A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS

Sponsor

Pharmacia (Industry)

Overall Status

Completed

CT.gov ID

NCT00001995

Collaborator

(none)

200

Enrollment

Locations

9.1

Patients Per Site

Study Details

Study Description

Brief Summary

To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.

Condition or Disease	Intervention/Treatment	Phase
Mycobacterium Avium-Intracellulare Infection HIV Infections	Drug: Rifabutin	N/A

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Concurrent Medication:

Allowed:

Zidovudine (AZT).
Didanosine (ddI).

Patients must have the following:

Diagnosis of AIDS as defined by the CDC.
Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB).
Provide written informed consent.

Prior Medication:

Allowed:

If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry.
Required:
Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Known hypersensitivity to any of the study drugs.

Concurrent Medication:

Excluded:

Other therapy for mycobacterial disease.

Patients with the following are excluded:

Known hypersensitivity to any of the study drugs.

Prior Medication:

Excluded within 4 weeks:

Therapy for mycobacterial disease.
Antiretroviral drugs, other than zidovudine (AZT) or ddI.
Investigational drugs, other than ddI.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maricopa County Med Ctr	Phoenix	Arizona	United States	85010
2	Bay Harbor Hosp	Harbor City	California	United States	90710
3	Ctr for Special Immunology	Irvine	California	United States	92718
4	Southwest Community Based AIDS Treatment Group - COMBAT	Los Angeles	California	United States	90028
5	AIDS Community Research Consortium	Redwood City	California	United States	94063
6	HIV Research Group	San Diego	California	United States	92102
7	Davies Med Ctr	San Francisco	California	United States	94114
8	San Francisco Veterans Administration Med Ctr	San Francisco	California	United States	94121
9	Veterans Administration Med Ctr	Washington	District of Columbia	United States	20422
10	TheraFirst Med Ctrs Inc	Fort Lauderdale	Florida	United States	33308
11	Ctr for Special Immunology	Fort Lauderdale	Florida	United States	33316
12	Mem Hosp Hollywood	Hollywood	Florida	United States	33021
13	Miami Veterans Administration Med Ctr	Miami	Florida	United States	33125
14	Infectious Disease Research Consortium of Georgia	Atlanta	Georgia	United States	30076
15	Dr Frank Rhame	Minneapolis	Minnesota	United States	55455
16	Research Med Ctr	Kansas City	Missouri	United States	64132
17	North Jersey Community Research Initiative	Newark	New Jersey	United States	071032842
18	Nassau County Med Ctr	East Meadow	New York	United States	11554
19	Chelsea Village Med Ctr / Saint Vincent's Hosp	New York	New York	United States	10014
20	Dr Alfred F Burnside Jr	Columbia	South Carolina	United States	29204
21	Infectious Disease Physicians Inc	Annandale	Virginia	United States	22203
22	Milwaukee County Med Complex	Milwaukee	Wisconsin	United States	53226