Clinical trial NCT00001995: A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mycobacterium Avium-Intracellulare Infection
HIV Infections
Keywords: Rifabutin
Mycobacterium avium-intracellulare Infection
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa County Med Ctr
state: Arizona
city: Harbor City
country: United States
facility: Bay Harbor Hosp
state: California
city: Irvine
country: United States
facility: Ctr for Special Immunology
state: California
city: Los Angeles
country: United States
facility: Southwest Community Based AIDS Treatment Group - COMBAT
state: California
city: Redwood City
country: United States
facility: AIDS Community Research Consortium
state: California
city: San Diego
country: United States
facility: HIV Research Group
state: California
city: San Francisco
country: United States
facility: Davies Med Ctr
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Administration Med Ctr
state: California
city: Washington
country: United States
facility: Veterans Administration Med Ctr
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: TheraFirst Med Ctrs Inc
state: Florida
city: Fort Lauderdale
country: United States
facility: Ctr for Special Immunology
state: Florida
city: Hollywood
country: United States
facility: Mem Hosp Hollywood
state: Florida
city: Miami
country: United States
facility: Miami Veterans Administration Med Ctr
state: Florida
city: Atlanta
country: United States
facility: Infectious Disease Research Consortium of Georgia
state: Georgia
city: Minneapolis
country: United States
facility: Dr Frank Rhame
state: Minnesota
city: Kansas City
country: United States
facility: Research Med Ctr
state: Missouri
city: Newark
country: United States
facility: North Jersey Community Research Initiative
state: New Jersey
city: East Meadow
country: United States
facility: Nassau County Med Ctr
state: New York
city: New York
country: United States
facility: Chelsea Village Med Ctr / Saint Vincent's Hosp
state: New York
city: Columbia
country: United States
facility: Dr Alfred F Burnside Jr
state: South Carolina
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
city: Milwaukee
country: United States
facility: Milwaukee County Med Complex
state: Wisconsin
Study officials:
References:
citation: Dautzenberg B, Castellani P, Pellegrin JL, Vittecoq D, Truffot-Pernot C, Pirotta N, Sassella D. Early bactericidal activity of rifabutin versus that of placebo in treatment of disseminated Mycobacterium avium complex bacteremia in AIDS patients. Antimicrob Agents Chemother. 1996 Jul;40(7):1722-5. doi: 10.1128/AAC.40.7.1722.