Clinical Sciences Core (C)

Miami CFAR Clinical Sciences Core

The Miami AIDS Clinical Trials Unit (ACTU) carries out clinical trials studying new treatments for HIV infection and HIV-related opportunistic infections including Hepatitis C novel treatment regimens.

The University of Miami Infectious Diseases Research Unit is located adjacent to the Special Immunology clinics. The Infectious Diseases Research unit is equipped with examination and interview rooms, a laboratory, and office space for study coordination. Services provided in the unit are: study coordination, biological sample collection and processing. This location next to the Special Immunology clinics allows recruiting participants in an efficient manner on the same day of clinic visit.

Miami International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Network carries out clinical trials for long-term complications of new anti-retrovirals for pediatric and adolescent populations and prevention of mother-to-child transmission of HIV


Aim 1. Provide state-of-the-art facilities for implementation of clinical studies, clinical research and services including sample and data collection and to facilitate training / education of investigators

Aim 2. Provide research design methodology and technical assistance to meet regulatory standards in research that involves human subjects, human data, and biological specimens

Aim 3. Provide research design and biostatistical support through a CFAR Biostatistics Sub-core

Dr. Alcaide

Maria Alcaide, M.D.

Research profile

Assoc. Professor of Clinical
Infectious Diseases

Dr. Alcaide is an Infectious Diseases specialist, Associate Professor of Clinical Medicine at the University of Miami, Miller School of Medicine, Director of the University of Miami Infectious Diseases Research Unit, and the Miami CFAR Clinical Core. Dr. Alcaide has clinical and research expertise in HIV, sexually transmitted infections, and other infectious diseases. She is the PI and co-investigator of multiple US and international research studies (South Africa, Zambia, Argentina) focused on HIV. In addition she is the PI and co-investigator of infectious diseases research on Zika though federal and state of Florida funding. As the Director of the CFAR clinical core, she facilitates the conduction of clinical research focused on HIV according to the Miami CFAR clinical core aims.

Dr. Fischl

Margaret Fischl, M.D., F.A.C.P.

Research Profile

Infectious Diseases

Dr. Fischl, professor of medicine and director, AIDS Clinical Research Unit, brings a depth of expertise in the clinical and therapeutic aspects of HIV and established knowledge of the University and the community. She has more than 20 years of experience in directing a large multidisciplinary HIV/AIDS research program that brings together faculty across multiple departments within the University. As the director of the unit since 1986, she has been responsible for the implementation of the program, the development of policies and procedures for the conduct of HIV/AIDS clinical trials, and identifying and prioritizing individual clinical trials and research projects. In her role as administrative associate director, Dr. Fischl will ensure that the scientific direction of the D-CFAR is pointed at the greatest challenges in clinical HIV disease and that the D-CFAR members are in compliance with all regulatory matters related to conduct of clinical studies.

Dr. Mithell

Charles Mitchell, MD

Research Profile

Pediatrics, Infectious Diseases

Dr. Charles D. Mitchell has been involved in research related to Pediatric AIDS for over 20 years having been an author or co-author of numerous papers and abstracts describing the results of both domestic and international studies on Pediatric AIDS. He is presently the Site Leader for the University of Miami Clinical Research Site(CRS) for the International Maternal, Pediatric, and Adolescent AIDS Clinical Trials(IMPAACT) and has played an active role in the continuing clinical trials involving the large population of HIV infected children who receive their primary care at UM. He currently is involved in 2 international studies in Africa: IMPAACT III study of the efficacy of primary INH prophylaxis in HIV exposed African infants">P1041 and a co-investigator of a long term NCI funded study of the epidemiology of Human Herpesvirus type 8(HHV8 or Kaposi’s Sarcoma Herpesvirus) in Zambia. He played a key role in developing the basic rationales, and study design for both of these projects. As Co-Director of the Clinical Core, he will draw upon his extensive experience in overseeing the operation of one of the largest clinical trials groups involving HIV affected children in the United States and knowledge of the regulatory guidelines that govern such an effort. He also possesses an extensive and up to date knowledge of the current research priorities in Pediatric HIV/AIDS.