Search / Trial NCT00000980

A Study of Spiramycin in the Treatment of Patients With AIDS-Related Diarrhea

Launched by RHONE-POULENC RORER · Aug 30, 2001

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Trial Information

Current as of November 28, 2023

Completed

Keywords

Single Blind Method Spiramycin Aids Related Opportunistic Infections Injections, Intravenous Cryptosporidiosis Diarrhea Drug Evaluation Acquired Immunodeficiency Syndrome

Description

Spiramycin, a macrolide antibiotic, has been studied in the United States for the treatment of cryptosporidial diarrhea. Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients. Results of one study, however, showed no significant difference between spiramycin and placebo (inactive medication). A later study indicated that the absorption of spiramycin is significantly decreased when food is present. Thus, the results of the trial may have been due to poor absorption of spiramycin. Patients are observed for 3 days to establish ba...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Vitamin supplements.
  • Zidovudine (AZT) for patients previously taking AZT. However, dosing with spiramycin should be delayed until the dose of AZT has stabilized. The dose may be decreased for AZT-associated toxicity.
  • Allowed for diarrhea:
  • Loperamide hydrochloride capsules (2 mg) or loperamide hydrochloride liquid (1 mg/5 ml).
  • Allowed for nausea:
  • Sucralfate and metoclopramide hydrochloride.
  • Allowed for vomiting:
  • Prochlorperazine and trimethobenzamide hydrochloride.
  • Allowed as prophylaxis for Pneumocystis carinii pneumonia (PCP):
  • Aerosolized pentamidine.
  • Patients must have:
  • A diagnosis of AIDS according to the CDC.
  • Chronic diarrhea.
  • Presence of Cryptosporidium oocysts in stool specimen. Patients or a legally authorized representative must sign an informed consent form. Diet will be lactose free, maximum 7 g fat/day with unlimited calorie intake. Patients who require total parenteral nutrition will also be allowed oral intake.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following are excluded:
  • Grade 4 (for hematologic) or Grade 3 (for all other) toxicity.
  • Known sensitivity to macrolide antibiotics.
  • Presence of other diarrhea-causing pathogens.
  • Active opportunistic infection requiring systemic antimicrobial therapy.
  • Toxicity grades according to NIAID toxicity scale for adults.
  • Concurrent Medication:
  • Excluded:
  • Other investigational drugs.
  • Cancer chemotherapy.
  • Alpha interferon.
  • Other immunomodulating agents.
  • Other macrolide antibiotics.
  • Trimethoprim / sulfamethoxazole.
  • Ganciclovir.
  • H2 blockers and AL-721.
  • Medications known to cause gastrointestinal irritation or alteration of gastrointestinal motility or absorption should be avoided if possible.
  • Zidovudine (AZT) therapy may not be initiated and the dose may not be increased during the study.
  • Patients with the following are excluded:
  • Grade 4 (for hematologic) or Grade 3 (for all other) toxicity.
  • Known sensitivity to macrolide antibiotics.
  • Presence of other diarrhea-causing pathogens.
  • Active opportunistic infection requiring systemic antimicrobial therapy.
  • Toxicity grades according to NIAID toxicity scale for adults.
  • Prior Medication:
  • Excluded within 7 days of study entry:
  • Investigational drugs.
  • Excluded within 14 days of study entry:
  • Cancer chemotherapy.
  • Alpha interferon.
  • Other immunomodulating agents.
  • Other macrolide antibiotics.
  • Trimethoprim / sulfamethoxazole.
  • Ganciclovir.

Attachments

readout_NCT00000980_2023-11-28.pdf

4.5 MB

NCT00000980_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

New York, New York, United States

Worcester, Massachusetts, United States

New York, New York, United States

Baltimore, Maryland, United States

Cleveland, Ohio, United States

San Diego, California, United States

Dallas, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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