Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT00002027
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
65 Years
Study:
NCT00002027
Study Brief:
Protocol Section:
NCT00002027