A Study of Spiramycin in the Treatment of Patients With AIDS-Related Diarrhea
Single-Blind Efficacy Evaluation of Intravenous Spiramycin in Subjects With AIDS-Related Cryptosporidial Diarrhea
3 other identifiers
interventional
25
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
October 1, 1990
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +1 more criteria
You may not qualify if:
- 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.
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Kaiser Permanente Med Ctr
San Diego, California, 92120, United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21205, United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Nelson Tebedo Community Clinic
Dallas, Texas, 75219, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
R Soave
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1990-10