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

Launched by JANSSEN, LP · Aug 30, 2001

Keywords

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Gender

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Eligibility 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.