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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002082 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

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 Summary	To evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Safety Study
Condition ^ICMJE	Cryptosporidiosis HIV Infections
Intervention ^ICMJE	Drug: Azithromycin
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002082
Responsible Party
Study ID Numbers ^ICMJE	058F, 066-143
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	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