Abstract | STUDY OBJECTIVE: 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: 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 less than 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:
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Authors | T C Merigan, G Skowron, S A Bozzette, D Richman, R Uttamchandani, M Fischl, R Schooley, M Hirsch, W Soo, C Pettinelli |
Journal | Annals of internal medicine
(Ann Intern Med)
Vol. 110
Issue 3
Pg. 189-94
(Feb 01 1989)
ISSN: 0003-4819 [Print] United States |
PMID | 2536257
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Dideoxynucleosides
- HIV Antigens
- HIV Core Protein p24
- Retroviridae Proteins
- Zalcitabine
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Topics |
- AIDS-Related Complex
(drug therapy, immunology)
- Acquired Immunodeficiency Syndrome
(drug therapy, immunology)
- Administration, Oral
- Dideoxynucleosides
(administration & dosage, therapeutic use, toxicity)
- Drug Evaluation
- Female
- HIV Antigens
(analysis)
- HIV Core Protein p24
- Humans
- Male
- Random Allocation
- Retroviridae Proteins
(analysis)
- Zalcitabine
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