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A Prospective, Randomized, Comparative Study of the Safety and Efficacy of Clarithromycin Versus Rifabutin Versus the Combination of Clarithromycin Plus Rifabutin for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia or Disseminated MAC Disease in HIV-Infected Patients With CD4 Lymphocyte Counts <= 100 Cells/mm3


Phase 3
12 Years
N/A
Not Enrolling
Both
Mycobacterium Avium-intracellulare Infection, HIV Infections

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Trial Information

A Prospective, Randomized, Comparative Study of the Safety and Efficacy of Clarithromycin Versus Rifabutin Versus the Combination of Clarithromycin Plus Rifabutin for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia or Disseminated MAC Disease in HIV-Infected Patients With CD4 Lymphocyte Counts <= 100 Cells/mm3


Persons with advanced stages of HIV are considered to be at particular risk for developing
disseminated MAC disease. The development of an effective regimen for the prevention of
disseminated MAC disease may be of substantial benefit in altering the morbidity and
possibly the mortality associated with this disease and its treatment.

Patients are randomized to receive clarithromycin alone, rifabutin alone, or the two drugs
in combination daily. Patients are evaluated every 4 weeks for the first 8 weeks and every 8
weeks thereafter for the duration of the study. Patients are followed for 24 months. Per
amendment, a pharmacokinetic substudy will be conducted.

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Recommended:

- PCP prophylaxis.

Allowed:

- GM-CSF or G-CSF.

- Erythropoietin.

- Therapies (including antiretrovirals) available through expanded access or treatment
IND programs.

- Other non-experimental therapies available by prescription.

- Antihistamines other than those specifically excluded.

Patients must have:

- Evidence or diagnosis of HIV infection or a history of an AIDS-defining condition by
CDC criteria.

- CD4 count <= 100 cells/mm3 within 90 days prior to study entry.

- Two baseline blood sample cultures negative for MAC within 30 days of study entry.

- No suspected disseminated MAC disease, in the opinion of the clinician.

NOTE:

- Patients with elevated GGT and/or triglycerides are allowed.

NOTE:

- Patients may co-enroll on ACTG 081/981/181, ACTG 175, ACTG 204, ACTG 193, ACTG 241,
or other acceptable protocols.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Known or suspected tuberculous infection or other non-tuberculous mycobacterial
infection requiring chemotherapy or chemoprophylaxis (with the exception of isoniazid
prophylaxis alone).

NOTE:

- Patients may enroll who successfully completed tuberculosis (TB) treatment and have
been off anti-TB drugs for more than 6 months with no symptoms of mycobacterial
infection.

- Active TB.

- Known hypersensitivity to study drugs.

- Malabsorption as defined by persistent diarrhea with more than 8 stools per day for >
6 weeks.

Concurrent Medication:

Excluded:

- Frequent (more than once per month), repeated, or continuous treatment courses of
quinolones, erythromycin, spiramycin, azithromycin, clarithromycin, or clindamycin.

- Concomitant terfenadine or astemizole.

Prior Medication:

Excluded:

- Prophylaxis with azithromycin, clarithromycin, or rifabutin for more than 4 months.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Benson CA

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 196

NCT ID:

NCT00001030

Start Date:

Completion Date:

June 1996

Related Keywords:

  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections
  • Rifabutin
  • Mycobacterium avium-intracellulare Infection
  • Acquired Immunodeficiency Syndrome
  • Clarithromycin
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Mycobacterium Infections
  • Mycobacterium avium-intracellulare Infection

Name

Location

Alabama Therapeutics CRSBirmingham, Alabama  35294
UCLA CARE Center CRSLos Angeles, California  90095
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.Oakland, California  94609
Ucsf Aids CrsSan Francisco, California  
Howard University Hosp., Div. of Infectious Diseases, ACTUWashington, District of Columbia  20059
Univ. of Miami AIDS CRSMiami, Florida  33136
Univ. of Hawaii at Manoa, Leahi Hosp.Honolulu, Hawaii  96816
Northwestern University CRSChicago, Illinois  60611
Rush Univ. Med. Ctr. ACTG CRSChicago, Illinois  60612
Cook County Hosp. CORE Ctr.Chicago, Illinois  60612
Indiana Univ. School of Medicine, Infectious Disease Research ClinicIndianapolis, Indiana  46202
Methodist Hosp. of IndianaIndianapolis, Indiana  46202
Univ. of Iowa Healthcare, Div. of Infectious DiseasesIowa City, Iowa  52242
Johns Hopkins Adult AIDS CRSBaltimore, Maryland  21287
Massachusetts General Hospital ACTG CRSBoston, Massachusetts  02114
Beth Israel Deaconess - East Campus A0102 CRSBoston, Massachusetts  02215
Beth Israel Deaconess Med. Ctr., ACTG CRSBoston, Massachusetts  02215
Bmc Actg CrsBoston, Massachusetts  02118
Hennepin County Med. Ctr., Div. of Infectious DiseasesMinneapolis, Minnesota  55455
University of Minnesota, ACTUMinneapolis, Minnesota  
St. Louis ConnectCare, Infectious Diseases ClinicSt Louis, Missouri  63112
Washington U CRSSt. Louis, Missouri  
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.Omaha, Nebraska  
SUNY - Buffalo, Erie County Medical Ctr.Buffalo, New York  14215
NY Univ. HIV/AIDS CRSNew York, New York  10016
Memorial Sloan-Kettering Cancer Ctr.New York, New York  10021
Cornell University A2201New York, New York  10021
Beth Israel Med. Ctr. (Mt. Sinai)New York, New York  10003
Univ. of Rochester ACTG CRSRochester, New York  14642
Unc Aids CrsChapel Hill, North Carolina  27599
Carolinas HealthCare System, Carolinas Med. Ctr.Charlotte, North Carolina  28203
Regional Center for Infectious Disease, Wendover Medical Center CRSGreensboro, North Carolina  27401
Univ. of Cincinnati CRSCincinnati, Ohio  45267
Case CRSCleveland, Ohio  44106
MetroHealth CRSCleveland, Ohio  
The Ohio State Univ. AIDS CRSColumbus, Ohio  43210
Hosp. of the Univ. of Pennsylvania CRSPhiladelphia, Pennsylvania  19104
University of Washington AIDS CRSSeattle, Washington  98122
Bronx-Lebanon Hosp. IMPAACT CRSBronx, New York  10457
Chicago Children's CRSChicago, Illinois  60611
The Children's Hosp. of Philadelphia IMPAACT CRSPhiladelphia, Pennsylvania  19104