title: Alternating treatment with didanosine and zidovudine versus either drug alone for the treatment of advanced HIV infection. The Alter Study. Nordic HIV Therapy Group.
abstract: The efficacy and safety of an alternating regime with zidovudine and didanosine versus treatment with either drug alone were investigated in a randomized, open, controlled trial, 552 patients with advanced HIV infection, 47% of whom had received prior treatment with zidovudine, were enrolled. The patients were randomly assigned to zidovudine 600 mg/day, didanosine 400 mg/day or 4-week alternations with the 2 drugs in the same dose. The study had a median length of follow-up of 88 weeks. In the overall analyses, time to death (p = 0.48) and time to death or new AIDA event (0.80) were equally distributed between the 3 treatment groups. In the subgroup of patients with a CD4 count < 100 x 10(6)/l the survival was longer in the alternating arm (p < 0.005) primarily because of differences among zidovudine naive patients. The alternating regime was better tolerated than the 2 monotherapies, with a longer time to dose reduction or withdrawal owing to side effects (p < 0.001).
authors.affiliation: Department of Infectious Diseases, RHIMA, Rigshospitalet, University of Copenhagen, Denmark.
authors.forename: J
authors.initials: J
authors.lastname: Gerstoft
authors.forename: H
authors.initials: H
authors.lastname: Melander
authors.forename: J N
authors.initials: JN
authors.lastname: Bruun
authors.forename: C
authors.initials: C
authors.lastname: Pedersen
authors.forename: P C
authors.initials: PC
authors.lastname: Głtzsche
authors.forename: O
authors.initials: O
authors.lastname: Berglund
authors.forename: L
authors.initials: L
authors.lastname: Mathiesen
authors.forename: P
authors.initials: P
authors.lastname: Skinhłj
authors.forename: S R
authors.initials: SR
authors.lastname: Norrby
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count / Q000187:drug effects; D016049:Didanosine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015215:Zidovudine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D015215:Zidovudine; D016049:Didanosine