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ACTG 152: A randomized comparative trial Of zidovudine (ZDV) vs didanosine (DDI) vs combination ZDV+DDI in symptomatic HIV-infected children.
Englund JA; Baker CJ; McKinney RE Jr; Raskino CL; Schoenfeld DA; Petrie
November 30, 1996
3rd Conf Retro and Opportun Infect. 1996 Jan 28-Feb 1;:173. Unique

ACTG 152 was designed to compare safety, tolerance, and efficacy of ZDV(180 mg/m(2) and 90 mg/m(2)) in symptomatic HIV-infected children, ages 3 mo.-8 yr., who had less than or equal to 6 wks antiretroviral therapy. Patients were stratified by age less than or greater than or equal to 30 mos. The primary endpoint of the trial was time to death or first HIV disease progression, defined as growth failure, greater than or equal to 2 opportunistic infections, or 2 of the following: neuropsychological deterioration or neurologic deterioration or decreased brain growth. This study closed to accrual on 8/31/93 after 839 pts. were enrolled. Interim analysis on 2/8/95 at median followup of 24 months revealed that 21% of all pts. had reached primary endpoint. Significantly more pts. receiving ZDV monotherapy reached endpoint compared with the best of the other two therapies. Estimated relative risk for best treatment arm vs ZDV in children less than 30 mos. was 0.54 (95% Cl= 0.35-0.83) and for greater than or equal to 30 mos. was 79 (95% Cl = 0.41-1.54). Significantly higher hematological and chemical toxicities were also noted in this arm. Pts. receiving ZDV were unblinded in Feb. 1995; those randomized to the remaining therapies continued until study closure on 8/30/95. Final analysis of this study is underway.

Antiviral Agents/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Child Child, Preschool Didanosine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Drug Therapy, Combination HIV Infections/COMPLICATIONS/*DRUG THERAPY/PHYSIOPATHOLOGY Human Infant Zidovudine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE ABSTRACT

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