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5. Five year follow up of vertically HIV infected children in a randomised double blind controlled trial of immediate versus deferred zidovudine: the PENTA 1 trial

Author

Aboulker, J. P., Babiker, A., Darbyshire, J. H., Debre, M., Giaquinto, C., Gibb, D. M., Harper, L., Newberry, A., Saidi, Y., Levy, J., Della Negra, M., Forbes, J., Vaudry, W., Mechinaud, F., Nicolas, J., Wahn, V., Dammann, C., Notheis, G., Hinkelmann, B., Butler, K., De Manzini, A., Mazza, A., Duse, Marzia, Loy, A., Plebani, A., Castelli Gattinara, G., Cellini, M., Palomba, E., Caselli, D., Guarino, A., Osimani, P., Scherpbier, H., Delgado, A., Gomez, I. D., Lecuona, J. E., Pena, M. J. M., Baselga, C., Leal, J. A. L., Amador, J. T. R., Canosa, C., Sierra, A. M., Calavia, L. C., Rodrigo, C., Guasch, C. F., Bohlin, A., Nadal, D., Mok, J., Lyall, H., Novelli, V., Sharland, M., Sloper, K., J., Levy, M., Della Negra, J., Forbe, W., Vaudry, F., Mechinaud, J. Nicolas V., Wahn, C., Dammann, G., Nothei, B., Hinkelmann, K., Butler, C., Giaquinto, A., De Manzini, A., Mazza, M., Duse, A., Loy, A., Plebani, G., Castelli Gattinara, M., Cellini, E., Palomba, D., Caselli, Guarino, Alfredo, P., Osimani, H., Scherpbier, A., Delgado, I., De José Gomez, J., Echeverria Lecuona, MJ Mellado, Pena, C., Baselga, J. A., Leon Leal, J. T., Ramos Amador, C., Canosa, A., Mur Sierra, L., Ciria Calavia, C., Rodrigo, C., Fortuny Guasch, A., Bohlin, D., Nadal, J., Mok, H., Lyall, V., Novelli, M., Sharland, and K. S. l. o. p. e., R.

Subjects
Male, medicine.medical_specialty, Pediatrics, Adolescent, Anti-HIV Agents, Human immunodeficiency virus (HIV), HIV Infections, medicine.disease_cause, Statistics, Nonparametric, aids, hiv, penta, placebo-controlled, randomised, zidovudine, law.invention, Double blind, Zidovudine, Double-Blind Method, Randomized controlled trial, Acquired immunodeficiency syndrome (AIDS), law, Humans, Medicine, Child, Proportional Hazards Models, Reverse Transcriptase Polymerase Chain Reaction, business.industry, Five year follow up, Infant, Viral Load, Flow Cytometry, medicine.disease, Infectious Disease Transmission, Vertical, CD4 Lymphocyte Count, Surgery, Area Under Curve, Child, Preschool, Pediatrics, Perinatology and Child Health, Disease Progression, HIV-1, General and Specialist Paediatrics, Female, business, Follow-Up Studies, medicine.drug
Abstract

A total of 195 children were randomised to zidovudine (immediate) or matching placebo (deferred) in a multicentre double blind trial in vertically HIV infected children with early disease (the PENTA 1 trial). Median follow up in the blinded phase was 1.9 years. Thereafter, individual children were unblinded following the results of adult trials showing a benefit of combination antiretroviral therapy (ART) over monotherapy, but follow up continued and is reported here until December 1998 (total follow up 4.6 years). Median time to starting ART in the deferred group was 2.7 years; 19% of deferred children had not started ART by 1999. Throughout follow up, the percentage of time spent on no ART, monotherapy, dual, and triple ART was 21%, 44%, 29%, and 6% respectively for immediate and 62%, 12%, 18%, and 8% for deferred groups. During the blinded phase eight (7.8%) immediate and 12 (13.3%) deferred children developed AIDS or died (log rank p = 0.24); overall 21 immediate and 20 deferred children progressed. In an analysis including all children regardless of original allocation, the risk of progression to AIDS or death, adjusting for age and time since trial entry was significantly lower during 1997-98 (2.4 per 100 child years) than during 1992-96 (6.6 per 100 child years), most likely a result of increased use of combination ART.

Published
2001

18. Early markers of the renal complications of insulin dependent diabetes mellitus.

Author

GIBB, D. M., DUNGER, D., LEVIN, M., SHAH, V., SMITH, C., BARRAIT, T. M., and Barratt, T M

Abstract

We investigated the associations between albuminuria, metabolic control, glomerular filtration, blood pressure, and platelet function in children with insulin dependent diabetes mellitus. The geometric mean (95% tolerance levels) albumin excretion (expressed as the geometric mean albumin to creatinine ratio on two overnight urine collections (UA/UC], in 60 diabetic children was 0.72 (0.80-6.9) mg/mmol, significantly greater than in 45 normal children (geometric mean 0.41 (0.14-1.17]. Mean (SD) glomerular filtration rate, measured by 51Cr edetic acid clearance during constant infusion, was significantly greater in diabetic children (129 (20) ml/min/1.73 m2) compared with normal controls (109 (13]. Mean (SD) renal length for height standard deviation score was +0.25 (1.1); systolic blood pressure standard deviation score was 0.15 (0.65), and diastolic blood pressure was 0.51 (0.82). Spontaneous platelet aggregation, expressed as percentage fall in platelet count in stirred whole blood after 2 minutes was 17.8 (9.2)% in the diabetic compared with 12.3 (7.9)% in normal children. UA/UC correlated with renal length and of the children with UA/UC above the normal range, 70% also had a glomerular filtration rate above the normal range. There was a weak correlation between UA/UC and glycated haemoglobin (HbA1c). All children with spontaneous platelet aggregation above normal had had diabetes for more than seven years. These cross sectional data define some of the early markers and inter-relationships that may be important in the development of nephropathy. [ABSTRACT FROM AUTHOR]

