Objective
PENTA (Paediatric European Network for Treatment of AIDS) was established and funded by the EC in 1990 to build a network of paediatric centres to undertake multicentre clinical trials to address therapeutic questions specific to HIV infection in children. Co-ordination of the PENTA Trials has been set up through the MRC and ANRS HIV Clinical Trials Centres, which co-ordinate trials in adults with HIV infection
The PENTA 1 trial, a randomised double blind multicentre phase III trial to evaluate the use of zidovudine (ZDV, azidothymidine, AZT), in asymptomatic or early symptomatic HIV infection in children (born to HIV antibodies positive mother's), started in 1992. When the results of Delta and ACTG 175 trials became available (Sept. 95) we decided to end the blind phase of the trial. However we will continue to follow up children previously enrolled and delay analysis of trial date. In Autumn 1994 a second randomised double-blind phase 11 trial, PENTA 3, comparing the combination of ZDV plus zalcitabine (dideoxycytidine, ddC) with ZDV monotherapy in symptomatic children who had not taken antiretroviral therapy before commenced. A third double blind phase 11 trial, PENTA 4, comparing ZVD plus 3TC (-2'-deoxy-3'-thiacytidine, lamivudine) with ZDV monotherapy in children previously treated with antiretroviral therapy is in an advanced stage of planning. Other new projects involving PENTA include a European project which is evaluating the interventions in reducing the rate of HIV transmission from mother to child, and long-term surveillance of children exposed to zidovudine in utero, during delivery and neonatal period.
Topic(s)
Call for proposal
Data not availableFunding Scheme
CON - Coordination of research actionsCoordinator
35128 Padova
Italy