Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial

Sponsor

Pharmacia (Industry)

Overall Status

Completed

CT.gov ID

NCT00002267

Collaborator

(none)

750

Enrollment

Locations

17.4

Patients Per Site

Study Details

Study Description

Brief Summary

The primary objective of this trial is to assess the safety and the relative benefit of rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200, as compared to placebo, and to assess if survival is prolonged in patients who receive rifabutin prophylaxis.

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:

Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial

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

Patients must have the following:

Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC).
Written informed consent obtained, which must include a statement that treatment may involve risks to the embryo or fetus, which are currently unforeseeable, if the subject becomes pregnant.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddI).
Previous or current infection due to Mycobacterium avium complex (MAC) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation.

Concurrent Medication:

Excluded:

Antiretroviral agents other than zidovudine (AZT).
Didanosine (ddI).
Antimycobacterial therapy.
Rifampin.
Isoniazid.
Clofazimine.
Ethambutol.
Cycloserine.
Ethionamide.
Amikacin.
Ciprofloxacin.
Streptomycin.
Other investigational drugs.
If antimicrobial therapy is required to treat bacterial infections (= or < 14 days), Adria Laboratories must be contacted prior to initiation of therapy.

Patients with the following are excluded:

Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine (AZT), or didanosine (ddI).
Previous or current Mycobacterium avium complex (MAC) infection.
Perceived patient unreliability or unavailability for frequent monitoring.

Prior Medication:

Excluded within 4 weeks of study entry:

Antiretroviral agents other than zidovudine (AZT) or didanosine (ddI).
Antimycobacterial therapy.
Rifampin.
Isoniazid.
Clofazimine.
Ethambutol.
Cycloserine.
Ethionamide.
Amikacin.
Ciprofloxacin.

Required:

Zidovudine (AZT).
Antipneumocystis prophylactic therapy.

Required for at least 4 weeks prior to study entry:

Zidovudine (AZT) or didanosine (ddI).
Antipneumocystis prophylaxis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maricopa County Med Ctr	Phoenix	Arizona	United States	85010
2	East Bay AIDS Ctr	Berkeley	California	United States	94704
3	Pacific Oaks Med Group	Beverly Hills	California	United States	90211
4	AIDS Community Research Consortium	Redwood City	California	United States	94063
5	HIV Research Group	San Diego	California	United States	92102
6	Dr Larry A Waites	San Francisco	California	United States	94108
7	Saint Francis Mem Hosp / HIV Care	San Francisco	California	United States	94109
8	Dr Marcus Conant	San Francisco	California	United States	94115
9	San Francisco Veterans Administration Med Ctr	San Francisco	California	United States	94121
10	Dr Marshall Kubota	Santa Rosa	California	United States	95404
11	Dr Jeffrey Galpin	Tarzana	California	United States	91356
12	Miami Veterans Administration Med Ctr	Miami	Florida	United States	33125
13	Community Research Initiative of South Florida	Miami	Florida	United States	33137
14	Northwestern Univ Med School	Chicago	Illinois	United States	60611
15	AIDS Research Alliance - Chicago	Chicago	Illinois	United States	60657
16	Tulane Univ School of Medicine	New Orleans	Louisiana	United States	70112
17	Comprehensive AIDS Alliance of Detroit / Harper Hosp	Detroit	Michigan	United States	48201
18	Univ of Minnesota	Minneapolis	Minnesota	United States	55455
19	St Paul Ramsey Med Ctr	St Paul	Minnesota	United States	55101
20	Univ of Nevada / Veterans Administration Med Ctr	Reno	Nevada	United States	89520
21	North Jersey Community Research Initiative	Newark	New Jersey	United States	071032842
22	Univ of New Mexico Hlth Sciences Ctr / Dept of Med	Albuquerque	New Mexico	United States	87131
23	Dr Donald Romig	Sante Fe	New Mexico	United States	87501
24	Albany Veterans Administration	Albany	New York	United States	12208
25	AIDS Services Erie County Med Ctr	Buffalo	New York	United States	14215
26	Community Health Network	Rochester	New York	United States	14620
27	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania	United States	19107
28	Thomas Jefferson Med College	Philadelphia	Pennsylvania	United States	19107
29	Dr Alfred F Burnside Jr	Columbia	South Carolina	United States	29204
30	Infectious Disease Physicians Inc	Annandale	Virginia	United States	22203
31	Milwaukee County Med Complex	Milwaukee	Wisconsin	United States	53226
32	Univ of Calgary Health Science Ctr	Calgary	Alberta	Canada
33	Univ of Alberta/Division of Inf Dis/Dept of Med	Edmonton	Alberta	Canada
34	Saint Paul's Hosp	Vancouver	British Columbia	Canada
35	Victoria Gen Hosp	Halifax	Nova Scotia	Canada
36	McMaster Univ Med Ctr	Hamilton	Ontario	Canada
37	Ottawa Gen Hosp	Ottawa	Ontario	Canada
38	Mount Sinai Hosp	Toronto	Ontario	Canada
39	Saint Michael's Hosp	Toronto	Ontario	Canada
40	Sunnybrook Health Science Ctr	Toronto	Ontario	Canada
41	Dr Emil Toma / Hotel Dieu de Montreal	Montreal	Quebec	Canada
42	Montreal Chest Institute	Montreal	Quebec	Canada
43	Montreal Gen Hosp	Montreal	Quebec	Canada