NCT00001018

Brief Summary

To determine the pharmacokinetic profile of single doses of letrazuril in patients with AIDS-related cryptosporidial diarrhea; to determine the dose proportionality of single escalating doses of letrazuril; to determine steady-state concentrations of letrazuril; to evaluate the safety and efficacy of escalating doses of letrazuril, compared with placebo, for patients with AIDS-related cryptosporidial diarrhea. Letrazuril, the p-fluor analog of diclazuril, has been shown in an animal model to prevent infections by organisms closely related to the intracellular parasite Cryptosporidium. Reliable data are needed to show the effectiveness of letrazuril in treating AIDS-related cryptosporidial diarrhea.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

October 1, 1992

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

CryptosporidiosisHIV Infections

Keywords

CryptosporidiosisDiarrheaAcquired Immunodeficiency SyndromeAntiprotozoal AgentsTriazines

Interventions

LetrazurilDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Anti-diarrheal and antiemetic medications.
  • Anti-HIV agents such as zidovudine, ddI, and ddC if dosing regimens were stable for at least 3 weeks prior to start of study drug.
  • Patients must have:
  • AIDS.
  • Chronic diarrhea with presence of Cryptosporidium oocysts in a stool specimen.
  • CD4 count \< 150/mm3 (not required if patient has had cryptosporidiosis for a minimum of 4 weeks).
  • Life expectancy of at least 1 month.
  • Prior Medication:
  • Allowed:
  • Anti-HIV agents such as zidovudine, ddI, and ddC if dosing regimens were stable for at least 3 weeks prior to start of study drug.
  • Anti-diarrheal and antiemetic medications.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Grade 4 hematologic toxicity or grade 3 other toxicity ( patients with grade 3 hepatic toxicity may be enrolled if abnormalities are considered to be caused by biliary cryptosporidiosis).
  • Presence of other diarrhea-causing pathogens.
  • Active (defined as newly diagnosed, progressive, or requiring therapeutic intervention) opportunistic infection that requires antimicrobial therapy (patients receiving maintenance or prophylactic antimicrobial therapy for opportunistic infection may be enrolled if the dosing regimen has been stable for at least 3 weeks).
  • Evidence of cytomegalovirus retinitis or colitis.
  • Concurrent Medication:
  • Excluded:
  • Ganciclovir, cancer chemotherapy, or interferon-alpha or other immunomodulating agents.
  • Any investigational drug (drugs available under an FDA-authorized expanded access program will not be considered investigational).
  • Prior Medication:
  • Excluded:
  • Any investigational drug within 1 month prior to start of study drug (drugs available under an FDA-authorized expanded access program will not be considered investigational).
  • Ganciclovir, cancer chemotherapy, or interferon-alpha or other immunomodulating agents within 7 days prior to start of study drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

USC School of Medicine

Los Angeles, California, 90033, United States

Location

Dr Douglas Dieterich

New York, New York, 10016, United States

Location

Cornell Univ Med Ctr

New York, New York, 10021, United States

Location

Saint Luke's - Roosevelt Hosp Ctr

New York, New York, 10025, United States

Location

Related Publications (3)

  • Guillem S, Gomez M, Romeu J, Raventos A, Fernandez A, Condom MJ, Clotet B. Letrazuril for the treatment of severe cryptosporidial diarrhoea in AIDS. Int Conf AIDS. 1992 Jul 19-24;8(2):B129 (abstract no PoB 3257)

    BACKGROUND

  • Harris M, Deutsch G, MacLean JD, Tsoukas CM. A phase I study of letrazuril in AIDS-related cryptosporidiosis. AIDS. 1994 Aug;8(8):1109-13. doi: 10.1097/00002030-199408000-00011.

    PMID: 7986407BACKGROUND

  • Rubbert A, Schwab J, Kalden JR, Nusslein H. Myositis, fever, rash and thrombopenia after letrazuril treatment of intestinal cryptosporidiosis: a case report. Int Conf AIDS. 1993 Jun 6-11;9(1):373 (abstract no PO-B10-1430)

    BACKGROUND

MeSH Terms

Conditions

CryptosporidiosisHIV InfectionsDiarrheaAcquired Immunodeficiency Syndrome

Interventions

letrazuril

Condition Hierarchy (Ancestors)

Intestinal Diseases, ParasiticParasitic DiseasesInfectionsProtozoan Infections, AnimalParasitic Diseases, AnimalCoccidiosisProtozoan InfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesAnimal DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsSlow Virus Diseases

Study Officials

  • Moskovitz BL

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1992-10

Locations

US(4)