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A Phase 2A Evaluation of the Safety, Tolerability, Pharmacokinetics, Efficacy of Clofazimine (CFZ) in Cryptosporidiosis

NCT03341767 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-08-13

No results posted yet for this study

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.

Conditions

  • Cryptosporidiosis

Interventions

DRUG

Clofazimine

50 or 100 mg micronized Clofazimine suspended in an oil-wax base in a gelatin capsule

DRUG

Placebo

Oil-wax in gelatin capsule

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • Calibr, a division of Scripps Research

    collaborator OTHER

  • Liverpool School of Tropical Medicine

    collaborator OTHER

  • University of Virginia

    collaborator OTHER

  • Malawi-Liverpool-Wellcome Trust Clinical Research Programme

    collaborator OTHER

  • University of Washington

    lead OTHER

Principal Investigators

  • Wes Van Voorhis, MD, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-14
Primary Completion
2019-04-01
Completion
2019-07-05

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03341767 on ClinicalTrials.gov