A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.

In Stage 1 of the study, a minimum of 22 patients are randomized to each of three treatment arms: didanosine (ddI) plus AZT plus nevirapine (NVP); ddI plus AZT; and ddI plus NVP. After 12 weeks of treatment, the study proceeds to Stage 2 provided at least 40 percent of patients in Stage 1 show a reduction of at least 40 percent from baseline ICD p24 antigen of greater than or equal to 70 pg/ml AND fewer than two patients experience grade 4 rash. Patients in Stage 1 continue treatment for an additional 36 weeks. In Stage 2, additional patients are randomized to each original treatment regimen until a maximum of 130 patients per arm have been entered. Stage 2 patients receive treatment for at least 48 weeks.

AS PER AMENDMENT 02/12/97: As of 2/28/97, patients receiving study drugs will be offered blinded study drugs for an additional 16 weeks (until 6/30/97). Patients will be unblinded on or about 5/23/97.