We are requesting funds to establish the Tulane/LSU Pediatric AIDS Clinical Trials Unit in New Orleans. Louisiana currently ranks ninth among states in the number of new cases of AIDS in children under 13 years of age. We are currently identifying - 50 HIV- infected pregnant women per year at Charity Hospital alone; the seroprevalence among this group is 0.9%. The Pediatrics Component of the Tulane/LSU AIDS Clinic Trial Unit was established in October of 1990. Since the Component opened to accrual in January of 1991, we have successfully enrolled five children in three different pediatric ACTG protocols. In addition, we were chosen as a pilot site for ACTG #076, a study of the perinatal transmission of HIV, and have enrolled five HIV-infected pregnant women and their unborn infants in this important study. We have demonstrated our ability to recruit children of drug abuser and women and children of color into clinical trials. Specifically, we propose to recruit and enroll a minimum of forty children and newborn infants in pediatric ACTG studies each year. A particular strength of our program is our ability to recruit HIV-infected pregnant women. Therefore, we propose to enroll a minimum of 18 pregnant women per year in studies of the prevention of the perinatal transmission of HIV. A further strength is our ability to perform Phase I pharmacokinetic studies in the Tulane/LSU General Clinical Research Center. Finally, we have unique expertise in the area of subject compliance, particularly as it relates to underserved and disadvantaged populations, and propose to study this important issue among women enrolled in protocol #076. We have established linkages with many public and private agencies serving minority populations and persons at risk for HIV in the New Orleans community. We will develop an outreach program for adolescents and establish the HEART center, where women at risk for HIV can meet other such women and receive emotional and social service support, educational programs, and information on available treatment options, including ACTG clinical trials. We will continue to be active in the process of concept sheet and protocol development; currently our concept sheet # 341, """"""""Phase I Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim/Sulfamethoxazole"""""""", is being developed into an ACTG protocol.
| Watts, D Heather; Park, Jeong-Gun; Cohn, Susan E et al. (2008) Safety and tolerability of depot medroxyprogesterone acetate among HIV-infected women on antiretroviral therapy: ACTG A5093. Contraception 77:84-90 |
| 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 |
