A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo

Sponsor

Pharmacia (Industry)

Overall Status

Completed

CT.gov ID

NCT00002101

Collaborator

(none)

450

Enrollment

Locations

10.2

Patients Per Site

Study Details

Study Description

Brief Summary

To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.

Condition or Disease	Intervention/Treatment	Phase
Mycobacterium Avium-Intracellulare Infection HIV Infections	Drug: Ethambutol hydrochloride Drug: Clarithromycin Drug: Rifabutin	Phase 3

Detailed Description

Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Concurrent Medication:

Allowed:

Isoniazid for TB prophylaxis ONLY.

Patients must have:

HIV infection.
MAC infection.
Life expectancy of at least 16 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Perceived unreliability or unavailability for frequent monitoring.

Concurrent Medication:

Excluded:

Antimycobacterial drugs other than the study drugs.
Carbamazepine.
Terfenadine.
Theophylline.

Patients with the following prior condition are excluded:

History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol.

Prior Medication:

Excluded within 7 days prior to study entry:

Rifabutin.
Rifampin.
Ethionamide.
Cycloserine.
Clofazimine.
Ethambutol.
Amikacin.
Ciprofloxacin.
Ofloxacin.
Sparfloxacin.
Azithromycin.
Clarithromycin.
Pyrazinamide.

Excluded within 14 days prior to study entry:

Carbamazepine.
Terfenadine.
Theophylline.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McDowell Clinic	Phoenix	Arizona	United States	85006
2	Maricopa Med Research Foundation	Phoenix	Arizona	United States	85008
3	Bay Harbor Hosp	Harbor City	California	United States	90710
4	Ctr for Special Immunology	Irvine	California	United States	92718
5	Combat Group	Los Angeles	California	United States	90028
6	Cedars Sinai Med Ctr	Los Angeles	California	United States	90048
7	Highland Gen Hosp / San Francisco Gen Hosp	Oakland	California	United States	946021018
8	HIV Research Group	San Diego	California	United States	92102
9	UCSD / Ctr for Special Immunology	San Diego	California	United States	92103
10	Saint Francis Mem Hosp	San Francisco	California	United States	94109
11	San Francisco Veterans Administration Med Ctr	San Francisco	California	United States	94121
12	Sunnyvale Med Clinic	Sunnyvale	California	United States	94086
13	George Washington Univ Med Ctr	Washington	District of Columbia	United States	20037
14	Veterans Administration Med Ctr	Washington	District of Columbia	United States	20422
15	Infectious Disease Consultants	Altamonte Springs	Florida	United States	32701
16	TheraFirst Med Ctrs Inc	Fort Lauderdale	Florida	United States	33308
17	Dr Frank Tornaka	Fort Lauderdale	Florida	United States	33316
18	Gary Richmond MD	Fort Lauderdale	Florida	United States	33316
19	Dr Nelson Zide	Hollywood	Florida	United States	33021
20	Ctr for Special Immunology	Miami Beach	Florida	United States	33140
21	Dr Barry Rodwick	Safety Harbor	Florida	United States	34695
22	Bay Area AIDS Consortium	Tampa	Florida	United States	33609
23	Infectious Disease Research Consortium of Georgia	Atlanta	Georgia	United States	30345
24	Dr Daniel Berger	Chicago	Illinois	United States	60657
25	Univ of Kansas School of Medicine	Wichita	Kansas	United States	67214
26	Tulane Univ Med School	New Orleans	Louisiana	United States	701122699
27	Dr Arnold Markowitz	Keego Harbor	Michigan	United States	48320
28	Univ of Nebraska Med Ctr / HIV Clinic	Omaha	Nebraska	United States	681985130
29	East Orange Veterans Administration Med Ctr	East Orange	New Jersey	United States	07018
30	North Jersey Community Research Initiative	Newark	New Jersey	United States	071032842
31	Long Island Jewish Med Ctr	New Hyde Park	New York	United States	11042
32	Chelsea Village Med Ctr / Saint Vincent's Hosp	New York	New York	United States	10014
33	Community Health Network	Rochester	New York	United States	14620
34	Nalle Clinic	Charlotte	North Carolina	United States	28207
35	Polyclinic Med Ctr	Harrisburg	Pennsylvania	United States	17110
36	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania	United States	19107
37	Charleston Veterans Administration Med Ctr	Charleston	South Carolina	United States	294015799
38	Dr Alfred F Burnside Jr	Columbia	South Carolina	United States	29204
39	Central Texas Med Foundation	Austin	Texas	United States	78751
40	Houston Veterans Administration Med Ctr	Houston	Texas	United States	77030
41	Univ TX San Antonio Health Science Ctr	San Antonio	Texas	United States	78284
42	Infectious Disease Physicians Inc	Annandale	Virginia	United States	22203
43	Univ of Wisconsin School of Medicine	Madison	Wisconsin	United States	53792
44	Milwaukee County Med Complex	Milwaukee	Wisconsin	United States	53226