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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



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

For Condition: Cryptosporidiosis,HIV Infections
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: To evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Univ of Tennessee
Memphis,  Tennessee,  38103
United States
 

Cornell Univ Med Ctr
New York City,  New York,  10021
United States
 

Infectious Disease Med Group
Oakland,  California,  94609
United States
 

UCSD Med Ctr
San Diego,  California,  92103
United States
 


Additional Information:
Study ID Numbers:
  058F;  066-143
Study Start Date: 
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002082

Other Cryptosporidiosis Studies:
1. Promoting Adherence to Anti-HIV Drug Regimens

2. A Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients with AIDS Who Have Already Been Treated with Ganciclovir

3. The Effectiveness of HIV RNA Viral Load Testing in Determining Treatment Type in HIV-Infected Patients

4. A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Infants and Children Infected With or at Risk for HIV Infection

5. A Study of Pentamidine Plus Dapsone in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients Who Cannot Take Trimethoprim or Sulfonamides

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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

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