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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000980
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1990
  Purpose

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.


Condition Intervention Phase
Cryptosporidiosis
HIV Infections
Drug: Spiramycin
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Single-Blind Efficacy Evaluation of Intravenous Spiramycin in Subjects With AIDS-Related Cryptosporidial Diarrhea

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 25
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000980

Locations
United States, California
Kaiser Permanente Med Ctr
San Diego, California, United States, 92120
United States, Maryland
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States, 01655
United States, New York
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Cornell Univ Med Ctr
New York, New York, United States, 10021
United States, Ohio
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
United States, Texas
Nelson Tebedo Community Clinic
Dallas, Texas, United States, 75219
Sponsors and Collaborators
Rhone-Poulenc Rorer
Investigators
Study Chair: R Soave
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00000980     History of Changes
Other Study ID Numbers: ACTG 113, FDA 28A, CCB-301
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Single-Blind Method
Spiramycin
AIDS-Related Opportunistic Infections
Injections, Intravenous
Cryptosporidiosis
Diarrhea
Drug Evaluation
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Cryptosporidiosis
Diarrhea
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Intestinal Diseases, Parasitic
Parasitic Diseases
Protozoan Infections, Animal
Parasitic Diseases, Animal
Coccidiosis
Protozoan Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Spiramycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Coccidiostats

ClinicalTrials.gov processed this record on April 16, 2014