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

NCT ID: NCT00002027

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL

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.

Conditions

Cryptosporidiosis; HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Diclazuril

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen, LP

INDUSTRY

Sponsor Role: lead

Locations

Dr Douglas Dieterich

New York, New York, United States

Cornell Univ Med Ctr

New York, New York, United States

Saint Luke's - Roosevelt Hosp Ctr

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 2397069 (View on PubMed)

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)

Reference Type: BACKGROUND

Other Identifiers

JRD 64,433/1101

Identifier Type: -

Identifier Source: secondary_id

038A

Identifier Type: -

Identifier Source: org_study_id