PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC). SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.

Condition	Treatment or Intervention
Mycobacterium avium-intracellulare Infection HIV Infections	Drug: Ethambutol hydrochloride  Drug: Clarithromycin  Drug: Clofazimine

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must have:

• History of HIV seropositivity.
• Disseminated MAC.
• Positive blood culture for MAC within 4 weeks prior to study entry.
• Consent of parent or guardian if less than 18 years of age.
• Ability to complete the study. NOTE:
• Patients with active opportunistic infections other than dMAC are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment.

Exclusion Criteria

Concurrent Medication: Excluded:

• Active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels.
• Active therapy with investigational drugs other than treatment for HIV disease, except with approval of the sponsor.
• Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal).
• Amikacin.
• Azithromycin.
• Capreomycin.
• Ciprofloxacin.
• Cycloserine.
• Ethionamide.
• Gentamicin.
• Kanamycin.
• Levofloxacin.
• Lomefloxacin.
• Ofloxacin.
• Rifampin.
• Rifabutin.
• Sparfloxacin.
• Streptomycin.
• Any other aminoglycosides, quinolones, and macrolides. Patients with the following prior conditions are excluded: History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine.

Prior Medication: Excluded:

• Other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry.
• Clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more than 14 days cumulative within the past 2 months.

California
      UCD Med Ctr, Sacramento,  California,  95817,  United States
      Santa Clara Valley Med Ctr, San Jose,  California,  951282699,  United States
      Kaiser Permanente Med Ctr, Los Angeles,  California,  90027,  United States
      Kaiser Permanente Med Ctr, San Francisco,  California,  94115,  United States
District of Columbia
      George Washington Univ Med Ctr, Washington,  District of Columbia,  20037,  United States
Florida
      Dr Margaret Fischel, Miami,  Florida,  33136,  United States
      Saint Joseph's Hosp / Infectious Disease Rsch Institute, Tampa,  Florida,  33614,  United States
Illinois
      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States
Louisiana
      Tulane Univ Med School, New Orleans,  Louisiana,  701122699,  United States
Maryland
      Johns Hopkins Univ School of Medicine, Baltimore,  Maryland,  21205,  United States
New York
      Beth Israel Med Ctr, New York,  New York,  10003,  United States
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States
North Carolina
      Univ of North Carolina School of Medicine, Chapel Hill,  North Carolina,  275997215,  United States
Pennsylvania
      Dr Stephen Hauptman, Philadelphia,  Pennsylvania,  19107,  United States
Tennessee
      Vanderbilt Univ School of Medicine, Nashville,  Tennessee,  37212,  United States
Texas
      Houston Veterans Administration Med Ctr, Houston,  Texas,  77030,  United States
      Univ of Texas Southwestern Med Ctr of Dallas, Dallas,  Texas,  75235,  United States
Puerto Rico
      Dr Javier Morales, Condado San Juan,  00907,  Puerto Rico

Study ID Numbers:  214A; M93-069
Record last reviewed:  March 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002331
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08