Miami Pediatric AIDS Clinical Trials Unit

Project: Research project

Project Details

Description

DESCRIPTION (provided by applicant): In this renewal application, the
Pediatric AIDS Clinical Trials Group Unit at the University of Miami School of
Medicine, composed of a functionally integrated Perinatal/Pediatric Research
Network of investigators from the Division of Pediatric Infectious Disease,
Adolescent Medicine and Obstetrics, proposes to contribute significantly to
the scientific agenda of the PACTG. We will continue to enroll large numbers
of HIV-1 infected women, children, and adolescents into PACTG sponsored
clinical trials. Approximately 150 patients will be enrolled during the first
year of the next funding cycle into one or more (1) Primary therapy studies,
(2) Opportunistic infection studies, (3) Perinatal intervention trials, (4)
Vaccine trials, and (5) Long-term observational protocols. Finally, the Miami
Unit will continue to maintain its excellent record in data management. This
Network is led by Dr. Gwendolyn Scott (P.I., Dept. of Pediatrics) and Dr. Mary
Jo O'Sullivan (Co-PI, Dept. of Obstetrics) both of whom are recognized
nationally and internationally for their expertise in HIV infection and have
an ongoing leadership role in the PACTG. Dr. Scott will be assisted in these
efforts by Drs. Lawrence Friedman and Charles Mitchell who will have the
responsibility of overseeing the enrollment of adolescents and children
younger than 13 respectively. The PACTG Network will continue to contribute to
the scientific agenda of the PACTG by developing new protocols, participating
in scientific committees, and assisting in the expansion of the scientific
endeavors of the PACTG in the developing world. The University of Miami has
been funded by the Fogarty International Center for the last decade and
presently has three Fogarty initiatives which provide research training for
international fellows (from Brazil, the Dominican Republic, and Zambia) in
Pediatric AIDS, Maternal and Child Health, and Medical Informatics. The
strength of the Miami Perinatal Research Network relates to (1) the expertise
of the faculty and their distinguished record in the conduct of clinical
trials, (2) an extensive infrastructure of psychosocial and medical support
which has facilitated the enrollment and retention of patients in clinical
trials at our site, (3) an outstanding record in data management (4) excellent
laboratory support from the PACTG Core Virology Laboratory and an ACTG
certified immunology laboratory, (5) a large population of HIV-1 infected
women, children, and adolescents, (6) outreach efforts that integrate with
community programs, and (7) International collaborations for expansion of
clinical trials.
StatusFinished
Effective start/end date12/31/892/28/07

Funding

  • National Institute of Allergy and Infectious Diseases: $1,336,540.00
  • National Institute of Allergy and Infectious Diseases: $686,001.00
  • National Institute of Allergy and Infectious Diseases
  • National Institute of Allergy and Infectious Diseases
  • National Institute of Allergy and Infectious Diseases: $1,167,578.00
  • National Institute of Allergy and Infectious Diseases
  • National Institute of Allergy and Infectious Diseases
  • National Institute of Allergy and Infectious Diseases
  • National Institute of Allergy and Infectious Diseases
  • National Institute of Allergy and Infectious Diseases: $1,461,812.00
  • National Institute of Allergy and Infectious Diseases: $391,546.00
  • National Institute of Allergy and Infectious Diseases: $999,382.00
  • National Institute of Allergy and Infectious Diseases
  • National Institute of Allergy and Infectious Diseases
  • National Institute of Allergy and Infectious Diseases
  • National Institute of Allergy and Infectious Diseases: $1,133,574.00
  • National Institute of Allergy and Infectious Diseases
  • National Institute of Allergy and Infectious Diseases

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