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Study 13 of 19 for search of: | "Cryptosporidiosis" |
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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00055107 |
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.
Condition | Intervention | Phase |
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HIV Infections Cryptosporidiosis |
Drug: Nitazoxanide |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | A Phase I/II Open Label Study of Nitazoxanide (NTZ) for the Treatment of Cryptosporidium Parvum in HIV Infected Infants, Children, and Adolescents |
Estimated Enrollment: | 54 |
Study Completion Date: | May 2007 |
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.
Ages Eligible for Study: | 3 Months to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for Step 1:
Exclusion Criteria for Step 1:
South Africa | |
University of Cape Town-Red Cross Children's Hospital | |
Cape Town, South Africa, 7700 | |
South Africa, Cape Town | |
University of Stellenbosch-Tygerberg Hospital | |
Tygerberg, Cape Town, South Africa, 7700 | |
Thailand | |
Siriraj Hospital | |
Bangkok, Thailand, 10700 |
Study Chair: | Myron Levin, MD | Health Sciences Center, Pediatric Infectious Diseases, University of Colorado |
Study ID Numbers: | PACTG 369 |
Study First Received: | February 19, 2003 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00055107 |
Health Authority: | United States: Food and Drug Administration |
Nitazoxanide Antiprotozoal Agents Cryptosporidiosis Cryptosporidium parvum |
AIDS-Related Opportunistic Infections Pharmacokinetics Drug Adminstration Schedule |
Protozoan Infections Opportunistic Infections Sexually Transmitted Diseases, Viral Diarrhea Gastrointestinal Diseases Acquired Immunodeficiency Syndrome Intestinal Diseases Immunologic Deficiency Syndromes Virus Diseases |
Cryptosporidiosis Digestive System Diseases HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Parasitic Diseases Nitazoxanide Intestinal Diseases, Parasitic Retroviridae Infections |
Anti-Infective Agents Antiparasitic Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Coccidiosis |
Therapeutic Uses Lentivirus Infections Parasitic Diseases, Animal Protozoan Infections, Animal Infection Pharmacologic Actions |