A Study of Letrazuril in the Treatment of AIDS-Related Diarrhea
NCT ID: NCT00001018
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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Four groups of eight patients receive escalating doses of oral letrazuril (or placebo). In each group, six patients are randomized to receive letrazuril and two patients receive matching placebo. In the pharmacokinetics determination phase of the study, patients receive a single dose of letrazuril or placebo following a meal. Following a 72-hour blood collection, patients enter the blinded, treatment phase of the study and receive letrazuril or placebo as a single dose daily, after a meal, for 3 weeks. Patients with persistent Cryptosporidium oocysts in their stools at the end of the blinded treatment phase may continue with open-label treatment of letrazuril at the same dose for 4 weeks; the dose may subsequently be escalated every 4 weeks, to a maximum, if oocysts persist. Patients who have Cryptosporidium oocysts eradicated from their stools will discontinue treatment and be followed for 3 months. All patients undergo clinical follow-up at 3 and 6 months.
Conditions
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Study Design
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TREATMENT
Interventions
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Letrazuril
Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
ALL
No
Sponsors
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Janssen Pharmaceuticals
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Moskovitz BL
Role: STUDY_CHAIR
Locations
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USC School of Medicine
Los Angeles, California, United States
Dr Douglas Dieterich
New York, New York, United States
Cornell Univ Med Ctr
New York, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States
Countries
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References
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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)
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.
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)
Other Identifiers
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Protocol JRD 65731/1001
Identifier Type: -
Identifier Source: secondary_id
ACTG 198
Identifier Type: -
Identifier Source: org_study_id