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Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children Clinical research trials and Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children. Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children clinical trial. Human subjects often obtain the finest healthcare possible for their Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "N" Clinical Trials Conditions > Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children  Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children
Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children
For Condition: HIV Infections,Cryptosporidiosis
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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. This study will test the safety of giving NTZ to HIV infected children who have chronic diarrhea caused by C. parvum.
Details: C. parvum is a significant opportunistic infection in much of the developing world, where children may not have access to highly active antiretroviral therapy (HAART). There is currently no established therapy for chronic cryptosporidiosis in HIV infected children. The United States Food and Drug Administration (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. Participants in this study 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. Participants will have seven study visits. Study visits will include a physical exam and blood, urine, and stool tests. Pharmacokinetic (PK) sampling will be performed during four of the study visits. PK sampling requires the participants to take their NTZ doses while in the clinic; participants then have additional blood testing either before or after taking the NTZ. At the end of the 56 day study period, participants who are experiencing a positive clinical benefit from the NTZ and who have had no harmful side effects may choose to continue taking NTZ for an additional 24 weeks. Participants who do not continue taking NTZ after Day 56 will be followed for 2 additional weeks.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 6 Months/19 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HIV infection - Chronic diarrhea (>= 6 bowel movements per day for a minimum of 2 weeks) - Documented presence of C. parvum oocysts in stool - Weight > 13.2 lbs for all cohorts and weight < 195 lbs for Cohort 1, 2, and 9; < 147 lbs for Cohort 3 and 4; < 117 lbs for Cohort 5 and 6; and < 98 lbs for Cohort 7 and 8 - Acceptable methods of contraception for participants of child-bearing potential Exclusion Criteria - Inability to take liquid or tablet form of medication - Serum transaminases (AST and ALT), bilirubin, and gamma-glutamyltranspeptidase (GGT) >= 5 X the upper limit of normal at study enrollment - Active M. avium intracellulare or cytomegalovirus (CMV) colitis - Active malignancy - Certain medications - Uncertain availability for 3 month study duration - Pregnant or breastfeeding
Total Enrollment: 72
Location and Contact Information:
Overall Study Official:
MyronLevin, Study Chair, University of Colorado
University of Stellenbosch-Tygerberg Hospital
Tygerberg, Cape Town, 7700
South Africa
Joan Coetzee 01-278-327-59577
Additional Information:
Study ID Numbers: PACTG 369;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055107
Other Cryptosporidiosis Studies:
1. A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy
2. A Study of Tumor Necrosis Factor and Human Interferon-gamma in Patients with AIDS Related Complex
3. A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
4. Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients
5. A Study of the Side Effects of L-743,872 in Men with Candidal Esophagitis
Related Studies:
Other Cryptosporidiosis Clinical Trials
Other Cape Town Clinical Trials
Other Tygerberg Clinical Trials
Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children
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