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A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS Clinical research trials and A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS. A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS  A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS
A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS
For Condition: Mycobacterium avium-intracellulare Infection,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To compare the efficacy and safety of clarithromycin combined with rifabutin, ethambutol, or both in the treatment of disseminated Mycobacterium avium Complex (MAC) disease in persons with AIDS, including individuals who have or have not received prior MAC prophylaxis. It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS. Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine, rifamycin derivatives, ethambutol, or the 4-quinolones.
Details: It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS. Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine, rifamycin derivatives, ethambutol, or the 4-quinolones. Patients are randomized to one of three treatment arms containing clarithromycin in combination with ethambutol, rifabutin, or both. Clarithromycin alone is taken on days 1 through 3 to determine tolerance and rifabutin and/or ethambutol is added on day 3. AS PER AMENDMENT 7/2/97: Patients may elect to add ritonavir or indinavir to their treatment regimen. Treatment continues daily for 48 weeks. In the absence of a dose-limiting toxicity, those patients who are determined to be complete or partial responders continue on the regimen to which they were originally assigned. Patients who have failed or relapsed on originally assigned MAC therapy, must have their therapy amended to receive clarithromycin and at least two other drugs not included in their originally assigned regimen. Patients are followed twice in the first week, then every 2 weeks for the first 2 months, then monthly for the next 4 months, and then every 2 months thereafter until the end of 12 months. PER AMENDMENT 10/10/96: NOTE: Any patient who develops a toxicity to rifabutin or ethambutol after week 12 or thereafter will be offered the option of being registered to a salvage regimen of 2 new drugs not previously received, plus clarithromycin to continue for the study duration.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antiretroviral therapy. - Maintenance or prophylactic therapy for other opportunistic infections (with the exception of specifically excluded drugs). - Carbamazepine or theophylline. - Isoniazid for TB prophylaxis. PER AMENDMENT 10/10/96: - Therapy for acute infectious processes, other than MAC, provided that the patient is stable on the therapy. - Fluconazole therapy for maintenance or suppression of fungal infections, providing the patient has been on a stable dose for at least 4 weeks. PER AMENDMENT 7/02/97: - If a patient elects to receive indinavir, ORTHO/NOVUM 1/35 is an acceptable means of birth control. Patients must have: - HIV infection. - Disseminated MAC disease. - Life expectancy of at least 8 weeks. - Consent of parent or guardian if under 18 years of age. NOTE: - This protocol is approved for prisoner participation. Prior Medication: Allowed: PER AMENDMENT 10/10/96: - Therapy for acute infectious processes, other than MAC, prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Active mycobacterial infection other than MAC that requires treatment, with the exception of isoniazid used solely for TB prophylaxis. Concurrent Medication: Excluded: - Other antimycobacterial drugs (with the exception of isoniazid for TB prophylaxis). - Other investigational drugs unless approved by protocol chair. PER AMENDMENT 7/2/97: - For patients who elect to receive indinavir or ritonavir: - Terfenadine, astemizole, cisapride, triazolam, or midazolam. - For patients who elect to receive ritonavir: - alprazolam, amiodarone, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam, dihydroergotamine, ergotamine, estazolam, encainide, flecainide, flurazepam, meperidine, pimozide, piroxicam, propafenone, propoxyphene, quinidine or zolpidem. - For patients who elect to receive indinavir: - oral contraceptives other than ORTHO/NOVUM as a sole form of birth control. - For patients randomized to a rifabutin-containing arm: - oral contraceptives or Norplant as a sole form of birth control. Patients with the following prior condition are excluded: - History of severe hypersensitivity to erythromycin, clarithromycin, azithromycin, ethambutol, rifampin, or rifabutin (including Type 1 hypersensitivity reaction, Stevens-Johnson syndrome, hepatitis, optic neuritis, or exfoliative dermatitis). Prior Medication: Excluded: - Empiric or presumptive antimycobacterial therapy prior to study entry if > 14 days, within 90 days prior to entry. NOTE: - Patients unwilling to discontinue presumptive therapy or empiric therapy may be enrolled with the permission of the protocol chairs, however, if they are without a MAC positive blood culture at baseline, they will have study medications discontinued (AS PER AMENDMENT 7/2/97). PER AMENDMENT 10/10/96: - Treatment with clarithromycin or ethambutol within 4 days of initiation of study medications. - Treatment with rifabutin or rifampin within 7 days of initiation of study medications.
Total Enrollment: 246
Location and Contact Information:
Overall Study Official:
BensonCA, Study Chair,
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Med Ctr Clinic
Pensacola, Florida, 325241151
United States
Kaiser Permanente Franklin Med Ctr
Denver, Colorado, 80262
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Rose Med Ctr
Denver, Colorado, 80262
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med Ctr
Los Angeles, California, 900334508
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Hennepin County Med Clinic
Minneapolis, Minnesota, 55415
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
St Petersburg Med Clinics
St. Petersburg, Florida, 33705
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
St Paul Ramsey Med Ctr
St. Paul, Minnesota, 55101
United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Columbia Presbyterian Med Ctr
New York City, New York, 100323784
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Olive View Med Ctr
Sylmar, California, 91342
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Wishard Hosp / Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Regional Oncology Ctr
Daytona Beach, Florida, 32015
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Additional Information:
Study ID Numbers: ACTG 223;
Study Start Date:
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001058
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3. Zidovudine Levels in HIV Infected Patients Being Treated for HCV
4. A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
5. A Study of LXR015-1 in HIV-Infected Patients
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A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS
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