Clinical trial NCT00002336: The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
Official title: A Prospective, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Clarithromycin for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients With CD4 Counts <= 100 Cells/mm3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mycobacterium Avium-intracellular Infection
HIV Infections
Keywords: Mycobacterium avium-intracellular Infection
Acquired Immunodeficiency Syndrome
Clarithromycin
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Univ of Arizona / Health Science Ctr
state: Arizona
city: Fresno
country: United States
facility: California Med Research Group
state: California
city: San Diego
country: United States
facility: HIV Research Group
state: California
city: San Francisco
country: United States
facility: Saint Francis Mem Hosp
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Med Ctr
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Med Ctr
state: California
city: Fort Lauderdale
country: United States
facility: TheraFirst Med Ctrs Inc
state: Florida
city: Hollywood
country: United States
facility: Dr Nelson Zide
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Research Institute Inc
state: Florida
city: Indianapolis
country: United States
facility: Indiana Univ Hosp
state: Indiana
city: New York
country: United States
facility: Saint Vincent's Hosp and Med Ctr
state: New York
city: Syracuse
country: United States
facility: SUNY / Health Sciences Ctr at Syracuse
state: New York
city: Valhalla
country: United States
facility: New York Med College / Westchester County Med Ctr
state: New York
city: Charlotte
country: United States
facility: Nalle Clinic
state: North Carolina
city: Portland
country: United States
facility: Westover Heights Clinic
state: Oregon
city: Memphis
country: United States
facility: Univ of Tennessee
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Univ
state: Tennessee
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Houston
country: United States
facility: Houston Veterans Administration Med Ctr
state: Texas
city: San Antonio
country: United States
facility: Audie L Murphy Veterans Administration Hosp
state: Texas
city: Salem
country: United States
facility: Salem Veterans Administration Med Ctr
state: Virginia
city: Tacoma
country: United States
facility: Dr Alan D Tice / Infections Ltd
state: Washington
Study officials:
References:
citation: Pierce M, Crampton S, Henry D, Heifets L, LaMarca A, Montecalvo M, Wormser GP, Jablonowski H, Jemsek J, Cynamon M, Yangco BG, Notario G, Craft JC. A randomized trial of clarithromycin as prophylaxis against disseminated Mycobacterium avium complex infection in patients with advanced acquired immunodeficiency syndrome. N Engl J Med. 1996 Aug 8;335(6):384-91. doi: 10.1056/NEJM199608083350603.