The aim of pharmaceutical development is to design a quality product and the manufacturing process to deliver the product in a reproducible manner. The development of a new and generic formulation is based on a large number of experiments. Statistics provides many tools for studying the conditions of formulations and processes and enables us to optimize the same while being able to minimize our experimentation. The purpose of this study was to apply experimental design methodology (DOE) and multivariate analysis to the development and optimization of tablet formulations containing 150 mg lamivudine manufactured by direct compression.

Executive Function is conceptualized in this study as the ability to form (the planning functionality obtained through initiation and working memory), maintain (response selection and the ability to self-regulate and inhibit) and switch (cognitive flexibility, mental tracking, organization and sequencing) mental processes in order to effect a positive outcome. The present research is a quasi-experimental study embedded in the Positivist tradition that sets out to empirically evaluate the Executive Function profile of seropositive adolescents (n = 29) emerging from a low socio-economic background and currently on a managed ART programme when compared to a healthy contrast group (based on age, socio-demographic and educational system). As a quantitative study, Executive Function was operationalized through the use of multiple tests of Executive Function such as the Delis-Kaplan Executive Function Colour Word Interference Test (D-KEFS CWIT), the Wisconsin Card Sorting Test (WCST) and the Trail Making Test Part B (TMT-B). As the study formed part of a larger study that included additional neurocognitive tests, including the WISC-R, selected subtests from the WISC-R were used to validate specific arguments relating to the study. The results showed that HIV positive adolescents were inclined to have poorer Executive Function performance especially under situations of higher cognitive load when compared to the unaffected group. The implications of these results are discussed in this research.

In 2009 an estimated 33 million people were living with the Human Immunodeficiency Virus (HIV). Of this global population, 35% live in South Africa. Furthermore, sub-Saharan Africa is home to 80% of the world’s population of HIV-1 positive children and adolescents. The most prominent form of transmission of HIV in children in South Africa is from mother to child. Until 2004, South Africans had limited access to ARV treatment at and after birth due to the government legislation. As a consequence, treatment of HIV in children may only have been initiated after clinical presentation of immune deficiency. Therefore, currently, HIV-1 positive adolescents born during the period of restricted ARV-access may have experienced physical and developmental symptoms associated with the virus including neurological deficits, prior to initiating treatment. This study investigated the current psychomotor functioning, such as psychomotor speed, manual dexterity, graphomotor and visual-motor coordination of a group of low socio-economic HIV-1 positive adolescents in Johannesburg, South Africa, who are now on a managed antiretroviral programme and how this compared to a HIV negative contrast group. A Mann-Whitney U Test indicated a significant difference in mean non-dominant hand performance in the Grooved Pegboard Test between the two groups (U = 738, p < .05), with the HIV positive group performing slower than the HIV negative group. An independent samples t-test indicated a significant difference between groups in the Block Design subtest of the WISC-R [t(88) = -2.93, p < .01] where the HIV positive group performed significantly worse than the HIV negative group. Additionally, a Mann-Whitney U Test revealed a significant difference in number of errors made in the WISC-R Mazes subtest between groups (U = 736.50, p < .05), where the HIV negative group made more errors. Another Mann-Whitney U Test revealed a significant difference between groups in the ROCFT Copy score (U = 534.50, p < .01) where the HIV positive group achieved a significantly lower score than the HIV negative group. Lastly, a Mann-Whitney U Test demonstrated significant differences between the groups in the Trail Making Test A time (U = 445.00, p < .01), Trail Making Test B time (U = 509.00, p < .01), the number of errors made on the Trail Making Test B (U = 729.00, p < .05) and the difference between Trail Making Test B – A time (U = 769.50, p < .05) with the HIV positive group performing slower and making more errors in Part B than the contrast group. The findings of the current study imply that HIV-1 vertically-infected adolescents in Johannesburg, South Africa, on a delayed HAART programme appear to have persisting difficulties in complex psychomotor skills where an integration of functions is required. Furthermore, these results indicate an overall poor psychomotor performance in comparison to international normative data, supporting previous findings. Developmental, remedial and therapeutic recommendations were made.

South Africa has the most prominent percentage of individuals living with the Human Immunodeficiency Virus (HIV) in the world, with the most prominent form of transmission of HIV in South Africa being vertical mother-to-child transmission. From 1997 until 2004, South Africa had limited access to ARV treatment at and after birth due to the government legislation. As a consequence, treatment of HIV may only have been initiated after clinical presentation of immune deficiency. A paucity of information therefore exists regarding this population in addition to the specific age demographic of adolescents. Adolescents may be negatively influenced by the cortical thinning associated with HIV, and this study therefore aims to investigate the verbal fluency and vocabulary (in English) of 30 bi- or multilingual seropositive adolescents that are currently on a managed anti-retroviral programme in comparison to an HIV-negative contrast group of 70 bi- or multilingual adolescents in South Africa (matched for age, education, and socioeconomic status). The study found that there were no significant results between the HIV-positive and HIV-negative groups on the measures of vocabulary, semantic naming, or phonemic naming in ‘F’ as determined by their performance on the neuropsychological assessments. Significant results were noted between the HIV-positive and HIV-negative groups on the phonemic naming categories of ‘A’ and ‘S’ however, and negative correlations between performance in these categories and current viral load, and viral load at Highly Active Antiretroviral Therapy (HAART) initiation were also noted. This research formed part of a broader study examining the overall neurocognitive effects of HIV-1 infection in adolescents in South Africa.

