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PEDIATRICS Vol. 103 No. 4 April 1999, p. e47

ELECTRONIC ARTICLE:
A Phase I Study of Abacavir (1592U89) Alone and in Combination With Other Antiretroviral Agents in Infants and Children With Human Immunodeficiency Virus Infection

Received Sep 18, 1998; accepted Nov 6, 1998.

Mark W. Kline*, Suzette BlanchardDagger , Courtney V. Fletcher§, Jerry L. Shenepparallel , Ross E. McKinney Jr, Richard C. Brundage§, Mary Culnane#, Russell B. Van Dyke**, Wayne M. DanknerDagger Dagger , Andrea Kovacs, James A. McDowell, Seth Hetherington, and for the AIDS Clinical Trials Group 330 Team

From the * Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas; Dagger  Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts; § College of Pharmacy, University of Minnesota, Minneapolis, Minnesota; parallel  Department of Infectious Disease, St. Jude Children's Research Hospital, Memphis, Tennessee;  Department of Pediatrics, Duke University Medical Center, Durham, North Carolina; # Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland; ** Department of Pediatrics, Tulane University Medical School, New Orleans, Louisiana; Dagger Dagger  Department of Pediatrics, University of California School of Medicine, San Diego, California; *** Department of Pediatrics, University of Southern California, Los Angeles, California; and Glaxo-Wellcome, Inc, Research Triangle Park, North Carolina.

Objectives.  To evaluate the pharmacokinetic features, safety, and tolerance of abacavir, given alone and in combination with other nucleoside antiretroviral agents, in symptomatic human immunodeficiency virus (HIV)-infected children.

Methods.  HIV-infected children discontinued prior antiretroviral therapy and were given abacavir orally, 4 mg/kg every 12 hours for 6 weeks, followed by 8 mg/kg every 12 hours for 6 weeks (n = 39); or 8 mg/kg every 12 hours for 12 weeks (n = 8). Children then were randomized to receive a second nucleoside antiretroviral agent (zidovudine, stavudine, didanosine, or lamivudine), plus abacavir. Pharmacokinetics, safety, tolerance, CD4+ lymphocyte counts, and plasma HIV RNA concentrations were evaluated.

Results.  At a dose of 8 mg/kg every 12 hours, area under the plasma concentration-versus-time curves and plasma half-life values were comparable with those reported for adults receiving abacavir at a dose of 300 mg twice daily. One case each of hypersensitivity reaction and peripheral neuropathy occurred during abacavir monotherapy. Three children experienced neutropenia while receiving abacavir in combination with another antiretroviral agent. Mean CD4+ lymphocyte count and plasma HIV RNA concentration did not change when prior antiretroviral therapy was changed to abacavir monotherapy.

Conclusions.  Abacavir therapy is associated with good short-term tolerance and safety in HIV-infected children. Phase III studies are in progress to assess the antiviral activity of abacavir in children and adults.  Key words:  Abacavir, HIV infection, infant, child.




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