A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients With AIDS

Completed · Phase 2

Conditions studied: Mycobacterium Avium-intracellulare Infection, HIV Infections

In brief

To compare the efficacy and safety of clarithromycin combined with rifabutin, ethambutol, or both in the treatment of disseminated Mycobacterium avium Complex (MAC) disease in persons with AIDS, including individuals who have or have not received prior MAC prophylaxis. 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.

Key facts

Study ID: NCT00001058
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 246
Expected to finish: 1999-01-01
Last updated by the study team: 2021-11-01

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Alabama Therapeutics CRS — Birmingham, Alabama, United States
USC CRS — Los Angeles, California, United States
UCLA CARE Center CRS — Los Angeles, California, United States
Ucsd, Avrc Crs — San Diego, California, United States
Ucsf Aids Crs — San Francisco, California, United States
Harbor-UCLA Med. Ctr. CRS — Torrance, California, United States
University of Colorado Hospital CRS — Aurora, Colorado, United States
The Ponce de Leon Ctr. CRS — Atlanta, Georgia, United States
Queens Med. Ctr. — Honolulu, Hawaii, United States
Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
Northwestern University CRS — Chicago, Illinois, United States
Cook County Hosp. CORE Ctr. — Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
Weiss Memorial Hosp. — Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
Indiana Univ. School of Medicine, Wishard Memorial — Indianapolis, Indiana, United States
Methodist Hosp. of Indiana — Indianapolis, Indiana, United States
Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
Bmc Actg Crs — Boston, Massachusetts, United States
Beth Israel Deaconess - East Campus A0102 CRS — Boston, Massachusetts, United States
Hennepin County Med. Ctr., Div. of Infectious Diseases — Minneapolis, Minnesota, United States
University of Minnesota, ACTU — Minneapolis, Minnesota, United States
Washington U CRS — St Louis, Missouri, United States
St. Louis ConnectCare, Infectious Diseases Clinic — St Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr. — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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