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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002027
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Tracking Information
First Submitted Date  ICMJE November 2, 1999
First Posted Date  ICMJE August 31, 2001
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)
Official Title  ICMJE Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Cryptosporidiosis
  • HIV Infections
Intervention  ICMJE Drug: Diclazuril
Study Arms  ICMJE Not Provided
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002027
Other Study ID Numbers  ICMJE 038A
JRD 64,433/1101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Janssen, LP
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NIH AIDS Clinical Trials Information Service
Verification Date June 1990

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