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Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study

Last updated on October 14, 2019

FOR MORE INFORMATION
Study Location
Infectious Disease Med Group
Oakland, California, 94609 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cryptosporidiosis, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Concurrent Medication:

Allowed:

- Zidovudine.

- Antidiarrheal medication with imodium or paregoric only.

Patients must have:

- HIV infection.

- Intestinal cryptosporidiosis proven by stool microscopy on at least two occasions
prior to study enrollment.

- Life expectancy of at least 2 weeks by clinical assessment. In states where the legal
age of consent for medical procedures is 21 years, patients below the age of 21 must
have consent of parent or guardian.

Prior Medication:

Allowed:

- Zidovudine.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

- Known hypersensitivity or significant intolerance to macrolide antibiotics.

- Marked abnormalities of liver or renal function.

- Causes for diarrhea other than, or in addition to, cryptosporidiosis.

- Inability to receive oral medication.

Concurrent Medication:

Excluded:

- Cancer chemotherapy (including therapy for Kaposi's sarcoma).

- Any drug or biologic preparation (e.g., bovine colostrum, paromomycin, spiramycin,
somatostatin) with possible anticryptosporidial activity.

- Immunostimulant or lymphocyte replacement therapy.

Prior Medication:

Excluded:

- Another investigational drug within 7 days prior to study enrollment (investigational
medications available through a treatment IND will be allowed with the approval of
the sponsor, the treatment IND sponsor, and the Pfizer clinical monitor).

- Immunostimulant or lymphocyte replacement therapy.

- Cancer chemotherapy (including therapy for Kaposi's sarcoma).

Not expected to comply with the requirements of the protocol, in the opinion of the
investigator.

NCT00002082
Pfizer
Completed
Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study

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Descriptive Information
Brief Title  ICMJE Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study
Official Title  ICMJE Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study
Brief SummaryTo evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Cryptosporidiosis
  • HIV Infections
Intervention  ICMJE Drug: Azithromycin
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   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 Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Zidovudine.
  • Antidiarrheal medication with imodium or paregoric only.

Patients must have:

  • HIV infection.
  • Intestinal cryptosporidiosis proven by stool microscopy on at least two occasions prior to study enrollment.
  • Life expectancy of at least 2 weeks by clinical assessment. In states where the legal age of consent for medical procedures is 21 years, patients below the age of 21 must have consent of parent or guardian.

Prior Medication:

Allowed:

  • Zidovudine.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Known hypersensitivity or significant intolerance to macrolide antibiotics.
  • Marked abnormalities of liver or renal function.
  • Causes for diarrhea other than, or in addition to, cryptosporidiosis.
  • Inability to receive oral medication.

Concurrent Medication:

Excluded:

  • Cancer chemotherapy (including therapy for Kaposi's sarcoma).
  • Any drug or biologic preparation (e.g., bovine colostrum, paromomycin, spiramycin, somatostatin) with possible anticryptosporidial activity.
  • Immunostimulant or lymphocyte replacement therapy.

Prior Medication:

Excluded:

  • Another investigational drug within 7 days prior to study enrollment (investigational medications available through a treatment IND will be allowed with the approval of the sponsor, the treatment IND sponsor, and the Pfizer clinical monitor).
  • Immunostimulant or lymphocyte replacement therapy.
  • Cancer chemotherapy (including therapy for Kaposi's sarcoma).

Not expected to comply with the requirements of the protocol, in the opinion of the investigator.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 NCT00002082
Other Study ID Numbers  ICMJE 058F
066-143
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS AccountNIH AIDS Clinical Trials Information Service
Verification DateApril 1996

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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