drugset / Trial / NCT00055107
Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children
Phase 1/2
Completed
6 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Cryptosporidium parvum (C. parvum) is a parasite that can cause chronic diarrhea and is a significant problem for HIV infected children in developing countries. C. parvum infection can be treated with the drug nitazoxanide (NTZ). However, NTZ has not been tested in HIV infected children. The purpose of this study is to test the safety of NTZ in HIV infected children who have chronic diarrhea caused by C. parvum. Study hypothesis: Twice-daily NTZ is safe and well tolerated in HIV infected infants, children, and adolescents with chronic diarrhea caused by C. parvum infection.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- 2006-05
Publications
- Background Armson A, Thompson RC, Reynoldson JA. A review of chemotherapeutic approaches to the treatment of cryptosporidiosis. Expert Rev Anti Infect Ther. 2003 Aug;1(2):297-305. doi: 10.1586/14787210.1.2.297.
- Background Dankner WM, Lindsey JC, Levin MJ; Pediatric AIDS Clinical Trials Group Protocol Teams 051, 128, 138, 144, 152, 179, 190, 220, 240, 245, 254, 300 and 327. Correlates of opportunistic infections in children infected with the human immunodeficiency virus managed before highly active antiretroviral therapy. Pediatr Infect Dis J. 2001 Jan;20(1):40-8. doi: 10.1097/00006454-200101000-00008.
- Background Guarino A, Bruzzese E, De Marco G, Buccigrossi V. Management of gastrointestinal disorders in children with HIV infection. Paediatr Drugs. 2004;6(6):347-62. doi: 10.2165/00148581-200406060-00003.
- Background Smith HV, Corcoran GD. New drugs and treatment for cryptosporidiosis. Curr Opin Infect Dis. 2004 Dec;17(6):557-64. doi: 10.1097/00001432-200412000-00008.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nitazoxanide | Other / unclassified | — | — |