Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)

Launched by JANSSEN, LP · Aug 30, 2001

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Eligibility 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.