The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS
Mycobacterium Avium-intracellular Infection, HIV Infections
About this trial
This is an interventional treatment trial for Mycobacterium Avium-intracellular Infection focused on measuring Mycobacterium avium-intracellular Infection, Drug Therapy, Combination, Ethambutol, Clofazimine, Acquired Immunodeficiency Syndrome, Clarithromycin
Eligibility 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.
Sites / Locations
- Kaiser Permanente Med Ctr
- UCD Med Ctr
- Kaiser Permanente Med Ctr
- Santa Clara Valley Med Ctr
- George Washington Univ Med Ctr
- Dr Margaret Fischel
- Saint Joseph's Hosp / Infectious Disease Rsch Institute
- Rush Presbyterian - Saint Luke's Med Ctr
- Tulane Univ Med School
- Johns Hopkins Univ School of Medicine
- Beth Israel Med Ctr
- Mount Sinai Med Ctr
- Univ of North Carolina School of Medicine
- Dr Stephen Hauptman
- Vanderbilt Univ School of Medicine
- Univ of Texas Southwestern Med Ctr of Dallas
- Houston Veterans Administration Med Ctr
- Dr Javier Morales