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EUROPEAN NETWORK FOR CLINICAL TRIALS IN HIV INFECTED CHILDREN

Objective

The overall objectives of PENTA are:
- The creation of an European paediatric network where clinical trials on AIDS therapeutics can be conducted.
- To create uniform standards throughout the EEC for treatment of children infected with HIV.
- To establish uniform therapeutic procedures for new-borns of HIV infected mothers to reduce the rate of infection.
- To establish uniform technical procedures for early diagnosis and treatment of symptomatic children.
- To establish uniform parameters for prognosis of HIV infection specially for neurological manifestations in order to adapt the therapeutical strategies.
The Paediatric European Network for Treatment of acquired immune deficiency syndrome (AIDS) (PENTA) was formed in 1990 with the aim of providing greater cohesion among paediatric human immunodeficiency virus (HIV) research and treatment centres throughout Europe. This has been accomplished through the development of several HIV protocols which will be initiated through 1994. The PENTA I trial Early versus deferred use of zidovudine (ZDV) in children with HIV infection born to HIV antibody positive mothers has started and continues to recruit patients. The Penta I protocol has enabled the network to standardise its statistical procedures, some therapeutic protocols and written forms. PENTA II is a randomized comparative trial of 2', 3' dideoxyinosine (ddI) versus ZDV plus ddI in HIV infected children previously treated with ZDV which will benefit directly from the ground work of PENTA I. Both tolerance and pharmacokinetic studies on ddI were done prior to the approval of the PENTA II project. The PENTA III study is a phase II trial comparing toxicity and tolerability of ZDV alone with ZDV and dideoxycystidine ddC in symptomatic antiretroviral naive infected children. It is due to start in early 1994 with a planned intake of 100 children.
The Paediatric European Network for Treatment of AIDS (PENTA) was formed in March 1990 with the aim of providing greater cohesion among paediatric HIV research and treatment centres throughout Europe. This has been accomplished through the development of several HIV protocols.

PENTA I trial 'Early versus deferred use of Zidovudine in children with HIV infection (born to HIV antibody positive mothers)' has started and continues to recruit patients. Based on this protocol, which will continue for three years, the PENTA organisation was able to launch satellite interest groups which are directly relevant to the PENTA network: PENTA virologist group and PENTA-BRAIN.
The Penta I protocol has also enable the network to standardise its statistical procedures, some therapeutic protocols and written forms. Considering the great diversity of regulation that exist among the European countries, this represents a considerable accomplishment.

PENTA II a randomised comparative trial of 2',3' Dideoxyinosine (ddI) versus Zidovudine (ZDV) plus ddI in HIV infected children previously treated with ZDV will benefit directly from the ground work of PENTA I. We anticipate that PENTA II will begin recruitment and be operative much more quickly if an access to a AZT placebo is possible than the first protocol. Both tolerance and pharmacokinetic studies on ddI were done prior to the approval of the PENTA II project.

PENTA III study is a phase II trial comparing toxicity and tolerability of ZDV alone with ZDV and Dideoxycystidine (ddC) in symptomatic antiretroviral naive infected children. It is due to start in early 1994 with a planned intake of 100 children.

Coordinator

Hôpital Necker - Enfants Malades
Address
149 Rue De Sèvres
75743 Paris
France