Study 9 of 19 for search of: "Cryptosporidiosis"
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
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.
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

MedlinePlus related topics: AIDS Cryptosporidiosis
Drug Information available for: Azithromycin
U.S. FDA Resources
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
  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

Study ID Numbers: 058F, 066-143
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002082  
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
Cryptosporidiosis
Digestive System Diseases
HIV Infections
Azithromycin
Sexually Transmitted Diseases
Parasitic Diseases
Intestinal Diseases, Parasitic
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Disease
Immune System Diseases
Coccidiosis
Infection
Pharmacologic Actions
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Syndrome
Lentivirus Infections
Protozoan Infections, Animal
Parasitic Diseases, Animal

ClinicalTrials.gov processed this record on January 16, 2009