Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)
2 other identifiers
interventional
60
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
June 1, 1990
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +1 more criteria
You may not qualify if:
- 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.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen, LPlead
Study Sites (3)
Dr Douglas Dieterich
New York, New York, 10016, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025, United States
Related Publications (2)
Connolly GM, Youle M, Gazzard BG. Diclazuril in the treatment of severe cryptosporidial diarrhoea in AIDS patients. AIDS. 1990 Jul;4(7):700-1. doi: 10.1097/00002030-199007000-00020. No abstract available.
PMID: 2397069BACKGROUNDSoave R, Dieterich D, Kotler D, Gassyuk E, Tierney AR, Liebes L, Legendre R. Oral diclazuril therapy for cryptosporidiosis. Int Conf AIDS. 1990 Jun 20-23;6(1):252 (abstract no ThB520)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1990-06