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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


N/A
18 Years
N/A
Not Enrolling
Both
Mycobacterium Avium-Intracellulare Infection, HIV Infections

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Trial Information

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

Inclusion Criteria


Inclusion Criteria

Patients must have the following:

- Diagnosis of AIDS with a case defining infection other than Mycobacterium avium
complex (MAC).

- Written informed consent.

- Females of childbearing potential must also sign a special informed consent.

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.

Type of Study:

Interventional

Study Design:

Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

048A

NCT ID:

NCT00002032

Start Date:

Completion Date:

Related Keywords:

  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections
  • Rifabutin
  • AIDS-Related Opportunistic Infections
  • Mycobacterium avium-intracellulare Infection
  • Acquired Immunodeficiency Syndrome
  • Antitubercular Agents
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Bacteremia
  • Mycobacterium Infections
  • Mycobacterium avium-intracellulare Infection

Name

Location

Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Olive View Med CtrSylmar, California  91342
Univ Hosp of Cleveland / Case Western Reserve UnivCleveland, Ohio  44106
AIDS Research Consortium of AtlantaAtlanta, Georgia  30308
Univ of Texas Southwestern Med Ctr of DallasDallas, Texas  75235
Baylor College of MedicineHouston, Texas  77030
Univ TX San Antonio Health Science CtrSan Antonio, Texas  782847881
Scott and White HospTemple, Texas  76508
Ctr for Special ImmunologyIrvine, California  92718
Denver Public Health DeptDenver, Colorado  80204
Veterans Administration Med CtrWashington, District of Columbia  20422
Ctr for Special ImmunologyFort Lauderdale, Florida  33308
TheraFirst Med Ctrs IncFort Lauderdale, Florida  33308
Mem Hosp HollywoodHollywood, Florida  33021
VP Med Services / HHCS Research Institute IncOrlando, Florida  32806
Grady Memorial Hosp / Hughs Spalding Med CtrAtlanta, Georgia  30335
Dr Winkler WeinbergRoswell, Georgia  30076
Johns Hopkins School of MedicineBaltimore, Maryland  21205
CRI of New EnglandBrookline, Massachusetts  02445
Research Med CtrKansas City, Missouri  64132
Univ of Missouri at Kansas City School of MedicineKansas City, Missouri  64108
Brooklyn Veterans AdministrationBrooklyn, New York  11209
Maimonides Med CtrBrooklyn, New York  11219
Nassau County Med CtrEast Meadow, New York  11554
Long Island Jewish Med CtrNew Hyde Park, New York  11042
Chelsea Village Med CtrNew York, New York  10014
Community Research InitiativeNew York, New York  10011
Ohio State Univ Med CtrColumbus, Ohio  43210
Central Texas Med FoundationAustin, Texas  78751
Nelson Tebedo Community ClinicDallas, Texas  75219
Texas Tech Health Sciences CtrEl Paso, Texas  79905
Houston Clinical Research NetworkHouston, Texas  77266
Dr Scott LeaWaco, Texas  76708