2',3'-Dideoxyinosine in patients with AIDS or AIDS-related complex.
Twenty-one patients with AIDS or AIDS-related complex (ARC) received 2',3'-dideoxyinosine (didanosine; ddI) intravenously and then orally (initial dosages of 0.4 mg/kg and 0.8 mg/kg every 12 hours, respectively) for 6-44 weeks in an escalating-dose study. The major dose-limiting effects were peripheral neuropathy (three patients) and pancreatitis (two patients), which were observed at dosages greater than or equal to 20 mg/(kg.d). Hyperuricemia occurred at greater than or equal to 30 mg/(kg.d). No hematologic toxicity developed except for possible sporadic thrombocytopenia (two patients). Significant decreases in serum levels of p24 antigen and increases in CD4+ and CD8+ lymphocytes were noted at 2, 6, and 10-20 weeks and over a wide range of dosages, including the lowest given. Most patients had an increased feeling of well-being and/or a weight gain of greater than or equal to 2 kg at 6 weeks. For this population, ddI has promise as a therapeutic agent, thus warranting further study of this agent in controlled clinical trials.
Dolin
R
R
Department of Medicine, University of Rochester School of Medicine and Dentistry, New York 14642.
Lambert
J S
JS
Morse
G D
GD
Reichman
R C
RC
Plank
C S
CS
Reid
J
J
Knupp
C
C
McLaren
C
C
Pettinelli
C
C
D000386:AIDS-Related Complex / Q000188:drug therapy*; D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D000328:Adult; D015496:CD4-Positive T-Lymphocytes; D016049:Didanosine / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D015683:Gene Products, gag / Q000032:analysis; D015488:HIV Antigens / Q000032:analysis; D016655:HIV Core Protein p24; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000139:chemically induced; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D014527:Uric Acid / Q000097:blood; D014758:Viral Core Proteins / Q000032:analysis
D015683:Gene Products, gag; D015488:HIV Antigens; D016655:HIV Core Protein p24; D014758:Viral Core Proteins; D014527:Uric Acid; D016049:Didanosine