Thomas C. Merigan, MD; Gail Skowron, MD; Samuel A. Bozzette, MD; Douglas Richman, MD; Raj Uttamchandani, MD; Margaret Fischl, MD; Robert Schooley, MD; Martin Hirsch, MD; Whaijen Soo, MD, PhD; Carla Pettinelli, MD, PhD; Herbert Schaumburg, MD
Study Objective: To determine the safety and efficacy of dideoxycytidine in patients with the acquired immunodeficiency syndrome (AIDS) or advanced AIDS-related complex.
Design: A partially randomized phase I and II outpatient, dose-ranging study.
Setting: Four university medical centers involving government-supported referral AIDS Clinical Trial Units.
Patients: Sixty-one patients with AIDS or advanced AIDS-related complex and 100 pg/mL or more serum p24 antigen titers.
Interventions: Dideoxycytidine was administered orally at 0. 06, 0.03, 0.01, or 0.005 mg/kg body weight every 4 hours for 3 to 6 months depending on tolerance and benefit.
Measurements and Main Results: In patients receiving 0. 06 and 0.03 mg/kg, diffuse erythematous rash, fever, and aphthous stomatitis occurred in the first weeks of therapy, but resolved later. Hematopoietic suppression was rare. Peripheral sensory neuropathy occurred in patients receiving 0.06 mg/kg and 0.03 mg/kg and improved after discontinuation of therapy. Serum p24 antigen fell significantly (P < 0.01) from baseline entry values in most of these patients. The CD4 lymphocytes rose transiently at the 0.03 mg/kg dosage. At the 0.005 mg/kg dosage, skin rash, fever, and aphthous stomatitis were mild or absent. Peripheral neuropathy, which occurred in all patients receiving 0.01 mg/kg was less severe than at higher dosages. At the 0.005 mg/kg dosage, peripheral neuropathy was occasionally seen. Significant suppression of serum p24 antigen was seen in most patients with AIDS-related complex receiving 0.01 mg/kg and less frequently in patients receiving 0.005 mg/kg.
Conclusions: Less toxic regimens of dideoxycytidine merit clinical assessment for advanced anti-human immunodeficiency virus-1 (HIV) infection. Several studies alternating dideoxycytidine and zidovudine are in progress.
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Merigan TC, Skowron G, Bozzette SA, Richman D, Uttamchandani R, Fischl M, et al. Circulating p24 Antigen Levels and Responses to Dideoxycytidine in Human Immunodeficiency Virus (HIV) Infections: A Phase I and II Study. Ann Intern Med. 1989;110:189–194. doi: 10.7326/0003-4819-110-3-189
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Published: Ann Intern Med. 1989;110(3):189-194.
HIV, Infectious Disease.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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