Future as well as ongoing activities of the Tulane/LSU Pediatric AIDS Clinical Trials Unit (ACTU) will contribute to and support the scientific agenda of the Pediatric ACTG, as outlined in the CORC proposal of Dr. Stephen Spector. The Pediatric ACTU-a collaborative effort of the Tulane and Louisiana State University Schools of Medicine-has served over 250 HIV infected and affected women, infants, and children in Louisiana and the Gulf Coast region since 1991, and proposes to continue to participate in both pediatric and perinatal transmission clinical trials. In support of objective one of the Pediatric ACTG CORC proposal (to reduce the perinatal transmission rate), the unit intends to enroll at least 14 HIV-infected women in perinatal transmission trials each year. The unique centralization of prenatal care within the region will facilitate the unit's ability to recruit and retain HIV-infected pregnant women and their children on Pediatric ACTG clinical trials. In support of objectives two and three of the CORC proposal (to improve survival of HIV-infected children and to develop new agents), the unit will enroll 35 children and adolescents onto pediatric protocols, including Phase I/Il trials, Phase III efficacy trials, and Opportunistic Infection trials. The collaborative relationship between the Pediatric ACTU, HIV Outpatient Program of the Medical Center of Louisiana, Ryan White Title IV and HRSA-funded Pediatric AIDS Program, and a variety of regional community-based organizations, will ensure continued access to newly diagnosed HIV-infected pediatric patients, allowing enrollment of at least ten new (not previously enrolled) HIV-infected children onto Pediatric ACTG trials each year. Active outreach programs for high- risk adolescents and women, as well as a dynamic and representative Community Advisory Board, will enable the unit to target the needs of its constituent population; such programs allow the Pediatric ACTU to function as an integral part of the region's health care while simultaneously carrying out the scientific objectives of the Pediatric ACTG. In addition to contributing to the Pediatric ACTG through local clinical trials implementation, the Tulane/LSU Pediatric ACTU will contribute substantially to the national effort-members holding key leadership positions within the Pediatric ACTG Committee structure will help further the agenda of the Pediatric ACTG through concept sheet and protocol development and programmatic leadership positions. The unit's Behavioral Sciences component will develop and implement compliance studies to increase understanding of psychological issues facing the clinical trials patient population, and study staff will innovate new mechanisms for retaining patients on long term follow-up protocols. In this fashion, the Pediatric ACTU will endeavor to accomplish the aims of the comprehensive agenda put forth by the Pediatric ACTG within the CORC proposal. both locally and nationally.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI032913-08
Application #
2882180
Study Section
Special Emphasis Panel (ZAI1-OTP-A (01))
Program Officer
Batzold, Frederick
Project Start
1992-03-01
Project End
2001-02-28
Budget Start
1999-03-01
Budget End
2000-02-29
Support Year
8
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Tulane University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
City
New Orleans
State
LA
Country
United States
Zip Code
70118
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Jaspan, Heather B; Robinson, James E; Amedee, Angela Martin et al. (2004) Amniotic fluid has higher relative levels of lentivirus-specific antibodies than plasma and can contain neutralizing antibodies. J Clin Virol 31:190-7
Chiang, C F; Tenenbaum, S A; Verret, C R et al. (1996) Activity of granzyme A, a serine protease in the killing granules of cytotoxic T lymphocytes, is reduced in cells from HIV-infected hemophiliacs. AIDS Res Hum Retroviruses 12:235-9
Van Dyke, R B (1993) Opportunistic infections in pediatric HIV disease. Ann N Y Acad Sci 693:158-65