A Phase 2A Evaluation of the Safety, Tolerability, Pharmacokinetics, Efficacy of Clofazimine (CFZ) in Cryptosporidiosis
Status:
Terminated
Trial end date:
2019-07-05
Target enrollment:
Participant gender:
Summary
This study evaluates the safety, tolerability, pharmacokinetics, and efficacy of treating
Cryptosporidiosis in HIV positive patients with Clofazimine. Half of the HIV positive
patients with Cryptosporidiosis enrolled will be treated with Clofazimine while the other
half will be given placebo. An additional group of HIV positive patients without
Cryptosporidium infection or diarrhea will be given Clofazimine to assess the differences in
pharmacokinetics between HIV positive patients with and without Cryptosporidiosis and
diarrhea.
Phase:
Phase 2
Details
Lead Sponsor:
University of Washington
Collaborators:
Bill and Melinda Gates Foundation Calibr, a division of Scripps Research California Institute for Biomedical Research Liverpool School of Tropical Medicine Malawi-Liverpool-Wellcome Trust Clinical Research Programme The Emmes Company, LLC The EMMES Corporation University of Virginia