- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00055107
Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children
A Phase I/II Open Label Study of Nitazoxanide (NTZ) for the Treatment of Cryptosporidium Parvum in HIV Infected Infants, Children, and Adolescents
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
C. parvum is a significant opportunistic infection in much of the developing world, where children may not have access to highly active antiretroviral therapy. There is currently no established therapy for chronic cryptosporidiosis in HIV infected children. The FDA has approved NTZ for the treatment of cryptosporidiosis diarrhea; however, there are no data on the safety and effectiveness of NTZ in HIV infected children. The purpose of this study is to evaluate the safety of different doses of NTZ in HIV infected children with chronic diarrhea caused by C. parvum.
In Step 1, participants will receive one of four different doses of NTZ. Participants will take NTZ twice a day for 56 days in either a liquid or pill form. All participants will be closely monitored for drug toxicity. There will be seven study visits; they will occur at study entry, Weeks 1, 2, 4, 6, and 8, and Day 70. Study visits will include a physical exam and blood, urine, and stool collection. Pharmacokinetic (PK) sampling will be performed during four of the study visits. PK sampling requires the participants to take their morning NTZ doses while in the clinic; participants will undergo additional blood collection either before or after taking NTZ. At the end of the 56-day study period, participants who are experiencing a positive clinical benefit from NTZ and who have had no harmful side effects may choose to continue taking NTZ for an additional 24 weeks and enter Step 2. Participants who do not continue taking NTZ after Day 56 will be followed for 2 additional weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Cape Town, South Africa, 7505
- Stellenbosch Univ. CRS
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Bangkok, Thailand, 10700
- Siriraj Hospital Mahidol University CRS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for Step 1:
- HIV infected
- Chronic diarrhea with 3 or more bowel movements per day for at least 5 days in the 2 weeks prior to study entry OR 2 or more bowel movements per day for at least 5 days in the 2 weeks prior to study entry if accompanied by dehydration
- Documented presence of C. parvum oocysts in stool
- Weight of 4.0 kg (8.8 lbs) or more AND less than or equal to the maximum weight for age group as specified in the study protocol
- Parent or guardian willing to provide informed consent, if applicable
- Willing to use acceptable forms of contraception
Exclusion Criteria for Step 1:
- Inability to take liquid or tablet form of medication
- Serum transaminase (ALT) and bilirubin greater than or equal to 5 times the upper limit of normal at study screening
- Active M. avium intracellulare or cytomegalovirus (CMV) colitis
- Active cancer
- Certain medications
- Pregnant or breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety as evaluated by Grade 4 or new Grade 3 adverse reactions before Day 56 that cannot be directly attributed to another cause and are considered treatment limiting
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area under the curve (AUC) of orally administered NTZ
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Secondary Outcome Measures
Outcome Measure |
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Safety as evaluated by Grade 4 or new Grade 3 adverse reactions during longer-term follow-up (six months after Day 56 under Step I) that cannot be directly attributed to another cause and are considered treatment limiting
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Myron Levin, MD, Health Sciences Center, Pediatric Infectious Diseases, University of Colorado
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PACTG 369
- 10033 (Registry Identifier: DAIDS ES)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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