Clinical trial NCT00002331: The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS
Official title: A Randomized Open-Label Study of the Tolerability and Efficacy of Clarithromycin and Ethambutol in Combination With or Without Clofazimine for the Treatment of Disseminated MAC (dMAC) in Patients With AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mycobacterium Avium-intracellular Infection
HIV Infections
Keywords: Mycobacterium avium-intracellular Infection
Drug Therapy, Combination
Ethambutol
Clofazimine
Acquired Immunodeficiency Syndrome
Clarithromycin
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente Med Ctr
state: California
city: Sacramento
country: United States
facility: UCD Med Ctr
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: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Miami
country: United States
facility: Dr Margaret Fischel
state: Florida
city: Tampa
country: United States
facility: Saint Joseph's Hosp / Infectious Disease Rsch Institute
state: Florida
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: New Orleans
country: United States
facility: Tulane Univ Med School
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Univ School of Medicine
state: Maryland
city: New York
country: United States
facility: Beth Israel Med Ctr
state: New York
city: New York
country: United States
facility: Mount Sinai Med Ctr
state: New York
city: Chapel Hill
country: United States
facility: Univ of North Carolina School of Medicine
state: North Carolina
city: Philadelphia
country: United States
facility: Dr Stephen Hauptman
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Univ School of Medicine
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: Condado San Juan
country: Puerto Rico
facility: Dr Javier Morales
Study officials:
References:
citation: Chaisson RE, Keiser P, Pierce M, Fessel WJ, Ruskin J, Lahart C, Benson CA, Meek K, Siepman N, Craft JC. Clarithromycin and ethambutol with or without clofazimine for the treatment of bacteremic Mycobacterium avium complex disease in patients with HIV infection. AIDS. 1997 Mar;11(3):311-7. doi: 10.1097/00002030-199703110-00008.