.ndomized Study of Didanosine Monotherapy and Combination Therapy With Zidovudine in Hemophilic and Nonhemophilic Subjects With Asymptomatic Human Immunodeficiency Virus-l Infection

To evaluate the safety and efficacy of didanosine (ddl) monotherapy and three different combinations of zidovudine (ZDV) and ddl in asymptomatic human immunodeficiency virus-l (HIV-1) infection, we conducted an open-label, phase 1/11 study in 126 asymptomatic HIV-l-infected hemophilic and nonhemophilic subjects with a CD4 count of 200 to 500/mm3 stratified for prior zidovudine treatment and baseline CD4 count. Study arms included arm A, low-dose combination (ZDV 150 mg and ddl 134 mg, daily); arm B, moderate-dose combination (ZDV 300 mg and ddl 334 mg, daily); arm C, high-dose combination (ZDV 600 mg and ddl 500 mg, daily), and arm D, ddl monotherapy (ddl 500 mg, daily). Earlier, more frequent hepatotoxicity was experienced by hemophilic subjects ( P = .008), but there were no differences in toxicity between treatment arms ( P = ,511, nor were there any differences in the rate of development of clinical endpoints by treatment (P = .41). Smaller median