To determine whether clarithromycin is safe and effective in preventing disseminated Mycobacterium avium Complex in HIV-infected patients with CD4 counts <= 100 cells/mm3.

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

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must have:

• HIV infection.
• CD4 count <= 100 cells/mm3.
• No evidence of MAC.
• Life expectancy of at least 6 months.

Exclusion Criteria

Concurrent Medication: Excluded:

• Certain restricted drugs (details not available). Patients with the following prior conditions are excluded: History of allergy or hypersensitivity to macrolides. Active substance abuse or other conditions that would affect study compliance.

Arizona
      Univ of Arizona / Health Science Ctr, Tucson,  Arizona,  85724,  United States
California
      HIV Research Group, San Diego,  California,  92102,  United States
      Saint Francis Mem Hosp, San Francisco,  California,  94109,  United States
      Santa Clara Valley Med Ctr, San Jose,  California,  951282699,  United States
      California Med Research Group, Fresno,  California,  93726,  United States
      Kaiser Permanente Med Ctr, San Francisco,  California,  94115,  United States
Florida
      TheraFirst Med Ctrs Inc, Fort Lauderdale,  Florida,  33308,  United States
      Dr Nelson Zide, Hollywood,  Florida,  33021,  United States
      Infectious Disease Research Institute Inc, Tampa,  Florida,  33614,  United States
Indiana
      Indiana Univ Hosp, Indianapolis,  Indiana,  46202,  United States
New York
      New York Med College / Westchester County Med Ctr, Valhalla,  New York,  10595,  United States
      Saint Vincent's Hosp and Med Ctr, New York,  New York,  10011,  United States
      SUNY / Health Sciences Ctr at Syracuse, Syracuse,  New York,  13210,  United States
North Carolina
      Nalle Clinic, Charlotte,  North Carolina,  28207,  United States
Oregon
      Westover Heights Clinic, Portland,  Oregon,  97210,  United States
Tennessee
      Vanderbilt Univ, Nashville,  Tennessee,  37212,  United States
      Univ of Tennessee, Memphis,  Tennessee,  38163,  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
      Audie L Murphy Veterans Administration Hosp, San Antonio,  Texas,  78284,  United States
Virginia
      Salem Veterans Administration Med Ctr, Salem,  Virginia,  24153,  United States
Washington
      Dr Alan D Tice / Infections Ltd, Tacoma,  Washington,  98405,  United States

Study ID Numbers:  124A; M91-561
Record last reviewed:  May 1994
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002336
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08