Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cryptosporidiosis; HIV Infections
Intervention: Azithromycin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pfizer
Summary
To evaluate the safety and efficacy of azithromycin in the treatment of intestinal
cryptosporidial infection in AIDS patients.
Clinical Details
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
Study design: Treatment, Double-Blind, Safety Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
UCSD Med Ctr, San Diego, California 92103, United States
Infectious Disease Med Group, Oakland, California 94609, United States
Cornell Univ Med Ctr, New York, New York 10021, United States
Univ of Tennessee, Memphis, Tennessee 38103, United States
Additional Information
Last updated: June 23, 2005
|
