Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study
NCT00002082
ABOUT THIS STUDY
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1-800-718-1021
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.
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.
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Descriptive Information | |||
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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 Summary | To evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Not Applicable | ||
Study Design ICMJE | Masking: Double Primary Purpose: Treatment | ||
Condition ICMJE |
| ||
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 Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
Patients must have:
Prior Medication: Allowed:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded:
Concurrent Medication: Excluded:
Prior Medication: Excluded:
Not expected to comply with the requirements of the protocol, in the opinion of the investigator. | ||
Sex/Gender ICMJE |
| ||
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 Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Pfizer | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | NIH AIDS Clinical Trials Information Service | ||
Verification Date | April 1996 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |