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Attrition of HIV-infected individuals not yet eligible for antiretroviral treatment: do we care?
No full textObtaining valid laboratory data in clinical trials conducted in resource diverse settings: lessons learned from a Microbicide Phase III Clinical Trial
No full textBACKGROUND: Over the last decade several phase III microbicides trials have been conducted in developing countries. However, laboratories in resource constrained settings do not always have the experience, infrastructure, and the capacity to deliver laboratory data meeting the high standards of clinical trials. This paper describes the design and outcomes of a laboratory quality assurance program which was implemented during a phase III clinical trial evaluating the efficacy of the candidate microbicide Cellulose Sulfate 6% (CS) [1]. METHODOLOGY: In order to assess the effectiveness of CS for HIV and STI prevention, a phase III clinical trial was conducted in 5 sites: 3 in Africa and 2 in India. The trial sponsor identified an International Central Reference Laboratory (ICRL), responsible for the design and management of a quality assurance program, which would guarantee the reliability of laboratory data. The ICRL provided advice on the tests, assessed local laboratories, organized trainings, conducted supervision visits, performed re-tests, and prepared control panels. Local laboratories were provided with control panels for HIV rapid tests and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) amplification technique. Aliquots from respective control panels were tested by local laboratories and were compared with results obtained at the ICRL. RESULTS: Overall, good results were observed. However, discordances between the ICRL and site laboratories were identified for HIV and CT/NG results. One particular site experienced difficulties with HIV rapid testing shortly after study initiation. At all sites, DNA contamination was identified as a cause of invalid CT/NG results. Both problems were timely detected and solved. Through immediate feedback, guidance and repeated training of laboratory staff, additional inaccuracies were prevented. CONCLUSIONS: Quality control guidelines when applied in field laboratories ensured the reliability and validity of final study data. It is essential that sponsors provide adequate resources for implementation of such comprehensive technical assessment and monitoring systems. TRIAL REGISTRATION: ClinicalTrials.gov NCT00153777 and Current Controlled Trials ISRCTN9563838
Fumonisin exposure through maize in complementary foods is inversely associated with linear growth of infants in Tanzania
No full textInfants consuming maize-based foods are at a high risk of exposure to fumonisins. This study explored the association between exposure of fumonisins from maize and growth retardation among infants in Tanzania. Mothers of 215 infants consented for their children to participate in this study. We estimated maize intake for each child by twice conducting a 24 h dietary recall and fumonisins level in the maize, using HPLC. Fumonisins exposure for each child was estimated by combining his/her maize intake and the fumonisins level in the maize. Of the infants, 191 consumed maize. The maize consumed by 131 infants contained fumonisins at levels varying from 21 to 3201 mug/kg. Fumonisins exposure in 26 infants exceeded the provisional maximum tolerable daily intake of 2 mug/kg body weight. At 12 months of age, infants exposed to fumonisins intakes above the provisional maximum tolerable daily intake of 2 mug/kg bodyweight were significantly shorter by 1.3 cm and 328 g lighter. It appears that the exposure to fumonisins is associated with growth retardation. This is the first study to report an association between fumonisins exposures and growth retardatio
Performance of abdominal ultrasound for diagnosis of tuberculosis in HIV-infected persons living in Cambodia
No full textBACKGROUND:: In resource-limited settings, abdominal ultrasound is often used to assist the diagnosis of tuberculosis (TB) in people with HIV (PLHIV), although data on performance characteristics are missing. METHODS:: Cross-sectional study of PLHIV in Cambodia receiving a standardized TB diagnostic evaluation, including history, physical examination, chest radiography, microscopy and culture of various specimens, and abdominal ultrasound. Patients with at least one specimen culture positive for Mycobacterium tuberculosis were classified as having TB. RESULTS:: TB was diagnosed in 37 (18%) of 212 PLHIV. Abdominal ultrasound was abnormal in 15 of 37 (41%) patients with TB compared with 14 of 175 (8%) without TB (P < 0.01). Predictors of TB disease included multiple enlarged (1.2 cm or greater) abdominal lymph nodes on ultrasound (adjusted odds ratio [OR], 6.4; 95% confidence interval [CI], 1.8-22.4), abnormal chest radiography (OR, 6.8; CI, 2.7-17.0), anorexia (OR, 4.6; CI, 1.8-11.7), and CD4 less than 200 cells/mm (OR, 3.3; CI, 1.2-9.1). Having multiple enlarged abdominal lymph nodes on ultrasound was 97.1% (CI, 93.5%-99.1%) specific for TB with a positive likelihood ratio of 11.4 (CI, 4.3-30.3). CONCLUSIONS:: Abdominal ultrasound is a useful diagnostic test for TB disease in PLHIV, increasing the posttest probability of TB when multiple enlarged abdominal lymph nodes are visualized. Its wider use may accelerate access to TB treatment, potentially reducing mortality in PLHI
