipídico. O objetivo do presente estudo foi avaliar o efeito da fibra solúvel (goma guar parcialmente hidrolisada) suplementar sobre a hipertrigliceridemia e o perfil imunológico de indivíduos HIV positivo em tratamento com HAART. Foram estudados 19 pacientes HIV positivo com hipertrigliceridemia (níveis séricos ³ 150 a < 500mg/dL), sendo 63,16% do sexo masculino e 36,84% feminino, com média de idade de 43,52 ± 9,22 anos. Esses indivíduos utilizavam o mesmo esquema HAART há pelo menos seis meses, sem mudança da terapia durante o estudo e receberam 20g de fibra solúvel por dia, durante quatro meses... / The advent of highly active antiretroviral therapy (HAART), since 1996, represented a profound impact on the natural history of HIV-infection by promoting important and sustainable viral replication suppression and increasing survival and quality of life among seropositive patients. Nonetheless, antiretroviral therapy has been observed to be accompanied by metabolic alterations such as dyslipidemia, especially hypertriglyceridemia, insulin resistance, hyperglycemia and lipodystrophy (body fat redistribution). Epidemiological studies have demonstrated a correlation between high triglyceride (TG) levels and higher incidence of coronary artery disease (CAD). Some investigators suggest dietary intervention as part of hyperlipidemia treatment, including an increase in soluble fiber intake (10-25g/day). Whereas some studies have demonstrated that both cholesterol and serum triglyceride levels decrease with the use of food fiber, others have shown just a serum triglyceride decrease, and others failed to observe any alteration in lipid metabolism. The purpose of this study was to assess the effect of soluble fiber® (partially hydrolyzed guar gum) supplementation on hypertriglyceridemia and immune profile in HIV-positive individuals on HAART. Nineteen HIV-positive individuals with hypertriglyceridemia (serum levels 150 to < 500 mg/dL) were studied. Of these individuals, 63,16% were males and 36,84% females, with mean age of 43,52 ± 9,22 years. These individuals had been on the same HAART regimen for at least 6 months, had no change in therapy during the study and received 20g/day of soluble fiber for four months at pre-established times. Clinical-nutritional, biochemical (total proteins, albumin, globulin, total cholesterol, LDL-c, HDL-c, TG, TG/HDL-c and LDL-c/HDL-c)... (Complete abstract click electronic access below)

Magister Pharmaceuticae - MPharm / South Africa faces a huge Human Immunodeficiency Virus (HIV) burden with more than 400,000 children currently on antiretroviral therapy (ART). Studies on lipid and haematological profile changes in paediatrics are of particular interest since these children are exposed to ART in the course of a developmentally significant period and will possibly have longer collective exposure to ART. As such, monitoring for adverse effects, including lipid and haematological abnormalities, is essential for curtailing morbidity and mortality rates of children on ART. There is a dearth of studies assessing lipid and haematological abnormalities in the South African paediatric population on ART where genetic differences, co-morbidities, malnutrition and use of traditional medicines, all influence the safety profile of a drug. The goal of this study was twofold: Firstly to identify a suitable parameter for assessing lipid and haematological abnormalities in paediatrics on Antiretroviral (ARV) treatment using available secondary data and secondly, to assess prescriber adherence to routine monitoring tests in the ART guidelines. This study was a retrospective review of secondary data obtained from 168 patient clinical records at a Community Health Centre in the Cape Metropole, Western Cape and corresponding laboratory data from the National Health Laboratory Service (NHLS) database. Appropriate cholesterol, triglyceride, haemoglobin and neutrophil test results were compared against the standard reference ranges/values. The Chi-Squared test identified associations between total cholesterol (TC) /triglycerides and haemoglobin (Hb)/neutrophil and other independent variables. Evaluation of health care provider adherence to routine monitoring tests was assessed against relevant national ARV management guidelines. There was a paucity of baseline data for all laboratory markers and infrequent follow-up tests were ordered by healthcare providers. This precluded the measurement of changing lipid and haematological levels and an alternative parameter, viz., the highest available laboratory test value for each marker per patient, was assessed against reference values/ranges. Only nine out of the 36 (25%) patients on an AZT regimen had any Hb or neutrophil laboratory tests performed and 23 and two out of 97 (24% and 2%) patients, respectively, on a protease inhibitor (PI) had a TC and triglyceride laboratory test performed. Anaemia was detected in 45.5 % of children below five years of age, in 21.7% between ages of six and 11 and in 65.5 % between 12 and 14 years of age. Neutropenia was detected in 25.6% of children below five years of age and in 50% aged between six and 11. Hypercholesterolemia was found in 13.1% of patients. The only statistically statistical associations were found between the TC and CD4 count in children aged six to 14 years (χ2=5.000; p=0.025) and between neutrophil counts and viral load in children aged six to 14 years (χ2=6.4532; p=0.0240). A significant association was also found between Hb levels and viral load (χ2=7.000; p=0.008). In the absence of baseline test results and routine monitoring of haematological and lipid profiles, this study presents a potential alternative marker for assessing lipid and haematological abnormalities using the highest level of neutrophil, Hb, TC and triglycerides recorded for each patient.

