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

June 23, 2005 updated by: Rhone-Poulenc Rorer

Single-Blind Efficacy Evaluation of Intravenous Spiramycin in Subjects With AIDS-Related Cryptosporidial Diarrhea

To determine the safety and effectiveness of intravenous spiramycin in patients with AIDS-related cryptosporidial diarrhea.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 baseline conditions. They are informed that the treatment period is 21 days during which they receive 15 days of spiramycin and 6 consecutive days of placebo; they are not told which 6-day period they receive placebo. All patients receive 15 days of spiramycin. Patients who do not have a favorable response are treated with a higher dose of spiramycin for an additional 15 days. Responders at either dose are followed weekly for 4 weeks. Should a relapse occur, patients receive an additional 15 days of therapy, at the dose of spiramycin that initially produced a response, following reestablishment of a baseline with 6 days of placebo. Nonresponders to the higher dose are taken off the study.

Study Type

Interventional

Enrollment

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92120
        • Kaiser Permanente Med Ctr
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Univ School of Medicine
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Univ of Massachusetts Med Ctr
    • New York
      • New York, New York, United States, 10021
        • Cornell Univ Med Ctr
      • New York, New York, United States, 10016
        • Bellevue Hosp / New York Univ Med Ctr
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Univ Hosp of Cleveland / Case Western Reserve Univ
    • Texas
      • Dallas, Texas, United States, 75219
        • Nelson Tebedo Community Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhone-Poulenc Rorer

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: R Soave

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

October 1, 1990

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 113
  • FDA 28A
  • CCB-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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