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Home > "A" Clinical Trials Conditions > A Study of Nitazoxanide in Patients with AIDS and Diarrhea Caused by Cryptosporidium  A Study of Nitazoxanide in Patients with AIDS and Diarrhea Caused by Cryptosporidium
A Study of Nitazoxanide in Patients with AIDS and Diarrhea Caused by Cryptosporidium
For Condition: Cryptosporidiosis,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the frequency of complete, marked, and partial clinical responses in patients with cryptosporidiosis treated with 6 weeks of NTZ versus 21 days of placebo. To determine the safety of NTZ in subjects with cryptosporidiosis. There is no proven therapy for cryptosporidiosis in persons with AIDS. Nitazoxanide appears to be a good candidate drug for further evaluation because of its effectiveness in preclinical models, the data from early clinical trials and its safety profile. Cooperation between clinical researchers and basic scientists in clinical trials of agents for HIV infection and its complications is a high priority for the ACTG, the NIAID, and the NIH. Thus, it is important to design a clinical trial of NTZ that includes cooperation with basic scientists.
Details: There is no proven therapy for cryptosporidiosis in persons with AIDS. Nitazoxanide appears to be a good candidate drug for further evaluation because of its effectiveness in preclinical models, the data from early clinical trials and its safety profile. Cooperation between clinical researchers and basic scientists in clinical trials of agents for HIV infection and its complications is a high priority for the ACTG, the NIAID, and the NIH. Thus, it is important to design a clinical trial of NTZ that includes cooperation with basic scientists. Patients will be randomized to the active drug or placebo in a 2:1 ratio. Patients will be stratified by presence or absence of dual infection with microsporidiosis and screening CD4+ count (<= 50/mm3, > 50/mm3). Days 1 - 21, Arm I will receive oral NTZ and Arm II will receive NTZ placebo po bid (blinded). With the approval of the protocol chair, patients may switch to open-label NTZ after two weeks of blinded therapy if there is a clinical worsening of diarrhea due to cryptosporidiosis accompanied by either weight loss >= 5% or the requirement for intravenous fluids to maintain body weight and/or intravascular volume despite the use of appropriate antidiarrheal agents. Days 22 - 42, Arm I and Arm II will receive oral NTZ (open-label). Days 43 - 63, Arm I will begin the maintenance phase and Arm II will receive oral NTZ (open-label). On Day 63 Arm II will start the maintenance phase. In maintenance phase patients will be randomized to 1 of 2 doses of NTZ 24 weeks. Patients who are not complete or marked responders at Day 42 (Arm I) or Day 63 (Arm II) may receive a higher dose of NTZ for an additional three weeks. Patients who have a complete or marked response at the higher dose may initiate maintenance therapy. Patients who continue to have only a partial response or who fail to respond will discontinue therapy.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Documented HIV infection. - Intestinal cryptosporidiosis. - Willingness to undergo a 1 week washout phase of all anticryptosporidial medications and stabilization on a protocol directed, antidiarrheal regimen. - Greater than or equal to 4 stools per day, on average, for a minimum of 21 out of 28 days prior to study entry, secondary to cryptosporidiosis. AS PER AMENDMENT 2/10/97: - Four or more stools per day, on average, during the 5-day screening period prior to baseline. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Inability to tolerate oral medications. - Life expectancy less than 3 months in the opinion of the investigator. - Active CMV colitis, C. difficile colitis, giardiasis, salmonellosis, shigellosis, campylobacteriosis, inflammatory bowel disease, diarrhea secondary to another documented intestinal pathogen, or active or uncontrolled MAC disease, defined as symptomatic MAC disease and/or a patient who is not on appropriate anti-MAC therapy in the presence of MAC disease. NOTE: - Patients who have been treated for MAC disease for at least 4 weeks and have resolved their symptoms may be enrolled. Patients dually infected with microsporidiosis may be randomized to the study but will not count toward the sample size. AS PER AMENDMENT 2/10/97: - Failure to record a minimum of four days of information on the use of antidiarrheal medication and the frequency of bowel movements in the daily diary during the screening period. - Allergy to corn or corn products. Concurrent Medication: Excluded: - Need for continuing use of any medications with putative anticryptosporidial activity, including paromomycin, azithromycin, clarithromycin, spiramycin, bovine colostrum, monoclonal anticryptosporidial antibody preparations, letrazuril, atovaquone, diclazuril, octreotide and albendazole (prohibited during the acute treatment phase for patients dually infected with microsporidiosis).. NOTE: - Patients who develop cryptosporidiosis while taking azithromycin or clarithromycin may be enrolled as long as they have been taking those medications for at least four weeks and remain on a stable dosage. - All antidiarrheals that are not part of the protocol directed Antidiarrheal Stabilization Regimen. - The addition of any new antiretroviral agent or immunomodulator therapy the first 63 days on the study. Prior Medication: Excluded: - Treatment at any time prior with nitazoxanide. - Addition of any new antiretroviral or increase in the dosage or current antiretrovirals within 4 weeks to study entry.
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
FichtenbaumC, Study Chair,
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Additional Information:
Study ID Numbers: ACTG 336;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001081
Other Cryptosporidiosis Studies:
1. Treatment of Chronic Cryptosporidiosis in AIDS Patients
2. A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis (Diarrhea Caused by the Parasite Cryptosporidium)
3. A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium Enteritis in AIDS Patients
4. Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
5. Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients
Related Studies:
Other Cryptosporidiosis Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
A Study of Nitazoxanide in Patients with AIDS and Diarrhea Caused by Cryptosporidium
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