This is the competitive renewal application of the Baylor College of Medicine-University of Texas Medical School at Houston (BCM-UT) for continuation of the pediatric AIDS Clinical Trials Unit (ACTU) funding first awarded by the National Institute of Allergy and Infectious Diseases (NIAID) in September, 1988, and expanded in October, 1990. In the short time interval of 4 years BCM-UT have identified a large population of HIV-infected women and their infants and entered substantial numbers of these patients into pediatric/obstetrical AIDS Clinical Trials Group (ACTG) protocols using the resources of several institutions at the Texas Medical Center. The clustering of these institutions and supportive personnel make up the Pediatric-Obstetrical HIV Research Center, centered principally at Texas Children's Hospital (BCM) and Hermann Hospital (UT) and aided in large part by ancillary support of the General Clinical Research Center (GCRC) units at these institutions. Participating institutions include Ben Taub General Hospital (BTGH), Lyndon Baines Johnson Hospital (LBJH), M.D. Anderson Hospital, and the University of Houston School of Pharmacy. Through a series of interrelated National Institutes of Health (NIH) grants and contracts and private resources, the target HIV-infected pregnant woman and infant population in Houston has been offered state-of-the-art clinical research trials. Over 140 of these minority, often drug-addicted, inner city patients have been enrolled in BCM-UT ACTG protocols dealing with antiretroviral agents, prophylactic therapies, and immunomodulators. By reapplication for pediatric ACTG funding, BCM-UT declare their intent to continue to expand the scope of HIV-related clinical research in an attempt to interrupt perinatal transmission of the infection; develop effective HIV vaccines for children, including prenatal vaccines; examine new antiretroviral agents and novel approaches to their administration; and participate in drug trials for opportunistic infections that plague HIV-infected patients. Specifically, for each of 4 consecutive years the BCM-UT ACTU will recruit at least 50 HIV-infected pregnant women and their infants into pediatric-obstetrical ACTG protocols in an attempt to accomplish the specific aims. We prepare to do this by application of Part A (ACTU operations) and Part B (Virology Laboratory, Immunology Laboratory, Pharmacology Laboratory) of RFA 92- AI-10. We are confident that, given suitable support, BCM-UT will continue to be at the forefront of pediatric-obstetrical HIV protocol development and patient enrollment and that we will be able to fulfill our commitment to the HIV-afflicted pregnant women and infants in the United States.
| Chinen, Javier; Notarangelo, Luigi D; Shearer, William T (2016) Advances in clinical immunology in 2015. J Allergy Clin Immunol 138:1531-1540 |
| Mandala, Wilson L; Ananworanich, Jintanat; Apornpong, Tanakorn et al. (2014) Control lymphocyte subsets: can one country's values serve for another's? J Allergy Clin Immunol 134:759-761.e8 |
| Chinen, Javier; Shearer, William T (2010) Secondary immunodeficiencies, including HIV infection. J Allergy Clin Immunol 125:S195-203 |
| Aldrovandi, Grace M; Chu, Clara; Shearer, William T et al. (2009) Antiretroviral exposure and lymphocyte mtDNA content among uninfected infants of HIV-1-infected women. Pediatrics 124:e1189-97 |
| Chinen, Javier; Shearer, William T (2008) Advances in basic and clinical immunology in 2007. J Allergy Clin Immunol 122:36-41 |
| Chinen, Javier; Shearer, William T (2008) 6. Secondary immunodeficiencies, including HIV infection. J Allergy Clin Immunol 121:S388-92;quiz S417 |
| Davis, Carla M; Shearer, William T (2008) Diagnosis and management of HIV drug hypersensitivity. J Allergy Clin Immunol 121:826-832.e5 |
| Shearer, William T (2008) Breastfeeding and HIV infection. Pediatrics 121:1046-7 |
| Foster, Samuel B; McIntosh, Kenneth; Thompson, Bruce et al. (2008) Increased incidence of asthma in HIV-infected children treated with highly active antiretroviral therapy in the National Institutes of Health Women and Infants Transmission Study. J Allergy Clin Immunol 122:159-65 |
| Fletcher, Courtney V; DeVille, Jaime G; Samson, Pearl M et al. (2007) Nonlinear pharmacokinetics of high-dose recombinant fusion protein CD4-IgG2 (PRO 542) observed in HIV-1-infected children. J Allergy Clin Immunol 119:747-50 |
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