|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Pharmacia |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002032 |
Purpose
The primary objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC in these patients. A secondary objective is to compare clinical response, quality of life (Karnofsky), and survival between these two groups.
| Condition | Intervention |
|---|---|
|
Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Rifabutin |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind |
| Official Title: | 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 4 weeks of study entry:
Required:
Required for at least 4 weeks prior to study entry:
Contacts and Locations
Hide Study Locations| United States, California | |
| Olive View Med Ctr | |
| Sylmar, California, United States, 91342 | |
| Ctr for Special Immunology | |
| Irvine, California, United States, 92718 | |
| United States, Colorado | |
| Denver Public Health Dept | |
| Denver, Colorado, United States, 80204 | |
| United States, District of Columbia | |
| Veterans Administration Med Ctr | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Florida | |
| TheraFirst Med Ctrs Inc | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Mem Hosp Hollywood | |
| Hollywood, Florida, United States, 33021 | |
| VP Med Services / HHCS Research Institute Inc | |
| Orlando, Florida, United States, 32806 | |
| Ctr for Special Immunology | |
| Fort Lauderdale, Florida, United States, 33308 | |
| United States, Georgia | |
| Grady Memorial Hosp / Hughs Spalding Med Ctr | |
| Atlanta, Georgia, United States, 30335 | |
| Dr Winkler Weinberg | |
| Roswell, Georgia, United States, 30076 | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Maryland | |
| Johns Hopkins School of Medicine | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| CRI of New England | |
| Brookline, Massachusetts, United States, 02445 | |
| United States, Missouri | |
| Univ of Missouri at Kansas City School of Medicine | |
| Kansas City, Missouri, United States, 64108 | |
| Research Med Ctr | |
| Kansas City, Missouri, United States, 64132 | |
| United States, New York | |
| Nassau County Med Ctr | |
| East Meadow, New York, United States, 11554 | |
| Brooklyn Veterans Administration | |
| Brooklyn, New York, United States, 11209 | |
| Chelsea Village Med Ctr | |
| New York, New York, United States, 10014 | |
| Maimonides Med Ctr | |
| Brooklyn, New York, United States, 11219 | |
| Community Research Initiative | |
| New York, New York, United States, 10011 | |
| Long Island Jewish Med Ctr | |
| New Hyde Park, New York, United States, 11042 | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| United States, Ohio | |
| Ohio State Univ Med Ctr | |
| Columbus, Ohio, United States, 43210 | |
| Univ Hosp of Cleveland / Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Texas | |
| Univ TX San Antonio Health Science Ctr | |
| San Antonio, Texas, United States, 78284 | |
| Central Texas Med Foundation | |
| Austin, Texas, United States, 78751 | |
| Nelson Tebedo Community Clinic | |
| Dallas, Texas, United States, 75219 | |
| Dr Scott Lea | |
| Waco, Texas, United States, 76708 | |
| Scott and White Hosp | |
| Temple, Texas, United States, 76508 | |
| Texas Tech Health Sciences Ctr | |
| El Paso, Texas, United States, 79905 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77005 | |
| Houston Clinical Research Network | |
| Houston, Texas, United States, 77266 | |
| Univ of Texas Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 75235 | |
More Information
| Study ID Numbers: | 048A, 087023-999 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002032 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Rifabutin AIDS-Related Opportunistic Infections Mycobacterium avium-intracellulare Infection Acquired Immunodeficiency Syndrome Antitubercular Agents |
|
Bacterial Infections Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Rifabutin Infection Anti-Bacterial Agents Gram-Positive Bacterial Infections Pathologic Processes Therapeutic Uses Retroviridae Infections Systemic Inflammatory Response Syndrome RNA Virus Infections Immune System Diseases |
Acquired Immunodeficiency Syndrome Bacteremia Pharmacologic Actions Immunologic Deficiency Syndromes Actinomycetales Infections Mycobacterium Infections, Atypical Antibiotics, Antitubercular Mycobacterium avium-intracellulare Infection Inflammation Virus Diseases Sepsis HIV Infections Sexually Transmitted Diseases Lentivirus Infections Mycobacterium Infections |