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The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used with or without Clofazimine in the Treatment of MAC in Patients with AIDS Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used with or without Clofazimine in the Treatment of MAC in Patients with AIDS conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used with or without Clofazimine in the Treatment of MAC in Patients with AIDS Clinical research trials and The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used with or without Clofazimine in the Treatment of MAC in Patients with AIDS health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used with or without Clofazimine in the Treatment of MAC in Patients with AIDS. The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used with or without Clofazimine in the Treatment of MAC in Patients with AIDS Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used with or without Clofazimine in the Treatment of MAC in Patients with AIDS clinical trial. Human subjects often get the best healthcare available for their The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used with or without Clofazimine in the Treatment of MAC in Patients with AIDS condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used with or without Clofazimine in the Treatment of MAC in Patients with AIDS  The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used with or without Clofazimine in the Treatment of MAC in Patients with AIDS
The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used with or without Clofazimine in the Treatment of MAC in Patients with AIDS
For Condition: Mycobacterium avium-intracellulare Infection,HIV Infections
Status: Completed
Sponsor(s): Abbott Laboratories ,
Synopsis: PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC). SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.
Details:
Eligibility:
Study Type: Interventional, Treatment, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - History of HIV seropositivity. - Disseminated MAC. - Positive blood culture for MAC within 4 weeks prior to study entry. - Consent of parent or guardian if less than 18 years of age. - Ability to complete the study. NOTE: - Patients with active opportunistic infections other than dMAC are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment. Exclusion Criteria Concurrent Medication: Excluded: - Active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels. - Active therapy with investigational drugs other than treatment for HIV disease, except with approval of the sponsor. - Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal). - Amikacin. - Azithromycin. - Capreomycin. - Ciprofloxacin. - Cycloserine. - Ethionamide. - Gentamicin. - Kanamycin. - Levofloxacin. - Lomefloxacin. - Ofloxacin. - Rifampin. - Rifabutin. - Sparfloxacin. - Streptomycin. - Any other aminoglycosides, quinolones, and macrolides. Patients with the following prior conditions are excluded: History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine. Prior Medication: Excluded: - Other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry. - Clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more than 14 days cumulative within the past 2 months.
Total Enrollment:
Location and Contact Information:
Dr Margaret Fischel
Miami, Florida, 33136
United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Santa Clara Valley Med Ctr
San Jose, California, 951282699
United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
United States
Vanderbilt Univ School of Medicine
Nashville, Tennessee, 37212
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21205
United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Kaiser Permanente Med Ctr
Los Angeles, California, 90027
United States
Dr Javier Morales
Condado San Juan, , 00907
Puerto Rico
Dr Stephen Hauptman
Philadelphia, Pennsylvania, 19107
United States
Tulane Univ Med School
New Orleans, Louisiana, 701122699
United States
UCD Med Ctr
Sacramento, California, 95817
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Saint Joseph's Hosp / Infectious Disease Rsch Institute
Tampa, Florida, 33614
United States
Additional Information:
Study ID Numbers: 214A; M93-069
Study Start Date:
Record last reviewed: March 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002331
Other Hiv Infections Studies:
1. Rapid HIV Tests for Women Late in Pregnancy and During Labor
2. The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
3. Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
4. 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
5. A Study of Megestrol Acetate in HIV-Infected Children
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The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used with or without Clofazimine in the Treatment of MAC in Patients with AIDS
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