ATTEMPTING TO ENHANCE THE ENROLLMENT OF ADOLESCENTS INTO AIDS CLINICAL-TRIALS - THE DESIGN OF ACTG-PROTOCOL-220

The epidemic of HIV infection continues to grow in adolescents and you ng adults. Unfortunately, because treatment regimens have been develop ed based on data derived from clinical trials, little data are availab le on adolescents because they are infrequently included in these tria ls. In an effort to facilitate the enrollment of more adolescents into AIDS Clinical Trials Group (ACTG) clinical trials, we designed a nont reatment protocol to familiarize adolescents with clinical trials requ irements. Two hundred fifty-six adolescents (150 females, 106 males) b etween the ages of 13 and 21 years were enrolled at 43 different clini cal trials sites throughout the United States. The majority of patient s (50%) were enrolled at sites that had specific programs for adolesce nts. Most of the young women (85%) had acquired their infection via he terosexual transmission, whereas the largest transmission categories i n men were blood or factor transfusions (43%) or same-sex contact (34% ). Admission CD4 counts were lower in males (mean = 396 cells/mm(3)) t han in females (mean = 513 cells/mm(3)) (p = 0.01). Psychosocial profi les revealed a variety of ongoing risk behaviors in HIV-infected adole scents. Two years into the study, 223 patients are still being observe d. We conclude that adolescents can be enrolled in an observational pr otocol. The success of this trial will be determined by how many ACTG Protocol 220 participants are ultimately enrolled in therapeutic trial s.