Spiramycin Treatment for AIDS-Related Cryptosporidial Diarrhea
Data Collection
Blood-Borne Infections+30
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
This study is about evaluating the effectiveness of a drug called Spiramycin in treating diarrhea caused by a parasite called Cryptosporidium in patients with AIDS. Some studies suggest that Spiramycin can help improve symptoms, but other results show no significant difference between Spiramycin and a placebo (a substance with no therapeutic effect). This research aims to clarify these mixed results, considering that the absorption of Spiramycin may be decreased when food is present, which could have affected previous trial outcomes. The study is important as it could potentially provide a new treatment option for AIDS-related Cryptosporidial diarrhea, a condition that currently lacks effective therapies. Participants in this study are first observed for 3 days to establish their initial condition. They are then given Spiramycin for 15 days and a placebo for 6 days, without being informed about which period they receive the placebo. All participants receive Spiramycin for 15 days. If a patient does not respond favorably, they receive a higher dose of Spiramycin for an additional 15 days. Those who respond positively to either dose are monitored weekly for 4 weeks. If a relapse occurs, patients receive an additional 15 days of therapy at the Spiramycin dose that initially produced a response, following reestablishment of a baseline with 6 days of placebo. Participants who do not respond to the higher dose are removed from the study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Johns Hopkins Univ School of Medicine
Baltimore, United StatesUniv of Massachusetts Med Ctr
Worcester, United StatesBellevue Hosp / New York Univ Med Ctr
New York, United States