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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002027
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1990
  Purpose

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.


Condition Intervention
Cryptosporidiosis
HIV Infections
Drug: Diclazuril

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 60
  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002027

Locations
United States, New York
Cornell Univ Med Ctr
New York, New York, United States, 10021
Dr Douglas Dieterich
New York, New York, United States, 10016
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10025
Sponsors and Collaborators
Janssen, LP
  More Information

Publications:
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)

ClinicalTrials.gov Identifier: NCT00002027     History of Changes
Other Study ID Numbers: 038A, JRD 64,433/1101
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Cryptosporidiosis
Diarrhea
diclazuril
Coccidiostats
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Cryptosporidiosis
HIV Infections
Infection
Coccidiosis
Digestive System Diseases
Gastrointestinal Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Intestinal Diseases
Intestinal Diseases, Parasitic
Lentivirus Infections
Parasitic Diseases
Parasitic Diseases, Animal
Protozoan Infections
Protozoan Infections, Animal
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Diclazuril
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Coccidiostats
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014