The purpose of this study was to describe the experiences of elderly people caring for HIV positive orphans on antiretroviral treatment in Swaziland. An exploratory, descriptive and contextual qualitative study based on a phenomenological approach was conducted. Data was collected by means of semi structured interviews with twelve elderly people purposively selected at Mbabane Government Hospital antiretroviral treatment clinic. The findings of the study highlighted that the elderly people were giving care under compulsion with very little support from the government, the community or other organisations. Their care giving capacity was compromised by many challenges which included the heavy burden of caring for a number of dependents; economic constraints; poor infrastructure; food insecurity, and physical, psychological and social constraints. The elderly were employing a number of coping strategies to counteract the challenges that they were facing. The researcher concluded that the elderly people were vital in ensuring the survival of sick orphans under the paediatric antiretroviral treatment programme in Swaziland if afforded sufficient support and empowerment. / Health Studies / M.A. (Public Health)

A research report submitted to the Faculty of Medicine, University of the Witwatersrand, in partial fulfillment of the requirements for the Degree of Master of Medicine in the division of Plastic and Reconstructive Surgery. Johannesburg 2014 / With 67% of the world’s human immunodeficiency virus (HIV) infected population existing in Sub-Saharan Africa and recent access to highly active antiretroviral therapy (HAART); demand for plastic surgical intervention in addressing HIV-associated lipodystrophy has expanded dramatically. This study assessed the prevalence of lipodystrophy in a random clinic cohort, the demand for surgical correction, and risk of treatment non-compliance A questionnaire and database cross-sectional review of 554 patients was performed over a three-month period at the Themba Lethu Clinic, Johannesburg, South Africa. A total of 479 patients completed the questionnaire, 83% were female. Nearly 90% of patients were currently being treated, or had been treated with stavudine (d4T). The prevalence of lipodystrophy was 11.7%. Nearly 5.9% of patients had considered stopping treatment due to changes in body morphology following the onset of HAART, 47% of patients interviewed would consider surgery to correct unwanted physical changes following treatment with HAART. Male patients were satisfied by physical changes in their body habitus following treatment (pre-treatment satisfaction 38% vs. post-treatment satisfaction of 94%). Female patients had 6.5 times more breast hypertrophy related symptoms than in their pretreatment state. This study identified a prevalence of 11.7% of patients with HIV-associated lipodystrophy. A total of 3.8% of all patients would consider non-compliance on the basis of this side effect alone. The demand for surgical correction is significant, extends beyond patients diagnosed with HIV-associated lipodystrophy, and needs to be addressed.

