Antiretroviral Therapy and Medical Management of Pediatric HIV Infection

These guidelines were developed by the Working Group on Antiretroviral Therapy and Medical Management of Infants, Children and Adolescents with HIV Infection convened by the National Pediatric and Family HIV Resource Center (NPHRC), the Health Resources and Services Administration (HRSA), and the National Institutes of Health (NIH). The Co-Chairs of the Working Group were James Oleske, MD, MPH, University of Medicine and Dentistry of New Jersey (UMDNJ)-New Jersey Medical School, Newark, NJ and Gwendolyn B. Scott, MD, University of Miami School of Medicine, Miami, FL.Members of the Working Group who participated in the development of this document include: Elaine Abrams (Harlem Hospital Center, New York City, NY), Arthur Ammann (AmFAR, New York City, NY), Martin Anderson (University of California at Los Angeles, Los Angeles, CA), Carol Baker (Baylor College of Medicine, Houston, TX), Lawrence Bernstein (Albert Einstein College of Medicine, Bronx, NY), Michael Brady (Columbus Children's Hospital, Columbus, OH), Kathleen Brooke (Family Representative), Sandra Burchett (Children's Hospital, Boston, MA), Carolyn Burr (NPHRC, Newark, NJ), Joseph Cervia (Cornell Medical Center, New York City, NY), Diana Clarke (Boston Medical Center, Boston, MA), Daniel Collado (Family Representative), Ellen Cooper (Boston University School of Medicine, Boston, MA), Marilyn Crain (University of Alabama at Birmingham, Birmingham, AL), Barry Dashefsky (NPHRC and UMDNJ-New Jersey Medical School, Newark, NJ), Carol DiPaolo (Family Representative), Diane Donovan (Family Representative), Janet A. Englund (Baylor College of Medicine, Houston, TX), Mary Glenn Fowler (NIH, Rockville, MD), Lisa M Frenkel (University of Washington, Seattle, WA), Donna Futterman (Montefiore Medical Center, New York City, NY), Anne Gershon (Columbia University, New York City, NY), Samuel Grubman (St Vincent's Hospital and Medical Center of New York, New York City, NY), Peter Havens (Children's Hospital of Wisconsin, Milwaukee, WI), Karen Hench (HRSA, Rockville, MD), Neal Hoffman (Montefiore Medical Center, Bronx, NY), Walter Hughes (St Jude Children's Research Hospital, Memphis, TN), George Johnson (Medical University of South Carolina, Charleston, SC), Rosemary Johnson (Family Representative), Michael Kaiser (HRSA, Rockville, MD), Aaron Kaplan (Tulane Medical School, New Orleans, LA), Mark Kline (Baylor College of Medicine, Houston, TX), Andrea Kovacs (LAC + USC Medical Center, Los Angeles, CA), Keith Krasinski (New York University Medical Center, New York, NY), Kathleen McGann (Washington University Medical Center, St Louis, MO), Kenneth McIntosh (Children's Hospital, Boston, MA), Ross McKinney (Duke University Medical Center, Durham, NC), George McSherry (UMDNJ-New Jersey Medical School, Newark, NJ), Mark Mintz (Children's Hospital of Philadelphia, Philadelphia, PA), Charles Mitchell (University of Miami, Miami, FL), Lynne M Mofenson (NIH, Rockville, MD), John Moye, Jr (NIH, Rockville, MD), Brigitta Mueller (Children's Hospital, Boston, MA), Sharon Murphy (Children's Memorial Hospital, Chicago, IL), Sharon Nachman (State University of New York Health Science Center at Stony Brook, Stony Brook, NY), Mary Jo O'Hara (NPHRC, Newark, NJ), James Oleske (UMDNJ-New Jersey Medical School, Newark, NJ), Savita Pahwa (North Shore University Hospital, Manhasset, NY), Paul Palumbo (UMDNJ-New Jersey Medical School, Newark, NJ), Ligia Peralta (University of Maryland, Baltimore, MD), Jane Pitt (Columbia University Medical Center, New York City, NY), Philip Pizzo (Harvard Medical School/Children's Hospital, Boston, MA), Tamara Rakusan (Children's Hospital, Washington, DC), Merlin Robb (Walter Reed Army Institute of Research, Rockville, MD), John Rodman (St Jude Children's Research Hospital, Memphis, TN), Arye Rubinstein (Albert Einstein College of Medicine, Bronx, NY), Mary Sawyer (Emory University, Atlanta, GA), Gwendolyn B. Scott (University of Miami, Miami, FL), John Sever (Children's National Medical Center, Washington, DC), Minora Sharpe (Family Representative), William Shearer (Baylor College of Medicine, Houston, TX), R. J. Simonds (Centers for Disease Control and Prevention, Atlanta, GA), Peter Smith (Hasbro Children's Hospital, Providence, RI), Stephen Spector (University of California at San Diego, La Jolla, CA), Deborah Storm (UMDNJ-New Jersey Medical School, Newark, NJ), Russell Van Dyke (Tulane University School of Medicine, New Orleans, LA), Diane Wara (University of California at San Francisco School of Medicine, San Francisco, CA), Catherine Wilfert (Duke University Medical Center, Durham, NC; The Pediatric AIDS Foundation, Santa Monica, CA), Harland