Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 066-189 | |||
| 189/189B |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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..
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethambutol hydrochloride | Drug | |||
| Clarithromycin | Drug | |||
| Azithromycin | Drug |
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Bay AIDS Ctr | Berkeley | California | 94705 | United States | ||
| Dr Milton Estes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11073759 | Background | Dunne M, Fessel J, Kumar P, Dickenson G, Keiser P, Boulos M, Mogyros M, White AC Jr, Cahn P, O'Connor M, Lewi D, Green S, Tilles J, Hicks C, Bissett J, Schneider MM, Benner R. A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus. Clin Infect Dis. 2000 Nov;31(5):1245-52. doi: 10.1086/317468. Epub 2000 Nov 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mill Valley |
| California |
| 94941 |
| United States |
| Infectious Disease Med Group / Adult Immunology Clinic | Oakland | California | 94609 | United States |
| UCI Med Ctr | Orange | California | 92668 | United States |
| Kaiser Permanente Med Ctr | San Francisco | California | 94115 | United States |
| Santa Clara Valley Med Ctr | San Jose | California | 951282699 | United States |
| Pfizer Central Research | Groton | Connecticut | 06340 | United States |
| Georgetown Univ Med Ctr | Washington D.C. | District of Columbia | 20007 | United States |
| Whitman - Walker Clinic | Washington D.C. | District of Columbia | 20009 | United States |
| Med Service | Miami | Florida | 33125 | United States |
| Dr Robert Wallace | St. Petersburg | Florida | 33713 | United States |
| Bay Area AIDS Consortium | Tampa | Florida | 33609 | United States |
| West Paces Clinical Research Inc | Atlanta | Georgia | 30327 | United States |
| Northwestern Univ Med School | Chicago | Illinois | 60611 | United States |
| Dr Neel French / Louis A Weiss Memorial Hosp | Chicago | Illinois | 60640 | United States |
| Oschner Clinic | New Orleans | Louisiana | 70121 | United States |
| Trinity Lutheran Hosp / Infectious Disease Clinic | Kansas City | Missouri | 64108 | United States |
| Duke Univ Med Ctr | Durham | North Carolina | 27710 | United States |
| Austin Infectious Disease Consultants | Austin | Texas | 78705 | United States |
| Central Texas Med Foundation | Austin | Texas | 78751 | United States |
| Univ of Texas Southwestern Med Ctr of Dallas | Dallas | Texas | 75235 | United States |
| Thomas Street Clinic / Baylor College of Medicine | Houston | Texas | 77009 | United States |
| Dr Gary Brewton | Houston | Texas | 77027 | United States |
| Hampton Roads Med Specialists | Hampton | Virginia | 23666 | United States |
| ID | Term |
|---|---|
| D015270 | Mycobacterium avium-intracellulare Infection |
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D009165 | Mycobacterium Infections, Nontuberculous |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004977 | Ethambutol |
| D017291 | Clarithromycin |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
Not provided
Not provided