The National Institute of Allergy and Infectious Diseases(NIAID) has awarded 23 four-year grants to continue the work ofthe Pediatric AIDS Clinical Trials Group (ACTG). A nationwideclinical trials network, the group evaluates improved strategiesto prevent infants of infected mothers from acquiring HIV inutero or during birth, and for treating children and adolescentsalready infected with the virus. First-year funding for the newawards totals $32 million.
The money will support 21 AIDS Clinical Trials Units (ACTUs,listed below), a Statistical and Data Management Center, and anew Pediatric ACTG Coordinating and Operations Center. The latterwill provide scientific and managerial leadership and performcentralized, advanced laboratory studies.
Through June 1996, 9,870 cases of AIDS in children andadolescents as old as 19 years had been reported to the U.S.Centers for Disease Control and Prevention (CDC). Of the 7,296cases in children under age 13, nine out of 10 patients acquiredHIV perinatally from their infected mothers. These data reinforcethe need to develop better strategies to prevent and treatmother-to-infant HIV transmission.
"The Pediatric ACTG brings together a superbly qualifiedgroup of investigators focused on the special problems ofpreventing and treating AIDS and associated opportunisticinfections in infants, children and adolescents," commentsNIAID Director Anthony S. Fauci, M.D. "We are confident thatthe Pediatric ACTG will continue to make significantcontributions to improving the lives of all young people infectedwith HIV."
Stephen A. Spector, M.D., principal investigator of theUniversity of California at San Diego ACTU, will be Group Leaderof the Pediatric ACTG. As such, he will direct its Coordinatingand Operations Center, which will be managed by Social andScientific Systems in Bethesda, Md.
"The restructured Pediatric ACTG will greatly enhance ourability to conduct trials that address questions of high publichealth and scientific priority," says Dr. Spector. One grouppriority is to incorporate pathogenesis-based research intoclinical trials. These studies will enable the ACTU investigatorsto better define the course of disease in children and to analyzehow HIV infection and its treatments affect the developing immunesystem. The Pediatric ACTG is uniquely suited to carry out suchstudies because they require integrating clinical and laboratoryresearch.
The Statistical and Data Management Center will be headed byRichard Gelber, Ph.D., of the Harvard School of Public Health.
The 21 clinical trials sites include 20 of the 22 currentNIAID- sponsored Pediatric ACTUs and one new site in Alabama. Thefunding level for the Pediatric ACTG is consistent with therecommendations of the Report of the NIH AIDS Research ProgramEvaluation Working Group, chaired by Princeton virologist ArnoldLevine, Ph.D. This report--an external review of the NIH AIDSprogram issued by the NIH Office of AIDS Research in1996--recommended a decreased level of funding for the PediatricACTG given the changing epidemiology of HIV infection in childrenin the United States.
In addition to the NIAID-sponsored components of the PediatricACTG, the National Institute of Child Health and HumanDevelopment (NICHD) currently funds 33 smaller clinical trialssites. The NICHD investigators participate in group committeesand protocol development teams, enroll patients and share thesame scientific group leadership as NIAID. Together, these 54clinical sites provide the structure and resources for addressingthe Pediatric ACTG's goals.
Moreover, through the Ryan White Service Program, the U.S.Public Health Service enhances pediatric AIDS clinical researchby providing resources such as day care and travel money tofacilitate the participation of HIV-infected women and childrenin NIH-sponsored clinical research. Health care providersreceiving funds from this program are located near 20 of the 21NIAID clinical sites and can easily make patient referrals to thegroup's trials.
As of February 1997, the Pediatric ACTG had initiated 60trials, and 27 studies are now recruiting patients. Cumulativeenrollment since 1987 totals 10,867 children, adolescents andpregnant women. Among its most significant contributions, thegroup has: 1) demonstrated that antiretroviral therapy given toHIV-infected pregnant women and their newborns can reduce therisk of perinatal transmission by two thirds; 2) showed that IVIGcan effectively prevent serious bacterial infections in childrenwith HIV; 3) demonstrated that ddI or ddI plus AZT are superiorto AZT monotherapy for children with symptomatic HIV infection orAIDS; and 4) developed guidelines for preventing Pneumocystiscarinii pneumonia in HIV-infected children.
The original NIAID ACTG established in 1987 included two sitesthat enrolled children with AIDS. Additional pediatric sites wereadded in 1988 and 1989, and again in 1992. Followingrecommendations of an independent advisory panel, the Adult andPediatric ACTGs will now operate separately. Currently there are30 adult clinical sites.
For information on Pediatric ACTG trials currently open toenrollment, call the AIDS Clinical Trials Information Service at1-800-TRIALS-A (1-800-874-2572), Monday through Friday, 9:00 a.m.to 7:00 p.m. Eastern time. Bilingual health specialists areavailable to talk to Spanish-speaking callers.
NIAID and NICHD are components of the National Institutes ofHealth (NIH). NIAID conducts and supports research aimed atpreventing, diagnosing and treating illnesses such as AIDS andother sexually transmitted diseases, tuberculosis, asthma andallergies. NIH is an agency of the U.S. Department of Health andHuman Services. ### Press releases, fact sheets and othermaterials from NIAID are available on the Internet via the NIAIDhome page at http://www.niaid.nih.gov.
NIAID PEDIATRIC AIDS CLINICAL TRIALS UNITS AND PRINCIPALINVESTIGATORS
ALABAMA University of Alabama at Birmingham Robert Pass, M.D.
CALIFORNIA University of California at Los Angeles Yvonne J.Bryson, M.D.
University of California at San Diego Stephen A. Spector, M.D.
University of California at San Francisco Diane W. Wara, M.D.
DISTRICT OF COLUMBIA Children's National Medical Center JohnL. Sever, M.D., Ph.D.
FLORIDA University of Miami School of Medicine Gwendolyn B.Scott, M.D.
ILLINOIS Children's Memorial Hospital Ram Yogev, M.D.
LOUISIANA Tulane University School of Medicine Russell VanDyke, M.D.
MARYLAND Johns Hopkins University Andrea Ruff, M.D.
MASSACHUSETTS Children's Hospital Kenneth McIntosh, M.D.
University of Massachusetts Medical Center John L. Sullivan,M.D.
NEW JERSEY UMDNJ-New Jersey Medical School James Oleske, M.D.,M.P.H.
NEW YORK Bronx-Lebanon Hospital Center Andrew A. Wiznia, M.D.
Columbia University Anne A. Gershon, M.D.
New York University Medical Center William Borkowsky, M.D.
NORTH CAROLINA Duke University Medical Center Ross McKinney,Jr., M.D.
PENNSYLVANIA Children's Hospital of Philadelphia Stuart E.Starr, M.D.
PUERTO RICO University of Puerto Rico Clemente Diaz, M.D.
TENNESSEE St. Jude Children's Research Hospital Walter Hughes,M.D.
TEXAS Baylor College of Medicine William T. Shearer, M.D.,Ph.D. WASHINGTON Children's Hospital and Medical Center Lisa M.Frenkel, M.D.
Materials provided by National Institute of Allergy and Infectious Diseases. Note: Content may be edited for style and length.
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