M.Sc. (Epidemiology), Faculty of Health Sciences, University of the Witwatersrand, 2011 / Background and Objectives The advent of Highly Active Antiretroviral Therapy (HAART) has resulted in a significant reduction in HIV/AIDS related morbidity and mortality in sub-Saharan Africa. However, toxicities due to HAART continue to pose challenges to the success of different regimens. Severe hepatotoxicity is one of the significant adverse events occurring in patients on HAART. Information on the incidence and risk factors for severe hepatotoxicity in cohorts from resource poor settings is limited. It is against this background that we undertook the study to determine the incidence and explore factors associated with severe hepatotoxicity following HAART initiation in a South African cohort. Materials and Methods Secondary data analysis of a prospective cohort 9764 HIV-infected adult patients initiated on HAART at the Themba Lethu clinic antiretroviral rollout facility in Johannesburg, South Africa between 1st April 2004 and 30th June 2009 was conducted. Severe hepatotoxicity cases were identified within the first 12 months of initiating HAART as grade 3 or 4 elevation in baseline ALT levels. The incidence rate of severe hepatotoxicity was calculated and potential socio-demographic and clinical predictors were explored using Cox proportional hazard regression modelling. Results At baseline, 91.8% of patients were commenced on an efavirenz-based regimen while only 8.2% were on a nevirapine-based regimen. The median CD4 count at v initiation of HAART for this cohort was 80 cells/ mm3, a figure lower than the Department of Health (DoH) CD4 cut off for initiating HAART of 200 cells/ mm3. The overall incidence rate of severe hepatotoxicity was 10.7 (95% CI: 8.7 – 13.1) cases per 1000 p-yrs of follow-up. The period with the highest risk of severe hepatotoxicity was within 2 months of initiating HAART. Incidence of severe hepatotoxicity was 21.1(95% CI: 12.7 – 34.9) cases per 1000 p-yrs among patients on a nevirapine-based regimen and 9.7 (95% CI: 7.8 – 12.1) cases per 1000 p-yrs in those on an efavirenz-based one. The hazard for severe hepatotoxicity within the first year of initiating HAART was 2.17 times higher in individuals on a nevirapine-based regimen compared to those on an efavirenz-based regimen after adjusting for baseline ALT, baseline CD4, age and gender (HR = 2.17; 95%CI = 1.18 – 3.97; p = 0.013). Though imprecise, the estimate for baseline ALT category suggested an increased risk for severe hepatotoxicity in individuals with a baseline ALT more than 40 I.U/L compared to those with a baseline ALT of less than 40 I.U/L (HR = 1.63; 95%CI = 1.00 – 2.67; p = 0.050). Conclusion The results of the study suggest that severe hepatotoxicity following initiation of HAART in this cohort is low compared to other previously studied cohorts. The high incidence rate of severe hepatotoxicity in the first two months of initiating HAART necessitates the need for more frequent and careful monitoring of ALT levels early during therapy. Patients on a nevirapine-based regimen have a higher risk of developing severe hepatotoxicity when compared to their counterparts on an efavirenz-based regimen, a result consistent with findings from previous studies.

M. Pharm., Faculty of Health Sciences, University of the Witwatersrand, 2011 / Background: According to the 2010 edition of the UNAIDS Report on the global AIDS epidemic, an estimated 320 000 (20%) fewer people died of AIDS-related causes in South Africa in 2009 than in 2004 due to the increase in availability of anti-retroviral medicines.(2) With this positive trend, the mindset should be shifted towards reducing adverse effects of ART. The need for permanent ART treatment and the significant increase in life expectancy have led to the observation of new, frequent, and sometimes severe drug-related adverse effects.(4) One of the most challenging and potentially dangerous side-effects is hyperlactataemia (Hlac) that may evolve to lactic acidosis (LA)(5) ART–associated Hlac may be asymptomatic, or symptomatic which in the extreme case can progress to life threatening acidosis. The latter, i.e. lactic acidosis is a fairly frequent and often misdiagnosed or under diagnosed and potentially fatal side effect of ARTs. (6) Objectives: To explore the relationship between Hlac/LA and gender, weight, dosage CD4 and regimen alterations in HIV patients on ARTs and to compare the earlier regimens to the revised regimens as independent risk factors for Hlac and LA. Sample size would be based on the hypothesis that newer regimens would reduce the incidence of Hlac and LA. Methods: A Retrospective study was conducted by reviewing 3 741 patient files from August 2004 to December 2007. This study was to assess the incidence and risk factors of Hlac/LA. Hlac was defined as a venous lactate measurement of ≥2.3mmol/L and LA was ≥5mmol/L. Immunological, virological, haemotological and biochemical results were recorded for all the patients. A second phase involved a Prospective study. Patients who were on treatment for >12 months were randomly selected from the queue at the clinic between the September 2008 and December 2009. Immunological, virological, haematological and biochemical information was recorded for all patients selected. Analysis involved descriptive statistics, comparison of means, frequency analysis and multivariate analysis. Results: Two-hundred and thirty two patients were identified with elevated lactate levels in the retrospective study. The incidence was 6.2% in this population, with gastro-intestinal symptoms, peripheral neuropathy, abdominal tenderness, rash and upper respiratory tract infection being the significant symptoms. The major risk factor was a low CD4 count. The prospective study included 292 patients with 24.3% with Hlac/LA with peripheral neuropathy (p 0.209), gastrointestinal symptoms (nausea, vomiting) (p 0.148) and abdominal tenderness (p 0.214) were the most significant symptoms. In terms of the hypothesis that newer regimens would lower the incidence of elevated lactate levels by 50%, the observed incidence of 24.3% is no different from previously reported rates. This therefore shows that although regimen changes have been implemented the overall incidence of Hlac appears to be unchanged but the LA rate was found to be significantly lower than before, 6.8 cases per 1000 patient years vs ±19 cases per 1000 person years.(16) Gastro-intestinal symptoms but not peripheral iv neuropathy; with low CD4 count, weight loss and low weight on entry were the significant risk factors, which is most likely representative of advanced disease. Conclusions: Although newer regimens have been introduced, Hlac/LA still exist. Healthworkers need to be on high alert for Hlac/LA particularly if a patient enters into the ART program with a low CD4 count and a low weight

