Clinical trial NCT00002140: A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients
Official title: A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mycobacterium Avium-intracellulare Infection
HIV Infections
Keywords: Mycobacterium avium-intracellulare Infection
Drug Therapy, Combination
Ethambutol
Acquired Immunodeficiency Syndrome
Azithromycin
Clarithromycin
Lead sponsor: NIH AIDS Clinical Trials Information Service
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: 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..

Detailed description: 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.

Eligibility 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: East Bay AIDS Ctr
state: California
city: Mill Valley
country: United States
facility: Dr Milton Estes
state: California
city: Oakland
country: United States
facility: Infectious Disease Med Group / Adult Immunology Clinic
state: California
city: Orange
country: United States
facility: UCI 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: Groton
country: United States
facility: Pfizer Central Research
state: Connecticut
city: Washington
country: United States
facility: Georgetown Univ Med Ctr
state: District of Columbia
city: Washington
country: United States
facility: Whitman - Walker Clinic
state: District of Columbia
city: Miami
country: United States
facility: Med Service
state: Florida
city: St Petersburg
country: United States
facility: Dr Robert Wallace
state: Florida
city: Tampa
country: United States
facility: Bay Area AIDS Consortium
state: Florida
city: Atlanta
country: United States
facility: West Paces Clinical Research Inc
state: Georgia
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: Chicago
country: United States
facility: Dr Neel French / Louis A Weiss Memorial Hosp
state: Illinois
city: New Orleans
country: United States
facility: Oschner Clinic
state: Louisiana
city: Kansas City
country: United States
facility: Trinity Lutheran Hosp / Infectious Disease Clinic
state: Missouri
city: Durham
country: United States
facility: Duke Univ Med Ctr
state: North Carolina
city: Austin
country: United States
facility: Austin Infectious Disease Consultants
state: Texas
city: Austin
country: United States
facility: Central Texas Med Foundation
state: Texas
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Houston
country: United States
facility: Thomas Street Clinic / Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Dr Gary Brewton
state: Texas
city: Hampton
country: United States
facility: Hampton Roads Med Specialists
state: Virginia
Study officials:
References:
citation: Dunne M, Fessel J, Kumar P, Dickenson G, Keiser P, Boulos M, Mogyros M, White AC Jr, Cahn P, O'Connor M, Lewi D, Green S, Tilles J, Hicks C, Bissett J, Schneider MM, Benner R. A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus. Clin Infect Dis. 2000 Nov;31(5):1245-52. doi: 10.1086/317468. Epub 2000 Nov 6.