Second International Congress Drug Therapy in HIV Infection 18-22 November 1994 Glasgow, UK

CLINICAL TRIAL ISSUES IN CHILDREN

Dott. Carlo Giaquinto
Department of Pediatrics - Via Giustiniani 3 - 35128 Padova - Italy

Int Cong Drug Therapy HIV 1994 Nov 18-22;2:Abstract No. 14.3
AIDS 1994, Vol. 8 (Suppl. 4);S12

Results from adults trial on antiretroviral drugs are not directly applicable in children. In fact HIV infection in pediatric population differs from adults for several reasons:

- the mode of infection (perinatal)

- disease progression (about 40% of children born to HIV positive mothers develop AIDS by 5 years of age)

- natural history (Kaposi Sarcoma is very rare In pediatric patients whereas bacterial infections are more common)

- immunological maturity (CD4 counts are not very useful as progression markers in children)

- different ethology of infections. (CMV is common)

Although zidovudine remains the drug of choice in children there have been no placebo-controlled trials in pediatric population and there are still doubts on when to start treatment. Recently in Europe a trial (PENTA-1) was set up aiming to compare immediate and deferred (until symptomatic disease) use of zidovudine. So far about 180 HIV infected children have been recruited in 10 countries. results from this study will be very important to gather information about the benefits and risks of early zidovudine in children.

Several phase I-II trials on combination therapy are ongoing in children however the lack of adequate drug formulation may cause problems for their use in children.

Presenting author: Dott. Carlo Giaquinto

1994-11-18
14.3

Originally published in AIDS Volume 8, Supplement 4 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701

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