Completed

A Phase II/III Prospective, Multicenter, Randomized, Controlled Trial Comparing the Safety and Efficacy of Three Clarithromycin-Containing Combination Drug Regimens for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Disease in Persons With AIDS

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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections+20

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS. Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine, rifamycin derivatives, ethambutol, or the 4-quinolones. Patients are randomized to one of three treatment arms containing clarithromycin in combination with ethambutol, rifabutin, or both. Clarithromycin alone is taken on days 1 through 3 to determine tolerance and rifabutin and/or ethambutol is added on day 3. AS PER AMENDMENT 7/2/97: Patients may elect to add ritonavir or indinavir to their treatment regimen. Treatment continues daily for 48 weeks. In the absence of a dose-limiting toxicity, those patients who are determined to be complete or partial responders continue on the regimen to which they were originally assigned. Patients who have failed or relapsed on originally assigned MAC therapy, must have their therapy amended to receive clarithromycin and at least two other drugs not included in their originally assigned regimen. Patients are followed twice in the first week, then every 2 weeks for the first 2 months, then monthly for the next 4 months, and then every 2 months thereafter until the end of 12 months. PER AMENDMENT 10/10/96: NOTE: Any patient who develops a toxicity to rifabutin or ethambutol after week 12 or thereafter will be offered the option of being registered to a salvage regimen of 2 new drugs not previously received, plus clarithromycin to continue for the study duration.

Official TitleA Phase II/III Prospective, Multicenter, Randomized, Controlled Trial Comparing the Safety and Efficacy of Three Clarithromycin-Containing Combination Drug Regimens for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Disease in Persons With AIDS
NCT00001058
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

246 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeActinomycetales InfectionsBacterial Infections and MycosesBacterial InfectionsCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMycobacterium InfectionsMycobacterium Infections, NontuberculousRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralMycobacterium avium-intracellulare InfectionHIV InfectionsLentivirus InfectionsGram-Positive Bacterial Infections

Criteria

Inclusion Criteria Concurrent Medication: Allowed: * Antiretroviral therapy. * Maintenance or prophylactic therapy for other opportunistic infections (with the exception of specifically excluded drugs). * Carbamazepine or theophylline. * Isoniazid for TB prophylaxis. PER AMENDMENT 10/10/96: * Therapy for acute infectious processes, other than MAC, provided that the patient is stable on the therapy. * Fluconazole therapy for maintenance or suppression of fungal infections, providing the patient has been on a stable dose for at least 4 weeks. PER AMENDMENT 7/02/97: * If a patient elects to receive indinavir, ORTHO/NOVUM 1/35 is an acceptable means of birth control. Patients must have: * HIV infection. * Disseminated MAC disease. * Life expectancy of at least 8 weeks. * Consent of parent or guardian if under 18 years of age. NOTE: * This protocol is approved for prisoner participation. Prior Medication: Allowed: PER AMENDMENT 10/10/96: * Therapy for acute infectious processes, other than MAC, prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Active mycobacterial infection other than MAC that requires treatment, with the exception of isoniazid used solely for TB prophylaxis. Concurrent Medication: Excluded: * Other antimycobacterial drugs (with the exception of isoniazid for TB prophylaxis). * Other investigational drugs unless approved by protocol chair. PER AMENDMENT 7/2/97: * For patients who elect to receive indinavir or ritonavir: * Terfenadine, astemizole, cisapride, triazolam, or midazolam. * For patients who elect to receive ritonavir: * alprazolam, amiodarone, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam, dihydroergotamine, ergotamine, estazolam, encainide, flecainide, flurazepam, meperidine, pimozide, piroxicam, propafenone, propoxyphene, quinidine or zolpidem. * For patients who elect to receive indinavir: * oral contraceptives other than ORTHO/NOVUM as a sole form of birth control. * For patients randomized to a rifabutin-containing arm: * oral contraceptives or Norplant as a sole form of birth control. Patients with the following prior condition are excluded: * History of severe hypersensitivity to erythromycin, clarithromycin, azithromycin, ethambutol, rifampin, or rifabutin (including Type 1 hypersensitivity reaction, Stevens-Johnson syndrome, hepatitis, optic neuritis, or exfoliative dermatitis). Prior Medication: Excluded: * Empiric or presumptive antimycobacterial therapy prior to study entry if \> 14 days, within 90 days prior to entry. NOTE: * Patients unwilling to discontinue presumptive therapy or empiric therapy may be enrolled with the permission of the protocol chairs, however, if they are without a MAC positive blood culture at baseline, they will have study medications discontinued (AS PER AMENDMENT 7/2/97). PER AMENDMENT 10/10/96: * Treatment with clarithromycin or ethambutol within 4 days of initiation of study medications. * Treatment with rifabutin or rifampin within 7 days of initiation of study medications.

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 34 locations

Suspended

Alabama Therapeutics CRS

Birmingham, United StatesOpen Alabama Therapeutics CRS in Google Maps
Suspended

USC CRS

Los Angeles, United States
Suspended

UCLA CARE Center CRS

Los Angeles, United States
Suspended

Ucsd, Avrc Crs

San Diego, United States
Completed34 Study Centers