NCT00055107

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 hiv-infections

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2003

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

February 19, 2003

Last Update Submit

October 28, 2021

Conditions

HIV InfectionsCryptosporidiosis

Keywords

NitazoxanideAntiprotozoal AgentsCryptosporidiosisCryptosporidium parvumAIDS-Related Opportunistic InfectionsPharmacokineticsDrug Adminstration Schedule

Outcome Measures

Primary Outcomes (2)

  • 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

  • area under the curve (AUC) of orally administered NTZ

Secondary Outcomes (1)

  • 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

Interventions

NitazoxanideDRUG

Eligibility Criteria

Age3 Months - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stellenbosch Univ. CRS

Cape Town, 7505, South Africa

Location

Siriraj Hospital Mahidol University CRS

Bangkok, 10700, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 15482125BACKGROUND

  • 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.

    PMID: 11176565BACKGROUND

  • 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.

    PMID: 15612836BACKGROUND

  • 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.

    PMID: 15640710BACKGROUND

MeSH Terms

Conditions

HIV InfectionsCryptosporidiosisAIDS-Related Opportunistic Infections

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesIntestinal Diseases, ParasiticParasitic DiseasesProtozoan Infections, AnimalParasitic Diseases, AnimalCoccidiosisProtozoan InfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesAnimal DiseasesOpportunistic Infections

Study Officials

  • Myron Levin, MD

    Health Sciences Center, Pediatric Infectious Diseases, University of Colorado

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2003

First Posted

February 20, 2003

Study Completion

May 1, 2006

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

ZA(1)TH(1)