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 young adults. Unfortunately, because treatment regimens have been developed based on data derived from clinical trials, little data are available on adolescents because they are infrequently included in these trials. In an effort to facilitate the enrollment of more adolescents into AIDS Clinical Trials Group (ACTG) clinical trials, we designed a nontreatment protocol to familiarize adolescents with clinical trials requirements. Two hundred fifty- six adolescents (150 females, 106 males) between the ages of 13 and 21 years were enrolled at 43 different clinical trials sites throughout the United States. The majority of patients (50%) were enrolled at sites that had specific programs for adolescents. Most of the young women (85%) had acquired their infection via heterosexual transmission, whereas the largest transmission categories in men were blood or factor transfusions (43%) or same-sex contact (34%). Admission CD4 counts were lower in males (mean = 396 cells/mm³) than in females (mean = 513 cells/mm³) (p = 0.01). Psychosocial profiles revealed a variety of ongoing risk behaviors in HIV-infected adolescents. Two years into the study, 223 patients are still being observed. We conclude that adolescents can be enrolled in an observational protocol. The success of this trial will be determined by how many ACTG Protocol 220 participants are ultimately enrolled in therapeutic trials.