To evaluate the efficacy and safety of two different doses of azithromycin in combination with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC) infection, and to determine whether an azithromycin-containing regimen is at least as safe and effective as the same regimen containing clarithromycin..

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

Further Study Details: 

Patients are randomized to receive azithromycin at one of two doses in combination with ethambutol or clarithromycin in combination with ethambutol for 24 weeks, after which they are evaluated for entry into a maintenance phase of treatment. Clinical, microbiologic, and safety assessments are performed every 3 weeks for the first 12 weeks, then monthly for the remaining 12 weeks.

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

Criteria

Inclusion Criteria

Patients must have:

• HIV seropositivity.
• Disseminated MAC.
• No MAC therapy between time of last positive blood culture draw and study entry (single-agent prophylaxis allowed).
• Life expectancy of at least 2 months.
• Consent of parent or guardian if below legal age of consent.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded:

• Known hypersensitivity to macrolide antibiotics (erythromycin, azithromycin, or clarithromycin) or ethambutol.
• Inability to take oral medications.
• Condition likely to interfere with drug absorption (e.g., gastrectomy, malabsorption syndromes). Concurrent Medication: Excluded:
• Another investigational drug started in the week prior to study entry. Prior Medication: Excluded:
• MAC therapy between time of last positive blood culture draw and study entry (although single-agent prophylaxis is allowed).

California
      Infectious Disease Med Group / Adult Immunology Clinic, Oakland,  California,  94609,  United States
      Santa Clara Valley Med Ctr, San Jose,  California,  951282699,  United States
      UCI Med Ctr, Orange,  California,  92668,  United States
      East Bay AIDS Ctr, Berkeley,  California,  94705,  United States
      Kaiser Permanente Med Ctr, San Francisco,  California,  94115,  United States
      Dr Milton Estes, Mill Valley,  California,  94941,  United States
Connecticut
      Pfizer Central Research, Groton,  Connecticut,  06340,  United States
District of Columbia
      Whitman - Walker Clinic, Washington,  District of Columbia,  20009,  United States
      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States
Florida
      Med Service, Miami,  Florida,  33125,  United States
      Bay Area AIDS Consortium, Tampa,  Florida,  33609,  United States
      Dr Robert Wallace, St. Petersburg,  Florida,  33713,  United States
Georgia
      West Paces Clinical Research Inc, Atlanta,  Georgia,  30327,  United States
Illinois
      Northwestern Univ Med School, Chicago,  Illinois,  60611,  United States
      Dr Neel French / Louis A Weiss Memorial Hosp, Chicago,  Illinois,  60640,  United States
Louisiana
      Oschner Clinic, New Orleans,  Louisiana,  70121,  United States
Missouri
      Trinity Lutheran Hosp / Infectious Disease Clinic, Kansas City,  Missouri,  64108,  United States
North Carolina
      Duke Univ Med Ctr, Durham,  North Carolina,  27710,  United States
Texas
      Dr Gary Brewton, Houston,  Texas,  77027,  United States
      Univ of Texas Southwestern Med Ctr of Dallas, Dallas,  Texas,  75235,  United States
      Austin Infectious Disease Consultants, Austin,  Texas,  78705,  United States
      Thomas Street Clinic / Baylor College of Medicine, Houston,  Texas,  77009,  United States
      Central Texas Med Foundation, Austin,  Texas,  78751,  United States
Virginia
      Hampton Roads Med Specialists, Hampton,  Virginia,  23666,  United States

Study ID Numbers:  226B; 066-189; 189/189B
Record last reviewed:  July 1998
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002140
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08