title: A randomized study of the safety and antiretroviral activity of hydroxyurea combined with didanosine in persons infected with human immunodeficiency virus type 1. American Foundation for AIDS Research Community-Based Clinical Trials Network.
abstract: This randomized open-label trial of human immunodeficiency virus type 1-infected persons compared safety and efficacy for 38 patients receiving hydroxyurea/didanosine combination therapy with findings in 42 persons given didanosine monotherapy for 12 weeks, followed by 12 weeks of hydroxyurea/didanosine combination therapy for all patients. Week 12 on-treatment group comparisons showed a mean decrease in virus load between hydroxyurea/didanosine versus didanosine groups of -0.93 versus -0.74 log10 copies/mL (P=.20); a higher percentage of the hydroxyurea/didanosine group below the assay's detection limit (500 copies/mL), 29% versus 7% (P=.017); and median change in CD4 cells for the hydroxyurea/didanosine versus didanosine group of 0 versus 43 cells/mm3 (P=.045), although median change in CD4 percentage was similar (0.9% vs. 1.2%, P=.64). Week 24 virus load reductions and CD4 cell changes were similar in both groups. Intent-to-treat and on-treatment analyses showed similar results. The hydroxyurea/didanosine combination was well tolerated.
authors.affiliation: Community Research Initiative of New England, Brookline, Massachusetts, USA.
authors.forename: J A
authors.initials: JA
authors.lastname: Hellinger
authors.forename: M K
authors.initials: MK
authors.lastname: Iwane
authors.forename: J J
authors.initials: JJ
authors.lastname: Smith
authors.forename: A N
authors.initials: AN
authors.lastname: Fleishman
authors.forename: R A
authors.initials: RA
authors.lastname: Torres
authors.forename: S
authors.initials: S
authors.lastname: Schrader
authors.forename: G
authors.initials: G
authors.lastname: Perez
authors.forename: C J
authors.initials: CJ
authors.lastname: Cohen
authors.forename: G
authors.initials: G
authors.lastname: Skowron
authors.forename: M F
authors.initials: MF
authors.lastname: Giordano
authors.forename: G
authors.initials: G
authors.lastname: Accetta
authors.forename: E C
authors.initials: EC
authors.lastname: Cooper
authors.forename: K R
authors.initials: KR
authors.lastname: Frost
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D004279:DNA, Viral / Q000097:blood; D016049:Didanosine / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects* / Q000502:physiology; D006801:Humans; D006918:Hydroxyurea / Q000627:therapeutic use*; D008297:Male; D019384:Nucleic Acid Synthesis Inhibitors / Q000627:therapeutic use; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D004279:DNA, Viral; D019384:Nucleic Acid Synthesis Inhibitors; D018894:Reverse Transcriptase Inhibitors; D016049:Didanosine; D006918:Hydroxyurea