[Federal Register Volume 62, Number 189 (Tuesday, September 30, 1997)]
[Notices]
[Pages 51115-51116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25773]


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HEALTH RESOURCES AND SERVICES ADMINISTRATION


Guidelines for the Use of Antiretroviral Agents in Pediatric HIV 
Infection

AGENCY: Health Resources and Services Administration, Department of 
Health and Human Services.

ACTION: Request for comments.

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SUMMARY: The Health Resources and Services Administration (HRSA) is 
requesting comments from all interested parties on the following 
document: ``Guidelines for Use of Antiretroviral Agents in Pediatric 
HIV Infection''. The document was developed by specialists in the care 
of HIV-infected infants, children and adolescents, family members of 
HIV-infected children, and governmental agency representatives at a 
meeting on July 9 and 10, 1997, convened by the National Pediatric and 
Family HIV Resource Center (NPHRC) and HRSA. While the pathogenesis of 
HIV infection and the general virologic and immunologic principles 
underlying the use of antiretroviral therapy are similar for all HIV 
infected individuals, there are therapeutic and management 
considerations that are unique to HIV infected infants, children and 
adolescents. These include acquisition of infection through perinatal 
exposure for many infected children; in utero exposure to zidovudine 
(ZDV) and other antiretroviral medications in many perinatally-infected 
children; differences in diagnostic evaluation in perinatal infection; 
differences in immunologic markers (eg. CD4+ lymphocyte count) in young 
children; changes in pharmacokinetic parameters with age due to the 
continuing development and maturation of organ systems involved in drug 
metabolism and clearance; differences in the clinical and virologic 
manifestations of perinatal HIV infection secondary to the occurrence 
of primary infection in a still-developing, immunologically naive 
individual; and special considerations related to treatment adherence 
in children and adolescents. This document addresses the pediatric-
specific issues related to antiretroviral treatment and provides 
general guidelines to physicians caring for infected children and 
adolescents.

DATES: Comments on the proposed guidelines must be received on or 
before October 30, 1997 in order to ensure that HRSA will be able to 
consider the comments in preparing the final guidelines.

ADDRESSES: Written comments to this notice should be submitted to: The 
HIV/AIDS Treatment Information Service, P.O. Box 6303, Rockville, MD 
20849-6303. Only written comments will be accepted. After consideration 
of the comments, the final document will be published in the Centers 
for Disease Control and Prevention (CDC) ``Morbidity and Mortality 
Weekly Report'' (MMWR).

FOR FURTHER INFORMATION CONTACT: Copies of the ``Guidelines for the Use 
of Antiretroviral Agents in Pediatric HIV Infection'' are available 
from the National AIDS Clearinghouse (1-800-458-5231) and on the 
Clearinghouse Web sites (http://www.cdcnac.org) and from the HIV/AIDS 
Treatment Information Service (1-800-448-0440; Fax: 301-519-6616; TTY: 
1-800-243-7012) and on their Web site (http://www.hivatis.org).

SUPPLEMENTARY INFORMATION: A Working Group on Antiretroviral Therapy 
and Medical Management of HIV-Infected Children composed of

[[Page 51116]]

specialists in the care of HIV-infected infants, children and 
adolescents, family members of HIV-infected children, and governmental 
agency representatives was convened by the National Pediatric and 
Family HIV Resource Center (NPHRC), sponsored by the Health Resources 
and Services Administration (HRSA), on July 9 and 10, 1997, to 
establish and finalize a new set of guidelines for the treatment of 
HIV-infected infants, children and adolescents. The Working Group was 
co-chaired by Dr. James Oleske, University of Medicine and Dentistry of 
New Jersey (UMDNJ)-New Jersey Medical School, Newark, NJ and Dr. 
Gwendolyn Scott, University of Miami, Miami, FL. The treatment 
recommendations provided in this document are based on published and 
unpublished data on HIV infection and treatment in adults and children 
and, when no definitive data were available, the consensus of the 
Working Group participants in the treatment of pediatric HIV infection. 
It is the intent of the Working Group that the guidelines be regarded 
as flexible and not supplant the clinical judgement of experienced 
health care providers. It is recognized that these guidelines will need 
to be modified as new information and experience become available.

    Dated: September 24, 1997.
Claude Earl Fox,
Acting Administrator.
[FR Doc. 97-25773 Filed 9-29-97; 8:45 am]
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