- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000644
A Phase II Safety and Efficacy Study of Clarithromycin in the Treatment of Disseminated M. Avium Complex (MAC) Infections in Patients With AIDS
This study is designed to evaluate the efficacy and safety of clarithromycin given orally at 1 of 3 doses to treat disseminated Mycobacterium avium complex infections (MAC) in patients with AIDS.
Mycobacterium avium complex (MAC) is thought to be the most common disseminated bacterial opportunistic infection in AIDS, with clinical prevalence estimates ranging from 15 to 50 percent of all AIDS patients. Clarithromycin, a new macrolide antimicrobial agent, has demonstrated activity against MAC both in the laboratory and in animals. Clinical experience treating AIDS patients with clarithromycin for disseminated MAC is limited. However, early studies have indicated few adverse effects and some improvement in clinical symptoms scores and Karnofsky performance scores over placebo treated patients.
Study Overview
Status
Intervention / Treatment
Detailed Description
Mycobacterium avium complex (MAC) is thought to be the most common disseminated bacterial opportunistic infection in AIDS, with clinical prevalence estimates ranging from 15 to 50 percent of all AIDS patients. Clarithromycin, a new macrolide antimicrobial agent, has demonstrated activity against MAC both in the laboratory and in animals. Clinical experience treating AIDS patients with clarithromycin for disseminated MAC is limited. However, early studies have indicated few adverse effects and some improvement in clinical symptoms scores and Karnofsky performance scores over placebo treated patients.
Treatment is randomly assigned so that twice as many patients receive clarithromycin at the lower dose as at an intermediate dose for 12 weeks. Once data becomes available to support dosing patients with clarithromycin at the highest dose, then treatment will be randomly assigned so that twice as many patients receive clarithromycin at the highest dose as at the intermediate dose. Sixteen patients per group (48 patients in all) will be enrolled. Patients exhibiting clinical improvement or clinical cure while on this trial will be allowed to continue on therapy for an additional 6 months. Patients will have clinical evaluations (including the Karnofsky Performance Scale), laboratory evaluations (hematology and chemistry), and blood cultures for MAC performed monthly.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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California
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Los Angeles, California, United States, 900331079
- Univ of Southern California / LA County USC Med Ctr
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
-
-
Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hosp
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
Allowed:
- Didanosine (ddI).
- Dideoxycytidine (ddC).
- Zidovudine (AZT).
- Acetaminophen.
- Acyclovir.
- Fluconazole.
- Erythropoietin (EPO).
- Systemic Pneumocystis carinii pneumonia (PCP) prophylaxis (aerosolized or oral pentamidine, trimethoprim / sulfamethoxazole, or dapsone).
- Maintenance ganciclovir therapy (permitted only if dose and clinical and laboratory parameters have been stable for at least 4 weeks prior to study entry).
- Maintenance treatment for other opportunistic infections if the dose and clinical and laboratory parameters have been stable for 4 weeks prior to study entry.
Patients must have:
- Positive results for HIV by ELISA confirmed by another method.
- Positive blood culture for Mycobacterium avium complex within 2 months of study entry and clinical symptoms of MAC infection.
- Discontinued all mycobacterial drugs (approved and investigational) for at least 4 weeks prior to the start of drug therapy (with the exception of isoniazid prophylaxis which should be discontinued at Study Day minus 14 to Study Day minus 7
- Given written informed consent to participate in the trial.
- Met the listed laboratory parameters in the pre-treatment visit.
Prior Medication:
Allowed:
- Didanosine (ddI).
- Deoxycytidine (ddC).
- Zidovudine (AZT).
- Acetaminophen.
- Acyclovir.
- Fluconazole.
- Erythropoietin (EPO).
- Systemic Pneumocystis carinii pneumonia (PCP) prophylaxis (aerosolized or oral pentamidine, dapsone, trimethoprim / sulfamethoxazole).
- Maintenance ganciclovir therapy (permitted only if dose and clinical and laboratory parameters have been stable for at least 4 weeks prior to study entry).
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Active opportunistic infections. Maintenance treatment for other opportunistic infections will be permitted if the dose and clinical and laboratory parameters have been stable for 4 weeks prior to study entry.
Concurrent Medication:
Excluded:
- Aminoglycosides.
- Ansamycin (rifabutin).
- Quinolones.
- Other macrolides.
- Clofazimine.
- Cytotoxic chemotherapy.
- Rifampin.
- Ethambutol.
- Immunomodulators (except alpha interferon).
- Investigational drugs (except ddI, ddC, and erythropoietin).
Patients with the following are excluded:
- History of allergy to macrolide antimicrobials.
- Currently on active therapy with any anti-mycobacterial drugs listed in Exclusion Prior Medications.
- Currently on active therapy with carbamazepine or theophylline, unless the investigator agrees to carefully monitor blood levels.
- Inability to comply with the protocol or judged to be near imminent death by the investigator.
- Active opportunistic infections.
- Requiring any of the excluded concomitant medications.
Prior Medication:
Excluded for at least 4 weeks prior to study entry:
- All anti-mycobacterial drugs (approved and investigational) with the exception of isoniazid prophylaxis, which should be discontinued at Study Day minus 14 to minus 7.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Chaisson RE, Benson CA, Dube MP, Heifets LB, Korvick JA, Elkin S, Smith T, Craft JC, Sattler FR. Clarithromycin therapy for bacteremic Mycobacterium avium complex disease. A randomized, double-blind, dose-ranging study in patients with AIDS. AIDS Clinical Trials Group Protocol 157 Study Team. Ann Intern Med. 1994 Dec 15;121(12):905-11. doi: 10.7326/0003-4819-121-12-199412150-00001.
- Wu AW, Lichter SL, Richardson W, Urbanski PA, Benson C, Sattler FR, Chaisson R. Quality of life in patients receiving clarithromycin for Mycobacterium avium complex infection and AIDS. Int Conf AIDS. 1992 Jul 19-24;8(2):B178 (abstract no PoB 3550)
- Chaisson RE, Benson CA, Dube M, Hafner R, Dellerson M, Lichter S, Smith T, Sattler FR. Clarithromycin for disseminated Mycobacterium avium-complex in AIDS patients. Int Conf AIDS. 1992 Jul 19-24;8(1):We54 (abstract no WeB 1052)
Study record dates
Study Major Dates
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections, Nontuberculous
- Infections
- Communicable Diseases
- Mycobacterium Infections
- Mycobacterium avium-intracellulare Infection
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Clarithromycin
Other Study ID Numbers
- ACTG 157
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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