IGF::OT::IGF HIV CLINICAL RESEARCH IN WEST AFRICA

Leidos Biomedical Research, Inc., Frederick MD

Investigators

Abstract

During the National Institute of Allergy and Infectious Diseases (NIAID)/Division of Clinical Research (DCR) support of studies of the pathogenesis, treatment and prevention of Ebola virus disease in West Africa, DCR noted an unexpectedly high (5%) prevalence of HIV infection. This provides a new opportunity to support the study of the manifestations of HIV infection in West Africa leveraging the infrastructure put in place to study Ebola. Among the questions that may be able to be addressed are: what are the clinical manifestations of HIV infection in West Africa with an emphasis on documented opportunistic diseases; what subtypes of HIV-1 and -2 are present in the population and are there different clinical and immunologic manifestations with different subtypes; what is the response to different treatment regimens and what is the prevalence of drug resistant mutations; and what are the responses to experimental vaccines for HIV. The requirements of this project are intended to provide the capacity necessary for Leidos Biomedical/CMRP to facilitate the conduct of research protocols related to the manifestations of HIV infection in West Africa. NIAID has assigned requirements for Leidos to support the conduct the studies, whereby Leidos will: 1. Provide scientific, clinical, and technical leadership 2. Procure all materials and supplies necessary to complete the protocols 3. Be responsible for program/project management in the areas of: a. Clinical research management b. Data management c . Biostatistical analysis and reporting.