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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002027
• Other study ID #: 038A
• Secondary ID: JRD 64,433/1101
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cryptosporidiosis
• HIV Infections

Intervention

Drug:
• Diclazuril

Locations

Country	Name	City	State
United States	Cornell Univ Med Ctr	New York	New York
United States	Dr Douglas Dieterich	New York	New York
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Janssen, LP

Country where clinical trial is conducted

United States, 

References & Publications (2)

Connolly G, Youle M, Gazzard B. Diclazuril in the treatment of cryptosporidial diarrhoea in AIDS. Int Conf AIDS. 1990 Jun 20-23;6(2):384 (abstract no 2122)

Soave 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)