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Home > "P" Clinical Trials Conditions > Protocol For the Treatment of Cryptosporidiosis in AIDS Patients with Diclazuril (R64,433)  Protocol For the Treatment of Cryptosporidiosis in AIDS Patients with Diclazuril (R64,433)
Protocol For the Treatment of Cryptosporidiosis in AIDS Patients with Diclazuril (R64,433)
For Condition: Cryptosporidiosis,HIV Infections
Status: Completed
Sponsor(s): Janssen Pharmaceutica ,
Synopsis: To evaluate the safety and efficacy of diclazuril capsules compared with placebo capsules as treatment of cryptosporidial related diarrhea in AIDS patients. Treatment efficacy will be based on the drug's clinical results and on its anti-protozoan effects. Safety will be assessed by the occurrence of side effects as reported by patients at their visits and by frequent monitoring of hematology, biochemistries, and urinalysis.
Details:
Eligibility:
Study Type: Interventional, Treatment, Placebo Control
Minimum Age/Maximum Age: 12 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Patients who require anti-diarrheal medication must have received only one anti-diarrheal medication, loperamide, for at least 7 days prior to study entry. Dose of loperamide cannot be increased during study. - Aerosolized pentamidine. - Ganciclovir for cytomegalovirus (CMV) retinitis only but patient must be stable at least 4 weeks prior to study entry. - Zidovudine (AZT). - Nystatin for oropharyngeal infections if not taken within 2 hours of diclazuril. Patients must have: - Diagnosis of AIDS that is confirmed HIV positive by Western blot or AIDS defined diagnosis, or CDC defined AIDS. Stool specimens positive for cryptosporidium oocysts. - Given written informed consent after the purpose and nature of the study, as well the possible drug-related adverse effects, have been explained. - Ability to return for all subsequent applicable visits on days 8, 15, 21, and, if necessary, 28. Prior Medication: Allowed: - Aerosolized pentamidine. - Loperamide. - Ganciclovir for cytomegalovirus (CMV) retinitis. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Diagnosis of cryptosporidiosis less than 4 weeks prior to study entry, unless patient has been diagnosed with AIDS for more than 4 weeks. - Other treatable enteric pathogens including Clostridia must be treated and eradicated prior to study entry. - Inability to swallow capsules. - Uncontrolled vomiting. Concurrent Medication: Excluded: - Trimethoprim/sulfamethoxazole (Bactrim). - Ganciclovir for any other reason except cytomegalovirus (CMV) retinitis. - Other antibiotics. - Other anti-protozoal drugs. - Anti-fungal drugs other than nystatin. - Amphotericin B. - Other investigational drugs. Patients with the following are excluded: - Diagnosis of cryptosporidiosis less than 4 weeks prior to study entry, unless patient has been diagnosed with AIDS for more than 4 weeks. - Inability to swallow capsules. - Uncontrolled vomiting. - Life expectancy of < 28 days. - Can not be depended upon to follow the instructions of the investigator. - Participation in an investigational study within 15 days of study entry. Prior Medication: Excluded within 15 days of study entry: - Another investigational drug or device (except aerosolized pentamidine). Prior Treatment: Excluded within 15 days of study entry: - Participation in an investigational study.
Total Enrollment: 60
Location and Contact Information:
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Dr Douglas Dieterich
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: 038A; JRD 64,433/1101
Study Start Date:
Record last reviewed: June 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002027
Other Hiv Infections Studies:
1. Lamivudine and Adefovir to Treat Chronic Hepatitis B Infection in People With and Without HIV Infection
2. Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
3. A Randomized, Placebo-Controlled Study of the Safety and Efficacy of Efavirenz, Didanosine, and Stavudine in Combination With or Without Hydroxyurea in Antiretroviral Naive or Experienced HIV-Infected Patients
4. Phase II Study of the Safety and Surrogate Marker Efficacy of Butyldeoxynojirimycin (SC-48334) and AZT in Symptomatic HIV-1 Infected Patients with 200 - 500 CD4+ Cells/mm3. (NOTE: Asymptomatic HIV-1 Infected Patients Also Eligible)
5. Interleukin-2 Plus Anti-HIV Therapy in HIV-Infected Children with Weakened Immune Systems
Related Studies:
Other HIV Infections Clinical Trials
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Other New York City Clinical Trials
Protocol For the Treatment of Cryptosporidiosis in AIDS Patients with Diclazuril (R64,433)
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