Winter (Boston Medical Center, Boston, MA), Andrew Wiznia (Bronx Lebanon Hospital Center, Bronx, NY), Ram Yogev (Children's Memorial Hospital, Chicago, IL).In 1993, the Working Group on Antiretroviral Therapy and Medical Management of HIV-infected Children, composed of specialists in the care of infants, children, and adolescents with HIV infection, was convened by the National Pediatric and Family HIV Resource Center (NPHRC). On the basis of available data and a consensus reflecting clinical experience, the Working Group concluded that antiretroviral therapy was indicated for any child with a definitive diagnosis of HIV infection who had evidence of substantial immunodeficiency (based on age-related CD4+ T-lymphocyte count thresholds) and/or who had HIV-associated symptoms. Zidovudine (ZDV) monotherapy was recommended as the standard of care for initiation of therapy. Routine antiretroviral therapy for infected children who were asymptomatic or had only minimal symptoms (eg, isolated lymphadenopathy or hepatomegaly) and normal immune status was not recommended.1Since the Working Group developed these recommendations, dramatic advances have been made in laboratory and clinical research. The rapidity and magnitude of HIV replication during all stages of infection are greater than believed previously and account for the emergence of drug-resistant viral variants when antiretroviral treatment does not maximally suppress replication.2,3 New assays that quantitate plasma HIV RNA copy number have become available, permitting a sensitive assessment of risk for disease progression and adequacy of antiretroviral therapy. A new class of antiretroviral drug, protease inhibitor (PI) agents, has become available; these agents have reduced HIV viral load to levels that are undetectable with currently available assays and have reduced disease progression and mortality in many patients with HIV on of antiretroviral of maximally viral replication to the development of and to the of Pediatric AIDS Group have that the risk for HIV with the of a of during and and to the advances in HIV have to in the treatment and of HIV infection in the A of the therapy of patients with HIV infection has been by the National Institutes of Health to of Therapy of HIV Infection for infected and adolescents have been developed by the of Health and Services of for of HIV the of HIV infection and the and the of antiretroviral therapy are for all HIV-infected HIV-infected infants, children, and adolescents HIV infection children and during or the of the of treatment in infected during the of HIV HIV infection during the development of the immune the clinical of HIV infection and the of and of infection for of infected children in the of to and antiretroviral during and the for treatment or to or during the the to of and in and to therapy in children and adolescents the antiretroviral treatment guidelines for children and to guidelines for antiretroviral treatment to for HIV-infected the Health and Resources Administration (HRSA), and the Working Group on Antiretroviral Therapy and Medical Management of HIV-infected Children, of specialists in the care of HIV-infected children and of HIV-infected children, and The Working Group in and in to and new guidelines for the treatment of HIV-infected infants, children, and to antiretroviral the Working Group the to HIV and the of HIV treatment in this are on and data the treatment of HIV infection in and children when definitive data were available, the clinical of the Working Group The Working Group for the guidelines to and to not the clinical of care The of this on and 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antiretroviral treatment These the treatment of with HIV infection to as as the of with HIV infection or during HIV and HIV with are recommended as standard of care for all in the by the the of and the College of and and are by the Working of with HIV infection for the of and for care of and of HIV infection during the HIV-infected to antiretroviral therapy and infection for of antiretroviral with during and and to to the risk for HIV to of infected the for HIV and in the and to are initiation of in all at to in with and of to initiation of antiretroviral are not for HIV during and HIV recommended during the in was not during the or for HIV and of the The status of the of the recommended as as and at to in all to HIV-infected who have been are in the of the or who have at risk for to and to HIV of infection in infected by and in all infected by viral A of HIV by or RNA HIV infection and by a on a as as the of the become the of at to and at to at for of by or in with a in HIV infection 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