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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00002082

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cryptosporidiosis HIV Infections	Drug: Azithromycin	N/A

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Infectious Disease Med Group	Oakland	California	United States	94609
2	UCSD Med Ctr	San Diego	California	United States	92103
3	Cornell Univ Med Ctr	New York	New York	United States	10021
4	Univ of Tennessee	Memphis	Tennessee	United States	38103