Approximately 11.5 million Human Immunodeficiency Virus (HIV)-positive individuals were living in South Africa in 2007, many of whom were infected via mother-to-child transmission. The current study aimed to compare the attentional and concentration functioning of 30 seropositive adolescents on managed anti-retroviral (ARV) programmes, with a comparable group of 71 seronegative adolescents. The results showed that the uncorrected errors on trial 1; self-corrected errors on trial 2; time taken, uncorrected and self-corrected errors on trial 3 of the Stroop Colour-Word Interference Test; and the errors on the Trail Making Test Part B were significantly poorer in the seropositive sample. The results also indicated that the clinical variations in the HIV-positive sample, including the age at which ARVs were commenced; duration of ARV treatment; World Health Organisation (WHO) stage at diagnosis; starting and current CD4+ counts; and starting viral load, but with the exception of the current viral load, impacted significantly on test performance.

In 2007 it was reported that an estimated 33 million people worldwide were living with the Human Immunodeficiency Virus (HIV). Of this, 35% (approximately 11.5 million) live in South Africa, most of whom were infected with HIV by mother to child transmission. Due to government legislation, until 2004, South Africans had limited access to Antiretroviral (ARV) treatment at and after birth. As a consequence, treatment of HIV was, at this time, only in government facilities, initiated after the clinical presentation of immune deficiency. This study compared the memory functioning of low socio-economic seropositive adolescents that were on a managed anti-retroviral programme to that of a contrast group that were HIV negative. The groups were matched for age, gender, demographics and educational level. The relative impact of variables such as duration of ARV treatment, drug regimen, WHO stage at diagnosis and CD4+ count were all considered. Performance on a comprehensive neuropsychological battery was compared between the HIV positive group and their typically developing counterparts both in terms of memory functions as well as other cognitive processes that may have an effect on memory. The HIV positive group performed significantly below their HIV negative peers in processing speed, holistic processing, and spatial processing as well as specific visual functions such as visual constructional skills, visual recall ability, disruptions in both storage and retrieval of visuospatial information, and visual spatial working memory. No significant differences were found between the groups on tasks measuring verbal memory and verbal learning ability indicating that the neurocognitive profile of clade C HIV has a different presentation from the other clades. The findings suggest that the preferential effect HIV has on the frontostriatal circuits in the brain impacts memory processes due to the destructive impact of the virus on the myelination of these circuits. As a result of the higher degree of white matter tracts in the right hemisphere, holistic and integrative processing is impaired and visuospatial functions are affected whereas verbal processes are largely spared. The resulting neurocognitive profile is similar to that of nonverbal learning disorders and may benefit from similarly constructed interventions such as placing more emphasis on verbal learning strategies and limiting dependence on visual information for HIV positive pupils.

Introduction: While the antiretroviral (ARV) coverage has been scaled- up in the last 3 years in South Africa, there is limited data on the operating costs and financial sustainabihty of an anti- retroviral programme. Study Aim: To conduct a cost analysis of the stepdown ARV programme at the Kwadukuza Municipality Clinic (KMC) in the Ilembe district from a healthcare providers' perspective for the period 1st April 2005 to 31st March2006. Study Objectives: To determine the total costs and cost per patient per visit for outpatients attending the ARV, Wellness and VCT clinics respectively at KMC. Study Methods: Study location: This study was conducted at the Kwadukuza Municipality Clinic located in the Ilembe district in Kwazulu- Natal, South Africa. Study population: The population that is included in this study for the purposes of costing comprised: all the patients who received ARVs for the period under study; all the patients who attended the Wellness and VCT clinics and all the staff attached to the ARV programme at the KMC clinic Study design: This is a retrospective and cross- sectional study with both a descriptive and analytical component. Results: Seventy- one percent of the patients on ARVs were female with 50% of the patients being between 31 and 40 years of age. The total operating costs of running the ARV programme was R2 439 940- 90. The total cost accrued to the ARV clinic was R 1 698 003- 60. The Wellness clinic had a total cost of R 460 279- 68 and the VCT clinic accounted for the least total operating cost of R 281 657-77. The cost per patient visit was R440- 13 for the ARV clinic; R133- 05 for the VCT clinic and an amount of R61- 71 for the Wellness clinic. Conclusion This study provides the basis for determining the three cardinal cost components of the ARV programme, namely human resources, the cost of ARVs and the costs of viral load testing for the purposes of future planning and sustainability. The cost- effectiveness of ARV drugs can be improved if the healthcare providers negotiate a lower price for these drugs. The high cost due to monitoring tests can be lowered by decreasing the frequency of these tests but this may allow ARV drug resistance to be undetected. / Thesis (M.Med.)-University of KwaZulu-Natal, Durban, 2008.

