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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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002082
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
  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: Endpoint Classification: Safety Study
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Infectious Disease Med Group
Oakland, California, United States, 94609
UCSD Med Ctr
San Diego, California, United States, 92103
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

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

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Cryptosporidiosis
HIV Infections
Syndrome
Coccidiosis
Digestive System Diseases
Disease
Gastrointestinal Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Intestinal Diseases
Intestinal Diseases, Parasitic
Lentivirus Infections
Parasitic Diseases
Parasitic Diseases, Animal
Pathologic Processes
Protozoan Infections
Protozoan Infections, Animal
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 19, 2014