ACTG 128: A Randomized Blinded Trial to Evaluate the Safety and Tolerance of High Versus Low Dose Zidovudine Administered to Children with Human Immunodeficiency Virus (on Diskette)
(Englisch)
1996
Report
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This multicenter Phase III, two are, randomized, blinded trial was designed to evaluate the safety and tolerance of two oral dosing regimens of ZDV administered for 104 weeks to children with HIV infection as defined by specific inclusion criteria. Four hundred (400) childen three months to 12 years of age with HIV infection were enrolled into the protocol. The study was conducted on an outpatient basis. The diskette contains the anlaysis dataset for ATG-128. All participants were randomized to receive oral ZDV at a dose of eigher 180 mg/m2 or 90mg/m2 every six hours. The duration of therapy was 104 weeks. Children were prestratifid prior to randomization. As of 9/17/90, enrollment was limited to children < 6 years of age.
ACTG 128: A Randomized Blinded Trial to Evaluate the Safety and Tolerance of High Versus Low Dose Zidovudine Administered to Children with Human Immunodeficiency Virus (on Diskette)