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A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS Clinical research trials and A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS. A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS clinical trial. Test subjects typically receive the most expert healthcare available for their A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS  A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS
A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS
For Condition: Mycobacterium avium-intracellulare Infection,HIV Infections
Status: Completed
Sponsor(s): Pharmacia ,
Synopsis: To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population.
Details: Patients are randomized to receive oral rifabutin alone or rifabutin/ethambutol daily for 12 months, with possible continuation of medicine lifelong. Doses will be adjusted to maintain minimum blood levels of the drugs.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Pharmacodynamics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - AZT, d4T, ddI, or ddC. - Antipneumocystis prophylaxis. Allowed: - Short course (< 14 days) of ciprofloxacin for acute infections. Patients must have: - AIDS. - CD4 count <= 100 cells/mm3. - NO prior or current MAC infection. Prior Medication: Required: - Antipneumocystis prophylaxis for at least 4 weeks prior to study entry. Allowed: - Prior rifabutin. - Prior ethambutol. - Prior clarithromycin. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Positive tuberculin skin test (PPD > 5 mm). - Active M. tuberculosis. - Perceived as unreliable or unavailable for frequent monitoring. Concurrent Medication: Excluded: - Other antiretrovirals not specifically allowed. - All investigational drugs. - Other antimycobacterial therapy, such as clarithromycin, azithromycin, rifampin, clofazimine, amikacin, streptomycin, isoniazid, cycloserine, ethionamide, and ciprofloxacin (>= 14 days). Patients with the following prior conditions are excluded: Known hypersensitivity to rifabutin, rifampin, or other rifamycins and/or ethambutol. Prior Medication: Excluded within 4 weeks prior to study entry: - Rifampin. - Isoniazid. - Clofazimine. - Cycloserine. - Ethionamide. - Amikacin. - Ciprofloxacin.
Total Enrollment: 200
Location and Contact Information:
Univ of California - Davis Med Ctr / CARES
Sacramento, California, 95817
United States
Additional Information:
Study ID Numbers: 048E; CS 087287-000
Study Start Date:
Record last reviewed: June 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002343
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3. A Phase I/II Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease.
4. Prediction and Testing of Antigenic Sites of the AIDS Virus, HTLV-III Recognized by T Lymphocytes for the Development of Synthetic Vaccines
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A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS
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