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A 28-Day Study of Diclazuril in the Treatment of Cryptosporidiosis in Patients with AIDS



A 28-Day Study of Diclazuril in the Treatment of Cryptosporidiosis in Patients with AIDS

For Condition: Cryptosporidiosis,HIV Infections
Status: Completed
Sponsor(s): Janssen Pharmaceutica ,
Synopsis: To evaluate the safety and efficacy of diclazuril capsules as a treatment for cryptosporidial related diarrhea in AIDS patients who have been treated in the double-blind study # JRD 64,433/1101 and have relapsed, or de-novo patients who have been diagnosed with cryptosporidial related diarrhea and who meet the inclusion and exclusion criteria of this protocol.
Details:
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Zidovudine (AZT). - Didanosine (ddI) allowed but discouraged, must have been stabilized on a constant dose for 3 weeks or more. - Aerosolized pentamidine. - Nystatin for control of oropharyngeal infections. Nystatin must not be taken within two hours of diclazuril. - Ganciclovir therapy only for CMV retinitis is permitted if the patient has been treated for at least 4 weeks prior to study entry and is stable on the drug. - Loperamide may be taken if patient has been on long term loperamide prior to study entry but should not be started during the course of this protocol. Patients must have the following: Written informed consent given after the purpose and nature of the study, as well as the possible adverse effects related to the study drug, have been explained. - Be willing and able to return for all subsequent weekly visits and the two week visit post completion of therapy (follow-up). Prior Medication: Allowed: - Diclazuril. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Uncontrolled vomiting. - Estimated survival less than 28 days. - Other treatable enteric pathogens must be treated and eradicated prior to study entry. Concurrent Medication: Excluded: - Amphotericin B. - Other antibiotics or antiprotozoal drugs. - Other investigational agents. - Trimethoprim/sulfamethoxazole. - Antifungal medications except nystatin. - Ganciclovir for other than Cytomegalovirus (CMV) retinitis. - Antidiarrheal agents other than patients on long term loperamide prior to study entry. Patients with the following are excluded: - Undependable in following the instructions of the investigator. - Not able to swallow capsules. - Uncontrolled vomiting. - Estimated survival less than 28 days. Prior Medication: Excluded: - Diclazuril within 2 weeks of study entry.
Total Enrollment: 

Location and Contact Information:

Saint Luke's - Roosevelt Hosp Ctr
New York City,  New York,  10025
United States
 

Cornell Univ Med Ctr
New York City,  New York,  10021
United States
 

Bellevue Hosp / New York Univ Med Ctr
New York City,  New York,  10016
United States
 


Additional Information:
Study ID Numbers:  038B;  JRD 64,433/1102
Study Start Date: 
Record last reviewed: July 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002278

Other Cryptosporidiosis Studies:
1. Cidofovir as a Treatment for Herpes Simplex in Patients with AIDS

2. A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.

3. A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Large Intestine in Patients with AIDS

4. A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols

5. The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-dideoxyinosine or 2',3'-dideoxycytidine in Patients with Human Immunodeficiency Virus Disease

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