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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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002027 on ClinicalTrials.gov Archive Site
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Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)
Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)

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.

Not Provided
Interventional
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Primary Purpose: Treatment
  • Cryptosporidiosis
  • HIV Infections
Drug: Diclazuril
Not Provided
  • 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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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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.
Both
12 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002027
038A, JRD 64,433/1101
Not Provided
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Janssen, LP
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NIH AIDS Clinical Trials Information Service
June 1990

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP