Pediatric HIV clinical trials in the United States.

: The Pediatric AIDS Clinical Trials Group (PACTG) is a national network of clinical trial sites funded by the National Institute of Child Health and Human Development and the National Institute of Allergy and Infectious Diseases (NIAID). PACTG studies, particularly ACTG 076, have been instrumental in establishing the standard of care for prevention and treatment of childhood HIV. The development of age-appropriate drugs is a fundamental challenge facing researchers in the pediatric therapeutic clinical trial arena. The differences between HIV-positive adults and children are outlined and the special developmental problems faced by HIV-infected children are described. PACTG is working to decrease the rates of HIV perinatal transmission in the U.S., achieve a 10-year survival rate for more than 90 percent of HIV-infected children, and investigate and develop early intervention strategies for infants and adolescents. To meet these goals, PACTG is conducting a number of studies: ACTG 316 examines whether nevirapine will help reduce perinatal HIV transmission, ACTG 219 will follow all children enrolled in PACTG studies until they are 18 years old, and study's ACTG 356 and ACTG 345 will examine whether early and aggressive therapy in children can alter the course of HIV disease. The Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection is available in draft format and recommends initiating combination antiretroviral therapy with potent drug regimens in all infants less than 12 months of age upon diagnosis.