|
A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo Clinical research trials and A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo. A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo
A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo
For Condition: Mycobacterium avium-intracellulare Infection,HIV Infections
Status: Completed
Sponsor(s): Pharmacia ,
Synopsis: To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.
Details: Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Isoniazid for TB prophylaxis ONLY. Patients must have: - HIV infection. - MAC infection. - Life expectancy of at least 16 weeks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Perceived unreliability or unavailability for frequent monitoring. Concurrent Medication: Excluded: - Antimycobacterial drugs other than the study drugs. - Carbamazepine. - Terfenadine. - Theophylline. Patients with the following prior condition are excluded: History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol. Prior Medication: Excluded within 7 days prior to study entry: - Rifabutin. - Rifampin. - Ethionamide. - Cycloserine. - Clofazimine. - Ethambutol. - Amikacin. - Ciprofloxacin. - Ofloxacin. - Sparfloxacin. - Azithromycin. - Clarithromycin. - Pyrazinamide. Excluded within 14 days prior to study entry: - Carbamazepine. - Terfenadine. - Theophylline.
Total Enrollment: 450
Location and Contact Information:
Dr Arnold Markowitz
Keego Harbor, Michigan, 48320
United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
United States
Central Texas Med Foundation
Austin, Texas, 78751
United States
Saint Francis Mem Hosp
San Francisco, California, 94109
United States
HIV Research Group
San Diego, California, 92102
United States
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, 07018
United States
Nalle Clinic
Charlotte, North Carolina, 28207
United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226
United States
Ctr for Special Immunology
Irvine, California, 92718
United States
Univ of Wisconsin School of Medicine
Madison, Wisconsin, 53792
United States
Community Health Network
Rochester, New York, 14620
United States
Bay Area AIDS Consortium
Tampa, Florida, 33609
United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422
United States
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, 681985130
United States
Infectious Disease Consultants
Altamonte Springs, Florida, 32701
United States
TheraFirst Med Ctrs Inc
Ft. Lauderdale, Florida, 33308
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Long Island Jewish Med Ctr
New Hyde Park, New York, 11042
United States
Dr Barry Rodwick
Safety Harbor, Florida, 34695
United States
Tulane Univ Med School
New Orleans, Louisiana, 701122699
United States
Sunnyvale Med Clinic
Sunnyvale, California, 94086
United States
McDowell Clinic
Phoenix, Arizona, 85006
United States
Dr Daniel Berger
Chicago, Illinois, 60657
United States
Gary Richmond MD
Ft. Lauderdale, Florida, 33316
United States
Dr Nelson Zide
Hollywood, Florida, 33021
United States
Polyclinic Med Ctr
Harrisburg, Pennsylvania, 17110
United States
Charleston Veterans Administration Med Ctr
Charleston, South Carolina, 294015799
United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
United States
Combat Group
Los Angeles, California, 90028
United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
United States
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018
United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
United States
Bay Harbor Hosp
Harbor City, California, 90710
United States
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, 30345
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
Dr Alfred F Burnside Jr
Columbia, South Carolina, 29204
United States
Chelsea Village Med Ctr / Saint Vincent's Hosp
New York City, New York, 10014
United States
UCSD / Ctr for Special Immunology
San Diego, California, 92103
United States
Dr Frank Tornaka
Ft. Lauderdale, Florida, 33316
United States
Cedars Sinai Med Ctr
Los Angeles, California, 90048
United States
Ctr for Special Immunology
Miami, Florida, 33140
United States
Maricopa Med Research Foundation
Phoenix, Arizona, 85008
United States
Additional Information:
Study ID Numbers: 048D; CS 087250-999
Study Start Date:
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002101
Other Hiv Infections Studies:
1. A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
2. A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy
3. A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients
4. A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients
5. The Effects of Anti-HIV Therapy on the Immune Systems of Children Infected With HIV
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Irvine Clinical Trials
A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo
|
|
|
|
|
|
|
|