Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children

NCT ID: NCT00055107

Last Updated: 2021-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2006-05-31

Brief 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.

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.

Conditions

HIV Infections; Cryptosporidiosis

Keywords

Nitazoxanide; Antiprotozoal Agents; Cryptosporidiosis; Cryptosporidium parvum; AIDS-Related Opportunistic Infections; Pharmacokinetics; Drug Adminstration Schedule

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Nitazoxanide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myron Levin, MD

Role: STUDY_CHAIR

Health Sciences Center, Pediatric Infectious Diseases, University of Colorado

Locations

Stellenbosch Univ. CRS

Cape Town, , South Africa

Siriraj Hospital Mahidol University CRS

Bangkok, , Thailand

Countries

South Africa; Thailand

References

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.

Reference Type: BACKGROUND

PMID: 15482125 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11176565 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15612836 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15640710 (View on PubMed)

Other Identifiers

10033

Identifier Type: REGISTRY

Identifier Source: secondary_id

PACTG 369

Identifier Type: -

Identifier Source: org_study_id