Trypanosoma evansi: recent outbreaks in Europe
No full textHere, two recent outbreaks of Trypanosoma evansi infection in mainland France and Spain associated with the importation of dromedary camels from the Canary Islands, are reported. The disease is well-known on the Archipelago since 1997 and many efforts have been made towards control and eventual eradication, but some areas still remain affected. Both mainland outbreaks were controlled by means of massive treatments and monthly serological, parasitological and molecular (PCR) evaluations carried out by Valencian Regional Animal Health laboratory and by CIRAD, Montpellier, respectively. Possible causes for the persistence of the parasite in a small area of the Canaries are discussed. T. evansi must be included among the animal health conditions for international trade within the European Union as well as many other countries. Moreover, procedures including diagnosis, curative or preventive treatment and quarantine should be established to insure the status of the animals moving from a country to anothe
Low frequency of liver enzyme elevation in HIV-infected patients attending a large urban treatment centre in Uganda
No full textLiver enzyme elevations among patients on antiretroviral therapy (ART) were determined by prospectively evaluating aspartate aminotransferase (AST) data in a cohort of patients in Kampala over 36 months. A proportion of patients had hepatitis B virus (HBV) status determined. Hepatotoxicity was graded I to IV according to the AIDS Clinical Trial Group criteria. Of 546 patients, 377 (69%) were women; overall median baseline CD4+ T-cell was 97/muL (interquartile range [IQR] 20-164). Hepatitis B surface antigen (HBsAg) was detected in 42 (9%) of 470 persons. ART included lamivudine, with either nevirapine and d4T (74%) or efavirenz and AZT (26%). Median (IQR) AST level at baseline was 35 (27, 53 IU/L). Over 36 months, only eight patients had grade III AST elevation. Neither HBsAg nor ART regimen influenced AST levels. Male gender and CD4+ change from baseline were correlated with AST elevation. Patients with HIV/HBV co-infection were not at an increased risk of AST elevation, which occurred uncommonly in this settin
Socio-economic aspects of neglected diseases: sleeping sickness and visceral leishmaniasis
No full textSeveral tropical diseases that are essentially poverty-related have recently gained more attention under the label of 'neglected tropical diseases' or NTD. It is estimated that over 1000 million people currently suffer from one or more NTD. Here, the socio-economic aspects of two NTD - human African trypanosomiasis and human visceral leishmaniasis - are reviewed. Both of these diseases affect the poorest of the poor in endemic countries, cause considerable direct and indirect costs (even though the national control programmes tend to provide free care) and push affected households deeper into povert
Negative staining technique of Heine for the detection of Cryptosporidium spp.: a fast and simple screening technique
No full textManagement of pulmonary tuberculosis patients in an urban setting in Zambia: a patient's perspective
No full textBACKGROUND: Zambia continues to grapple with a high tuberculosis (TB) burden despite a long running Directly Observed Treatment Short course programme. Understanding issues that affect patient adherence to treatment programme is an important component in implementation of a successful TB control programme. We set out to investigate pulmonary TB patient's attitudes to seek health care, assess the care received from government health care centres based on TB patients' reports, and to seek associations with patient adherence to TB treatment programme. METHODS: This was a cross-sectional study of 105 respondents who had been registered as pulmonary TB patients (new and retreatment cases) in Ndola District between January 2006 and July 2007. We administered a structured questionnaire, bearing questions to obtain individual data on socio-demographics, health seeking behaviour, knowledge on TB, reported adherence to TB treatment, and health centre care received during treatment to consenting respondents. RESULTS: We identified that respondents delayed to seek treatment (68%) even when knowledge of TB symptoms was high (78%) or when they suspected that they had TB (73%). Respondent adherence to taking medication was high (77%) but low adherence to submitting follow-up sputum (47%) was observed in this group. Similarly, caregivers educate their patients more often on the treatment of the disease (98%) and drug taking (100%), than on submitting sputum during treatment (53%) and its importance (54%). Respondent adherence to treatment was significantly associated with respondent's knowledge about the disease and its treatment (p < 0.0001), and with caregiver's adherence to treatment guidelines (p = 0.0027). CONCLUSIONS: There is a need to emphasise the importance of submitting follow-up sputum during patient education and counselling in order to enhance patient adherence and ultimately treatment outcom