Circulating p24 antigen levels and responses to dideoxycytidine in human immunodeficiency virus (HIV) infections. A phase I and II study

T. C. Merigan, G. Skowron, S. A. Bozzette, D. Richman, R. Uttamchandani, Margaret A Fischl, R. Schooley, M. Hirsch, W. Soo, C. Pettinelli, H. Schaumburg

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Abstract

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 atients 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.

Original languageEnglish
Pages (from-to)189-194
Number of pages6
JournalAnnals of Internal Medicine
Volume110
Issue number3
StatePublished - Jan 1 1989
Externally publishedYes

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Zalcitabine
Virus Diseases
HIV
Antigens
Acquired Immunodeficiency Syndrome
Peripheral Nervous System Diseases
Aphthous Stomatitis
Exanthema
Fever
Serum
Zidovudine
Poisons
HIV-1
Outpatients
Referral and Consultation
Body Weight
Clinical Trials
Lymphocytes
Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Merigan, T. C., Skowron, G., Bozzette, S. A., Richman, D., Uttamchandani, R., Fischl, M. A., ... Schaumburg, H. (1989). Circulating p24 antigen levels and responses to dideoxycytidine in human immunodeficiency virus (HIV) infections. A phase I and II study. Annals of Internal Medicine, 110(3), 189-194.

Circulating p24 antigen levels and responses to dideoxycytidine in human immunodeficiency virus (HIV) infections. A phase I and II study. / Merigan, T. C.; Skowron, G.; Bozzette, S. A.; Richman, D.; Uttamchandani, R.; Fischl, Margaret A; Schooley, R.; Hirsch, M.; Soo, W.; Pettinelli, C.; Schaumburg, H.

In: Annals of Internal Medicine, Vol. 110, No. 3, 01.01.1989, p. 189-194.

Research output: Contribution to journalArticle

Merigan, TC, Skowron, G, Bozzette, SA, Richman, D, Uttamchandani, R, Fischl, MA, Schooley, R, Hirsch, M, Soo, W, Pettinelli, C & Schaumburg, H 1989, 'Circulating p24 antigen levels and responses to dideoxycytidine in human immunodeficiency virus (HIV) infections. A phase I and II study', Annals of Internal Medicine, vol. 110, no. 3, pp. 189-194.
Merigan, T. C. ; Skowron, G. ; Bozzette, S. A. ; Richman, D. ; Uttamchandani, R. ; Fischl, Margaret A ; Schooley, R. ; Hirsch, M. ; Soo, W. ; Pettinelli, C. ; Schaumburg, H. / Circulating p24 antigen levels and responses to dideoxycytidine in human immunodeficiency virus (HIV) infections. A phase I and II study. In: Annals of Internal Medicine. 1989 ; Vol. 110, No. 3. pp. 189-194.
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