The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00002331

Collaborator

(none)

Locations

13.9

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mycobacterium Avium-intracellular Infection HIV Infections	Drug: Ethambutol hydrochloride Drug: Clarithromycin Drug: Clofazimine	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 1994

Actual Primary Completion Date :

Mar 1, 1995

Actual Study Completion Date :

Mar 1, 1995

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Med Ctr	Los Angeles	California	United States	90027
2	UCD Med Ctr	Sacramento	California	United States	95817
3	Kaiser Permanente Med Ctr	San Francisco	California	United States	94115
4	Santa Clara Valley Med Ctr	San Jose	California	United States	951282699
5	George Washington Univ Med Ctr	Washington	District of Columbia	United States	20037
6	Dr Margaret Fischel	Miami	Florida	United States	33136
7	Saint Joseph's Hosp / Infectious Disease Rsch Institute	Tampa	Florida	United States	33614
8	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
9	Tulane Univ Med School	New Orleans	Louisiana	United States	701122699
10	Johns Hopkins Univ School of Medicine	Baltimore	Maryland	United States	21205
11	Beth Israel Med Ctr	New York	New York	United States	10003
12	Mount Sinai Med Ctr	New York	New York	United States	10029
13	Univ of North Carolina School of Medicine	Chapel Hill	North Carolina	United States	275997215
14	Dr Stephen Hauptman	Philadelphia	Pennsylvania	United States	19107
15	Vanderbilt Univ School of Medicine	Nashville	Tennessee	United States	37212
16	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas	United States	75235
17	Houston Veterans Administration Med Ctr	Houston	Texas	United States	77030
18	Dr Javier Morales	Condado San Juan		Puerto Rico	00907