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Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Pfizer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002082
  Purpose

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


Condition Intervention
Cryptosporidiosis
HIV Infections
Drug: Azithromycin

Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
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

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002082

Locations
United States, California
UCSD Med Ctr
San Diego, California, United States, 92103
Infectious Disease Med Group
Oakland, California, United States, 94609
United States, New York
Cornell Univ Med Ctr
New York, New York, United States, 10021
United States, Tennessee
Univ of Tennessee
Memphis, Tennessee, United States, 38103
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

Study ID Numbers: 058F, 066-143
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002082     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Cryptosporidiosis
Acquired Immunodeficiency Syndrome
Azithromycin

Study placed in the following topic categories:
Protozoan Infections
Sexually Transmitted Diseases, Viral
Gastrointestinal Diseases
Acquired Immunodeficiency Syndrome
Intestinal Diseases
Immunologic Deficiency Syndromes
Virus Diseases
Anti-Bacterial Agents
Cryptosporidiosis
Digestive System Diseases
HIV Infections
Azithromycin
Sexually Transmitted Diseases
Parasitic Diseases
Intestinal Diseases, Parasitic
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Gastrointestinal Diseases
Infection
Anti-Bacterial Agents
Cryptosporidiosis
Pathologic Processes
Therapeutic Uses
Azithromycin
Syndrome
Parasitic Diseases
Parasitic Diseases, Animal
Retroviridae Infections
Protozoan Infections
RNA Virus Infections
Disease
Immune System Diseases
Coccidiosis
Acquired Immunodeficiency Syndrome
Intestinal Diseases
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Protozoan Infections, Animal
Intestinal Diseases, Parasitic

ClinicalTrials.gov processed this record on July 02, 2009