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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002082
• Other study ID #: 058F
• Secondary ID: 066-143
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cryptosporidiosis
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Azithromycin

Locations

Country	Name	City	State
United States	Univ of Tennessee	Memphis	Tennessee
United States	Cornell Univ Med Ctr	New York	New York
United States	Infectious Disease Med Group	Oakland	California
United States	UCSD Med Ctr	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States,