A pilot study of sequential therapy with zidovudine plus acyclovir, dideoxyinosine, and dideoxycytidine in patients with severe human immunodeficiency virus infection

J Infect Dis. 1993 Oct;168(4):810-7. doi: 10.1093/infdis/168.4.810.

Abstract

A pilot study was initiated to explore a sequential combination antiretroviral regimen in 21 patients with AIDS or advanced human immunodeficiency virus (HIV) infection, who had received little or no prior anti-HIV therapy. The mean entry CD4 cell count was 184/mm3. Patients received 3-week cycles consisting of zidovudine plus acyclovir, dideoxyinosine, and dideoxycytidine for 1 week each. Overall, the regimen was well tolerated for up to 3 years. The principal toxicities were anemia, nausea, and vomiting; 1 patient developed retinal lesions. The mean CD4 cell count reached a peak of 64 cells/mm3 above baseline at week 8 (P = .005 compared to baseline) and remained above baseline for > 40 weeks. Patients also gained weight and had decreases in serum HIV p24 antigen. Eight patients developed opportunistic infections or tumors. Only 4 patients died during 3 years of follow-up. This regimen appears to be generally tolerable and to have anti-HIV activity. Additional studies will be needed, however, to learn how to best combine the available agents in patients with HIV infection.

MeSH terms

  • AIDS-Related Complex / blood
  • AIDS-Related Complex / drug therapy*
  • AIDS-Related Complex / immunology
  • Acquired Immunodeficiency Syndrome / blood
  • Acquired Immunodeficiency Syndrome / drug therapy*
  • Acquired Immunodeficiency Syndrome / immunology
  • Acyclovir / administration & dosage
  • Acyclovir / therapeutic use*
  • Adult
  • Antigens, CD / blood
  • Biomarkers / blood
  • Body Weight
  • CD4 Antigens / blood
  • Didanosine / administration & dosage
  • Didanosine / therapeutic use*
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • HIV Core Protein p24 / blood
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • T-Lymphocyte Subsets / immunology
  • Time Factors
  • Zalcitabine / administration & dosage
  • Zalcitabine / therapeutic use*
  • Zidovudine / administration & dosage
  • Zidovudine / therapeutic use*

Substances

  • Antigens, CD
  • Biomarkers
  • CD4 Antigens
  • HIV Core Protein p24
  • Zidovudine
  • Zalcitabine
  • Didanosine
  • Acyclovir