A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, in partial fulfillment of the requirements for the degree of Masters of Public Health in the field of Health Measurement 22nd February, 2012 / Introduction: Barriers associated with good adherence to Antiretroviral Therapy (ART) among human immunodeficiency virus (HIV) infected adolescents are multiple and complex. Those barriers contribute to low adherence levels putting infected adolescents at risk of developing resistance and decreasing their survival time. Patients care givers psychosocial and demographic variables, medication related factors and health care delivering factors are among the barriers that correlate with non adherence to antiretroviral drugs (ART’s) among HIV infected adolescents. Those barriers vary across individuals within the same population of adolescents. This study was conducted to determine the level of adherence among HIV infected adolescents on ART and to identify barriers associated with non adherence among this population attending the Botswana Baylor Children’s Clinical Center of Excellence (COE) in Gaborone, Botswana. Materials and methods: A cross sectional analytical study using quantitative data was performed. A structured, self administrated questionnaire adapted from the AIDS Clinical Trials Group (ACTG) was used to identify the barriers while the socio-demographic and clinical data were retrieved from study participants’ medical records. The adherence level was estimated using the pharmacy pill count technique. The adolescents aged 13 to 18 years receiving ART for more than 6 months and attending the ART National Program at the time of the study and who did assent and had their care givers consent to participate in the study were included in the analysis. Results: A high adherence level (75.6%) was reported among the study participants. Besides gender, no other socio-demographic and clinical variables showed association with non adherence. Male adolescents were found to be 70% less likely to adhere to their medication than their counterpart females [p= 0.020, OR=0.30, 95% CI (0.10 – 0.85)]. Furthermore adolescents v who missed a dose because their pills were not collected from the pharmacy either by themselves or by their care givers were 77 % less likely to adhere to their ART medication than those who did not miss a dose because they had their medication collected [p= 0.019, OR= 0.23, 95%CI (0.064 – 0.837)]. Conclusion: A high proportion of HIV infected adolescents attending the Baylor Center of Excellence ART National Program were adherent to their medication. Despite the high level adherence to ART among this age group, interventions to improve adherence level should be designed with a focus on male adolescents and to reinforce counseling of care givers and adolescents about the hazards of poor adherence to treatment. Further research is however, needed to elucidate more about the two main barriers that were found to be significantly associated with non adherence among adolescents at Botswana Baylor Children’s Clinical Center of Excellence: male-gender and medication collection from the pharmacy.

After 25 years of existence, the Human Immuno-deficiency Virus (HIV) has become a global challenge. Yearly, about 3 million people in the sub Saharan region become infected with the disease each year, while 2 million die of the disease. The young, sexually active and those in the economically active group are mostly affected although other categories are also affected. Over the years efforts have been made to turn HIV infection from a death sentence to a manageable chronic disease through the use of antiretro viral treatment (ART). Despite the fact that this treatment is a life-long commitment with adherence being crucial to its effectiveness, some patients still default. This research study sought to identify the characteristics of HIV positive patients who are lost to follow up after the initiation of antiretroviral treatment over a 2-year period (2007-2008). A tick sheet was used to collect data from all the files of patients lost to follow up and 20 variables were tested. The conclusion reached is that age, sex, distance of residence to the ART site and economic capability contribute to ‘lost to follow-up’.

