Four highly experienced and successful domestic Clinical Research Sites (CRS) will form the HIV Centers for Underrepresented Populations in REsearch (HIV CURE) CTU. The CTU will be located at the University of California San Diego (UCSD) with Stephen A. Spector serving as the PI. The 4 CRSs are located at Baylor College of Medicine in Houston (William T. Shearer, Leader), Lurie Children's Hospital in Chicago (Northwestern - Ram Yogev, Leader), St. Jude Children's Research Hospital/University of Tennessee in Memphis (Patricia Flynn, Leader), and UCSD (SA Spector, Leader). These 4 CRSs have demonstrated the ability to enroll subjects into protocols involving numerous clinical trials networks including IMPAACT, ACTG, PHACS, ATN, INSIGHT, AERAS and DMID. These CRSs represent 4 of the 5 the highest accruing sites and the 4 highest CRSs in scientific contribution to the IMPAACT Network.
The Specific Aims of the HIV CURE CTU are: 1. Evaluate the pharmacokinetics, safety, and drug interactions of new and existing antiretroviral agents and formulations;2. Evaluate novel approaches for tuberculosis prevention, treatment and diagnosis;3. Develop and test biomedical/behavioral interventions to prevent HIV transmission between infected youth and their sexual partners and mother-to-child transmission (MTCT);4. Evaluate the immunogenicity, safety and efficacy of vaccines of high priority in HIV-infected women, pregnant women, infants, children and youth;5. Evaluate potential for HIV cure through therapeutic interventions aimed at prevention and clearance of HIV reservoirs;6. Evaluate the pharmacokinetics, safety, and efficacy of new drugs and drug combinations to treat hepatitis B (HBV) and hepatitis C (HCV);and 7. Determine optimal and feasible methods for the prevention and management of complications of HIV infection and its treatment. The HIV Cure CTU will use its extensive capacity to recruit subjects into the IMPAACT, ACTG and HPTN Networks HIV-infected and at-risk populations that are historically underrepresented in clinical trials including minorities and people of color with an emphasis on women, pregnant women, youth, children and newborns which will broaden the applicability of clinical trials performed within the DAIDS networks.

Public Health Relevance

This CTU application combines 4 highly experienced and successful domestic CRSs to form the HIV Centers for Underrepresented Populations in Research (HIV CURE) CTU that will focus on recruitment to studies of the IMPAACT, ACTG and HPTN Networks HIV-infected and at-risk minority subjects with an emphasis on women, pregnant women, youth, children and newborns. Thus, this application is highly relevant to this RFA.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
2UM1AI069536-08
Application #
8609636
Study Section
Special Emphasis Panel (ZAI1-UKS-A (S3))
Program Officer
Tauscher, Gail H
Project Start
2007-01-01
Project End
2020-11-30
Budget Start
2013-12-01
Budget End
2014-11-30
Support Year
8
Fiscal Year
2014
Total Cost
$2,450,975
Indirect Cost
$389,695
Name
University of California San Diego
Department
Pediatrics
Type
Schools of Medicine
DUNS #
804355790
City
La Jolla
State
CA
Country
United States
Zip Code
92093
Viani, Rolando M; Araneta, Maria R; Spector, Stephen A (2016) In-Country Migration and Risk Factors for HIV Acquisition among Pregnant Women in Tijuana, Mexico. J Int Assoc Provid AIDS Care 15:228-31
Gupta, Amita; Montepiedra, Grace; Gupte, Akshay et al. (2016) Low Vitamin-D Levels Combined with PKP3-SIGIRR-TMEM16J Host Variants Is Associated with Tuberculosis and Death in HIV-Infected and -Exposed Infants. PLoS One 11:e0148649
Singh, Kumud K; Qin, Min; Brummel, Sean S et al. (2016) Killer Cell Immunoglobulin-Like Receptor Alleles Alter HIV Disease in Children. PLoS One 11:e0151364
Brummel, Sean S; Singh, Kumud K; Maihofer, Adam X et al. (2016) Associations of Genetically Determined Continental Ancestry With CD4+ Count and Plasma HIV-1 RNA Beyond Self-Reported Race and Ethnicity. J Acquir Immune Defic Syndr 71:544-50
Curtis, Donna J; Muresan, Petronella; Nachman, Sharon et al. (2015) Characterization of functional antibody and memory B-cell responses to pH1N1 monovalent vaccine in HIV-infected children and youth. PLoS One 10:e0118567
Marsit, Carmen J; Brummel, Sean S; Kacanek, Deborah et al. (2015) Infant peripheral blood repetitive element hypomethylation associated with antiretroviral therapy in utero. Epigenetics 10:708-16
Moodley, Amaran; Spector, Stephen A (2015) Single high-dose vitamin D at birth corrects vitamin D deficiency in infants in Mexico. Int J Food Sci Nutr 66:336-41
Aweeka, F T; Hu, C; Huang, L et al. (2015) Alteration in cytochrome P450 3A4 activity as measured by a urine cortisol assay in HIV-1-infected pregnant women and relationship to antiretroviral pharmacokinetics. HIV Med 16:176-83
Nachman, Sharon; Zheng, Nan; Acosta, Edward P et al. (2014) Pharmacokinetics, safety, and 48-week efficacy of oral raltegravir in HIV-1-infected children aged 2 through 18 years. Clin Infect Dis 58:413-22
Qin, Min; Brummel, Sean; Singh, Kumud K et al. (2014) Associations of host genetic variants on CD4⁺ lymphocyte count and plasma HIV-1 RNA in antiretroviral naïve children. Pediatr Infect Dis J 33:946-52

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