drugset / Trial / NCT03341767
A Phase 2A Evaluation of the Safety, Tolerability, Pharmacokinetics, Efficacy of Clofazimine (CFZ) in Cryptosporidiosis
Phase 2
Terminated
33 enrolled
University of Washington
Bill and Melinda Gates Foundation · collabCalibr, a division of Scripps Research · collabLiverpool School of Tropical Medicine · collabMalawi-Liverpool-Wellcome Trust Clinical Research Programme · collabThe Emmes Company, LLC · collabUniversity of Virginia · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2017-12-14
- Primary completion
- 2019-04-01
- Completion
- 2019-07-05
Publications
- Background Love MS, Beasley FC, Jumani RS, Wright TM, Chatterjee AK, Huston CD, Schultz PG, McNamara CW. A high-throughput phenotypic screen identifies clofazimine as a potential treatment for cryptosporidiosis. PLoS Negl Trop Dis. 2017 Feb 3;11(2):e0005373. doi: 10.1371/journal.pntd.0005373. eCollection 2017 Feb.
- Zhang CX, Love MS, McNamara CW, Chi V, Woods AK, Joseph S, Schaefer DA, Betzer DP, Riggs MW, Iroh Tam PY, Van Voorhis WC, Arnold SLM. Pharmacokinetics and Pharmacodynamics of Clofazimine for Treatment of Cryptosporidiosis. Antimicrob Agents Chemother. 2022 Jan 18;66(1):e0156021. doi: 10.1128/AAC.01560-21. Epub 2021 Nov 8.
- Iroh Tam P, Arnold SLM, Barrett LK, Chen CR, Conrad TM, Douglas E, Gordon MA, Hebert D, Henrion M, Hermann D, Hollingsworth B, Houpt E, Jere KC, Lindblad R, Love MS, Makhaza L, McNamara CW, Nedi W, Nyirenda J, Operario DJ, Phulusa J, Quinnan GV, Sawyer LA, Thole H, Toto N, Winter A, Van Voorhis WC. Clofazimine for Treatment of Cryptosporidiosis in Human Immunodeficiency Virus Infected Adults: An Experimental Medicine, Randomized, Double-blind, Placebo-controlled Phase 2a Trial. Clin Infect Dis. 2021 Jul 15;73(2):183-191. doi: 10.1093/cid/ciaa421.
- Nachipo P, Hermann D, Quinnan G, Gordon MA, Van Voorhis WC, Iroh Tam PY. Evaluating the safety, tolerability, pharmacokinetics and efficacy of clofazimine in cryptosporidiosis (CRYPTOFAZ): study protocol for a randomized controlled trial. Trials. 2018 Aug 23;19(1):456. doi: 10.1186/s13063-018-2846-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clofazimine | Small molecule | 50 mg | Oral |
| Subject | Clofazimine | Small molecule | 100 mg | Oral |