Orientador: Henrique Luiz Monteiro / Banca: Ismael Forte Freitas Júnior / Banca: Sandra Lia do Amaral / Resumo: Após a introdução da terapia anti-retroviral altamente ativa (TARV), houve significativo aumento da sobrevida e melhora da qualidade de vida de indivíduos portadores de HIV, porém, esses tratamentos têm efeitos colaterais que podem causar transtornos para seus usuários, dentre os quais, a lipodistrofia. Além de causar um novo estigma estético para os portadores do vírus a síndrome pode elevar o risco de doenças cardiovasculares e diabetes. Nesse contexto, torna-se importante dar atenção a estratégias de prevenção e tratamento da síndrome. A atividade física pode ser uma alternativa válida para este fim, no entanto existem poucos estudos que tratam dessa temática. Desse modo, o objetivo do presente estudo foi verificar a possível associação entre o nível de atividade física e a ocorrência de lipodistrofia relacionada ao uso de terapia anti-retroviral em indivíduos portadores de HIV. A casuística foi formada por 42 indivíduos portadores de HIV em uso de TARV, todos pacientes do Centro de Testagem e Aconselhamento da cidade de Presidente Prudente. O nível de atividade física foi obtido pela aplicação do questionário internacional de atividade física (IPAQ), enquanto a lipodistrofia foi diagnosticada pela técnica de auto-relato do paciente... (Resumo completo, clicar acesso eletrônico abaixo) / Abstract: After the introduction of the Highly Active Antiretroviral Therapy (HAART), there was significant increase in survival and improved quality of life among HIV-infected individuals, however, these treatments have side effects that may cause inconvenience to its users, among which lipodystrophy is. Besides causing a new aesthetic stigma for those with the virus, the syndrome may increase the risk of cardiovascular disease and diabetes. In this context, it becomes important to pay attention to strategies for prevention and treatment of the syndrome. Physical activity may be a valid alternative for this purpose, however there are few studies that address this issue. Thus, the purpose of this study was to investigate the possible association between level of physical activity and lipodystrophy occurence related to the use of antiretroviral therapy in HIV-infected individuals. The sample consisted of 42 HIV patients under antiretroviral therapy, all patients of the Center for Counseling and Testing in the city of Presidente Prudente. The level of physical activity was achieved by using the international physical activity questionnaire (IPAQ), whereas lipodystrophy was diagnosed by the technique of self-report of the patient... (Complete abstract click electronic access below) / Mestre

Thesis(MSc(Med)(Pharmacy))--University of Limpopo (Medunsa Campus), 2011. / High levels of adherence to ART are essential for maximal suppression of viral replication and avoidance of drug resistance. Pill counts are an indirect, objective method of assessing adherence. Patients can invalidate pill counts by manipulating the number of tablets returned. This paper describes a pilot study which investigated the ability of ‘mixed’ pill counts to detect deliberate masking of non-adherence to ART at a public sector ARV Clinic in Pretoria, South Africa. Seventy-eight adult patients on a first line regimen of ART were recruited. At the first return visit, a standard pill count was performed and adherence (% of tablets taken) was calculated. For the repeat prescription, three days’ extra supply was dispensed without the patients’ knowledge. At the second return visit, a ‘mixed’ pill count was performed and adherence was calculated. Patients were grouped into three categories based on calculated adherence: truthfully non-adherent (<100% adherence), adherent (100% adherence) and ‘over-compliant’ (>100% adherence, i.e. returning to the clinic with fewer tablets than required). Exploratory interviews were conducted with truthfully nonadherent and over-compliant patients to obtain explanations for discrepancies in pill counts. Twenty-nine (37%) patients completed the study. Reasons for drop-out or discontinuation from the study included the issue of prescriptions for 2-3 months’ ARV supply, missed appointments, regimen changes and failure to return remaining tablets to the clinic. Eleven patients (38%) were identified as over-compliant in one or more of the ARVs in their regimen. Nine of these patients agreed to be interviewed, of which three admitted to manipulating their tablet numbers. Reasons for manipulation included: being ’fine now’ and not in need of ARVs; changes in body shape; possibility of the social grant being terminated if non-adherent; getting a new supply and no need for remaining ARVs; knowing that the tablets would be counted for the study. This pilot study indicated that the ‘mixed’ pill count method is capable of detecting deliberate masking of non-adherence. Applying this method to a larger sample may better estimate the frequency of pill count manipulation by patients and help gain insight to reasons for this behaviour and the extent of actual non-adherence. Key words: dumping, manipulation, masking, over-compliance, HAART