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A Study of Spiramycin in the Treatment of Patients with AIDS-Related Diarrhea Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Study of Spiramycin in the Treatment of Patients with AIDS-Related Diarrhea conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Study of Spiramycin in the Treatment of Patients with AIDS-Related Diarrhea Clinical research trials and A Study of Spiramycin in the Treatment of Patients with AIDS-Related Diarrhea health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Study of Spiramycin in the Treatment of Patients with AIDS-Related Diarrhea. A Study of Spiramycin in the Treatment of Patients with AIDS-Related Diarrhea Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study of Spiramycin in the Treatment of Patients with AIDS-Related Diarrhea clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Study of Spiramycin in the Treatment of Patients with AIDS-Related Diarrhea condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of Spiramycin in the Treatment of Patients with AIDS-Related Diarrhea  A Study of Spiramycin in the Treatment of Patients with AIDS-Related Diarrhea
A Study of Spiramycin in the Treatment of Patients with AIDS-Related Diarrhea
For Condition: Cryptosporidiosis,HIV Infections
Status: Completed
Sponsor(s): Rhone-Poulenc Rorer , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 25
Location and Contact Information:
Overall Study Official:
RSoave, Study Chair,
Kaiser Permanente Med Ctr
San Diego, California, 92120
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Nelson Tebedo Community Clinic
Dallas, Texas, 75219
United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21205
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Additional Information:
Study ID Numbers: ACTG 113; FDA 28A,CCB-301
Study Start Date:
Record last reviewed: October 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000980
Other Hiv Infections Studies:
1. Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
2. Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients
3. A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis (Diarrhea Caused by the Parasite Cryptosporidium)
4. A Study of Spiramycin in the Treatment of Patients with AIDS-Related Diarrhea
5. Protocol For the Treatment of Cryptosporidiosis in AIDS Patients with Diclazuril (R64,433)
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A Study of Spiramycin in the Treatment of Patients with AIDS-Related Diarrhea
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