Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
Results of pediatric study present new questions. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.
PI Perspect. 1995 May;(no 16):10. Unique Identifier : AIDSLINE AIDS/95700460 Parks VE
Abstract:
The Data Safety and Monitoring Board recommended that the AZT alone arm be dropped in a trial (ACTG 152) of HIV-infected children comparing AZT alone, AZT plus ddI, and ddI alone. Children receiving AZT alone were experiencing higher rates of disease progression and drug-associated toxicity. Other studies involving children and AZT alone are being modified as a result. It is likely that the ACTG 152 preliminary results will also cause a change in the pediatric standard-of-care involving AZT monotherapy. Physicians are encouraged to call the National Pediatric HIV Resource Center Physician's hotline at 1-800-362-0071 for guidance in treatment decision-making. Study ACTG 076 has shown that HIV-positive women who took AZT alone significantly reduced the rate of HIV transmission to their child. The loss of an AZT-alone arm in antiretroviral combination therapy studies will not answer the question of which regimen (AZT/ddI or ddI alone) being tested is less toxic. Women interested in ACTG 076 are encouraged to call the Project Inform Hotline at 1-800-822-7411 and ask for the Women and AIDS Fact Sheet and PI Perspective, No. 14. A final issue involves problems in accurately dividing adult ddI doses into appropriate doses for children; use of a different dosage form is suggested to solve this problem.
Keywords: Adolescence Child Child, Preschool Clinical Trials, Phase II Clinical Trials, Phase III Didanosine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Drug Therapy, Combination Female Human HIV Infections/COMPLICATIONS/*DRUG THERAPY Infant Pregnancy Pregnancy Complications, Infectious Quality of Health Care Zidovudine/ADMINISTRATION & DOSAGE NEWSLETTER ARTICLE 951230
M95C3174
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Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
