This is a Phase II/III comparative, multi-center trial of symptomatic HIV-1-infected children comparing the efficacy of lamivudine plus zidovudine vs. didanosine monotherapy vs. zidovudine plus didanosine. Results are determined by HIV disease progression based on time to development of first new CDC category C diagnoses, death, failure to achieve adequate weight growth velocity, or decline in neurological or neuropsychological assessments. This study was officially closed at Cincinnati in June 1997. The loss of NIH funding meant that our institution was in a close-out phase of the study for the first four months of 1997. No publications have as yet resulted from this trial. All patients who were previously enrolled in the ACTG trial at Cincinnati Children's Hospital were transferred to Columbus Children's Hospital, which remains a member of the ACTG.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR008084-06S1
Application #
6122856
Study Section
Project Start
Project End
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
6
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Cincinnati Children's Hospital Medical Center
Department
Type
DUNS #
071284913
City
Cincinnati
State
OH
Country
United States
Zip Code
45229
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