Status:

COMPLETED

A Study of Letrazuril in the Treatment of AIDS-Related Diarrhea

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Janssen Pharmaceuticals

Conditions:

Cryptosporidiosis

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

PHASE1

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 letra...

Detailed Description

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 need...

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT00001018

Last Update

June 24 2005

Active Locations (4)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (4 locations)

1

USC School of Medicine

Los Angeles, California, United States, 90033

2

Dr Douglas Dieterich

New York, New York, United States, 10016

3

Cornell Univ Med Ctr

New York, New York, United States, 10021

4

Saint Luke's - Roosevelt Hosp Ctr

New York, New York, United States, 10025