RN/AIDS has had a particularly devastating effect on sub-Saharan nations, including South Africa. Thus, a national rollout of antiretroviral drugs - capable of mitigating the effects of the epidemic - has been vigorously demanded by the South African public. Eventually bowing to public pressure, the Government began to implement the rollout of the drugs at public health facilities in early 2004. The University of KwaZulu-Natal announced in 2004 that it too would provide access to antiretroviral drugs for all students who require them. Thus, there is an urgent need for the institution to develop promotional campaigns that not only promote the service but that also deal with the fall-out from the problematic national rollout, and that address the complicated nature of antiretroviral therapy. The focus of this dissertation is on a promotional needs analysis for the antiretroviral rollout at the University. Specifically, the primary research aimed to determine the knowledge, attitudes and beliefs of the general student population on the topic of antiretrovirals, and by doing so, identify the needs of this audience that will have to be addressed by future promotional campaigns. The theoretical framework used to inform the research design and questions is that of social marketing; a relatively new approach to social change that uses principles of commercial marketing to achieve results among target audiences. The results of the research suggest that future promotional messages and campaigns directed at the general student population will need to focus on the following issues: clarifying the distinctions between different contexts of ARV use; increasing the awareness of the rollout at UKZN as a prerequisite to stimulating demand; addressing negative beliefs and misconceptions regarding ARVs; emphasising complementary practices to be used by individuals with RN/AIDS; addressing issues of stigma and discrimination and encouraging students to act as sources of support and information for other students. In the case of certain messages, segmentation - on the basis of race and campus - may result in a more effective dissemination of information to the target audiences. / Thesis (M.Soc.Sc.)-University of KwaZulu-Natal, 2005.

The Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) is one of the leading chronic diseases affecting people in South Africa and throughout the world. This study aimed to investigate the effect disclosure of HIV status had on antiretroviral therapy (ART) adherence. A convenience sample of 65 HIV positive adult patients currently taking ART at a public Primary Health Care (PHC) clinic in the Nelson Mandela Metropole was selected. Participation was voluntary and confidentiality was maintained at all times. Data was collected using three tools/techniques: (1) a Patient Questionnaire (PQ) to extract information on patient's demographics, HIV disclosure status, regimen the patient was on and self-reported adherence to ART; (2) an audit of a Patient Medical Record (PMR) for information on the regimen the patient was on, the period during which the patient had been on ART medication, the adherence to ART care and the level of the patient‟s biological markers; and (3) Pill Counts (PC) performed on the patient's medical supply to validate the self-reported adherence to ART. There was no significant relationship between the disclosure of HIV status and adherence to ART (p= 0.59; Chi²). However, the relationship between the adherence to ART and increase in the CD4 count levels of patients on ART in this population was significant (p=0.03; Chi²). It can be concluded that no direct relationship was found between the disclosure of HIV status and adherence to ART in this population. However, several factors affected the reasons and decisions of individuals to disclose their HIV status and this influenced their daily taking of medication.

This study aimed to explore and describe the quality of life of adolescents living with early childhood HIV infection on Highly Active Antiretroviral Therapy (HAART) in Port Elizabeth. The advent of HAART has resulted in HIV being managed as a chronic illness, instead of the fatal disease that it once was. Children born with HIV can now live longer lives, progressing to adolescence and beyond. Chronic illness is known to impact one’s quality of life, so does adolescent development. A convenient sample of 31 adolescents was used in this study, with an exploratorydescriptive research design. The data was gathered using a cross cultural structured questionnaire developed by the World Health Organization, as well as through individual interviews. The data was then analysed by means of descriptive statistics and thematic content analysis. The results identified and presented the quality of life issues that are specific to this population. The results indicate that HIV as a chronic illness does impact the quality of life of adolescents. The adolescents living with early childhood HIV-infection on HAART in this study were very satisfied with their perceptions of their overall quality of life and general health perceptions. They were least satisfied in the Spirituality/Religion/Personal Beliefs and Social Relationships domains; and were most satisfied in the Level of Independence and the Psychological domains. There is a need for the development of (medical and psychosocial) services that can focus on adolescents as a special population with specific developmental needs in order to improve their treatment outcomes and quality of life.