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| Sponsored by: |
Pfizer |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002140 |
Purpose
To evaluate the efficacy and safety of two different doses of azithromycin in combination with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC) infection, and to determine whether an azithromycin-containing regimen is at least as safe and effective as the same regimen containing clarithromycin..
| Condition | Intervention | Phase |
|---|---|---|
|
Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Ethambutol hydrochloride Drug: Clarithromycin Drug: Azithromycin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients |
Patients are randomized to receive azithromycin at one of two doses in combination with ethambutol or clarithromycin in combination with ethambutol for 24 weeks, after which they are evaluated for entry into a maintenance phase of treatment. Clinical, microbiologic, and safety assessments are performed every 3 weeks for the first 12 weeks, then monthly for the remaining 12 weeks.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Contacts and Locations| United States, California | |
| Infectious Disease Med Group / Adult Immunology Clinic | |
| Oakland, California, United States, 94609 | |
| Santa Clara Valley Med Ctr | |
| San Jose, California, United States, 951282699 | |
| UCI Med Ctr | |
| Orange, California, United States, 92668 | |
| Dr Milton Estes | |
| Mill Valley, California, United States, 94941 | |
| Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| United States, Connecticut | |
| Pfizer Central Research | |
| Groton, Connecticut, United States, 06340 | |
| United States, District of Columbia | |
| Whitman - Walker Clinic | |
| Washington, District of Columbia, United States, 20009 | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Med Service | |
| Miami, Florida, United States, 33125 | |
| Bay Area AIDS Consortium | |
| Tampa, Florida, United States, 33609 | |
| Dr Robert Wallace | |
| St. Petersburg, Florida, United States, 33713 | |
| United States, Georgia | |
| West Paces Clinical Research Inc | |
| Atlanta, Georgia, United States, 30327 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| Dr Neel French / Louis A Weiss Memorial Hosp | |
| Chicago, Illinois, United States, 60640 | |
| United States, Louisiana | |
| Oschner Clinic | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Missouri | |
| Trinity Lutheran Hosp / Infectious Disease Clinic | |
| Kansas City, Missouri, United States, 64108 | |
| United States, North Carolina | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 27710 | |
| United States, Texas | |
| Dr Gary Brewton | |
| Houston, Texas, United States, 77027 | |
| Univ of Texas Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 75235 | |
| Austin Infectious Disease Consultants | |
| Austin, Texas, United States, 78705 | |
| Thomas Street Clinic / Baylor College of Medicine | |
| Houston, Texas, United States, 77009 | |
| Central Texas Med Foundation | |
| Austin, Texas, United States, 78751 | |
| United States, Virginia | |
| Hampton Roads Med Specialists | |
| Hampton, Virginia, United States, 23666 | |
More Information
| Study ID Numbers: | 226B, 066-189, 189/189B |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002140 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Mycobacterium avium-intracellulare Infection Drug Therapy, Combination Ethambutol |
Acquired Immunodeficiency Syndrome Azithromycin Clarithromycin |
|
Bacterial Infections Anti-Infective Agents Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Mycobacterium Infections, Atypical Mycobacterium Avium Complex Infection Mycobacterium avium-intracellulare Infection Virus Diseases Anti-Bacterial Agents |
Clarithromycin Gram-Positive Bacterial Infections HIV Infections Azithromycin Sexually Transmitted Diseases Mycobacterium Infections Ethambutol Antitubercular Agents Retroviridae Infections |
|
Bacterial Infections Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Clarithromycin Anti-Bacterial Agents Gram-Positive Bacterial Infections Therapeutic Uses Azithromycin Retroviridae Infections RNA Virus Infections Immune System Diseases |
Acquired Immunodeficiency Syndrome Enzyme Inhibitors Pharmacologic Actions Immunologic Deficiency Syndromes Actinomycetales Infections Mycobacterium Infections, Atypical Mycobacterium avium-intracellulare Infection Virus Diseases Protein Synthesis Inhibitors HIV Infections Sexually Transmitted Diseases Lentivirus Infections Mycobacterium Infections Ethambutol Antitubercular Agents |