Published
1989

19. Renal tubular proteinuria and microalbuminuria in diabetic patients.

Author

GIBB, D. M., TOMLINSON, P. A., DALTON, N. R., TURNER, C., SHAH, V., and BARRATT, T. M.

Abstract

The urinary extraction of albumin, retinol binding protein, and N-acetyl-beta-D-glucosaminidase were studied in 60 children with insulin dependent diabetes mellitus and in 45 normal children to find out whether the renal tubules played a part in causing the early increase in urinary excretion of albumin that occurs in diabetes mellitus. Two overnight urine samples were collected and the protein excretion measured and expressed as the geometric mean of the protein to creatinine ratio (urinary albumin:creatinine ratio, urinary retinol binding protein:creatinine ratio, and urinary N-acetyl-beta-D-glucosaminidase:creatinine ratio, respectively). The excretion of all three proteins was significantly higher in the diabetic children with 15 (25%) of urinary albumin:creatinine ratio, 16 (27%) of urinary retinol binding protein:creatinine ratio, and 43 (72%) of urinary N-acetyl-beta-D-glucosaminidase:creatinine ratio values being above the normal range. Significant correlations were observed between urinary albumin:creatinine ratio and urinary retinol binding protein:creatinine ratio, urinary albumin:creatinine ratio and urinary N-acetyl-beta-D-glucosaminidase:creatinine ratio, and urinary retinol binding protein:creatinine ratio and urinary N-acetyl-beta-D-glucosaminidase:creatinine ratio. There were also significant correlations between glycated haemoglobin 1c (HbA1c) and these proteins, especially N-acetyl-beta-D-glucosaminidase. No correlations were observed with the fractional excretion of sodium, flow rate of urine, glomerular filtration rate, or blood pressure. These data show that tubular abnormalities are present early in the course of insulin dependent diabetes mellitus and suggest that the early increase in urinary excretion of albumin may be at least partly tubular in origin, and that glycaemic control may influence this aspect of proximal tubular function. [ABSTRACT FROM AUTHOR]

Published
1989
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20. G265(P) Gastroenteritis aggressive versus slow treatment for rehydration (gastro study): a descriptive analysis

Author

Houston, K, Gibb, J, Mpoya, A, Obonyo, N, Olupot-Olupot, P, George, E, Gibb, D, and Maitland, K

Abstract

AimsThe World Health Organisation (WHO) rehydration guidelines (Plan C) for children with acute gastroenteritis (AGE) and severe dehydration are widely practiced in resource-poor settings, yet have never been evaluated in a clinical trial. GASTRO study will compare the safety and efficacy of two rehydration regimens: standard rapid rehydration (Plan C) versus a slower regimen and inform definitions for outcomes of a larger phase III trial.MethodsGASTRO is a multi-centre, open Phase II randomised controlled trial of 120 children aged 2 months to 12 years admitted with severe dehydration secondary to AGE. Children with severe malnutrition, chronic diarrhoea and known congenital/rheumatic heart disease are excluded. Children are enrolled in 3 centres in East Africa and randomised 1:1 to standard rapid rehydration (WHO plan ‘C’ – 100 mls/kg over 3–6 hours according to age, plus additional boluses for children presenting in shock) or to a slower rehydration regimen (100 mls/kg given over 8 hours and without additional boluses). Primary outcome is frequency of adverse events. Secondary outcomes focus on measures related to assessment of severity of dehydration, and response to treatment.ResultsEnrolment is ongoing. By 21 st September 2017 61 children had been enrolled. Baseline characteristics across the two groups are consistent: median age 9 months (IQR 7–14), 67% males, median duration of diarrhoea and vomiting is 3 days, the majority are lethargic, thirsty and irritable on admission (70%) and main features of dehydration are sunken eyes (100%), prolonged skin pinch (64%), reduced/absent tears (100%), dry/sticky mucous membranes (98%). Features of shock (cool peripheries, weak and fast pulse, and prolonged capillary refill) exist in 33% of the patients at admission, and no child had severe hypotension. Median weight loss is 5.7%. We have not completed recruitment and therefore cannot present outcomes at this stage.DiscussionThere have been two main challenges when operationalising this trial. Firstly staff training and confidence with ensuring accurate fluid balance documentation. Secondly there has been slow recruitment as a result of national medical strikes and a severe drought across East Africa resulting in higher numbers of children fulfilling severe malnutrition anthropometric criteria and therefore being excluded.

Published
2018
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