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| 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
Show 33 Study Locations
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 |
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Rifabutin AIDS-Related Opportunistic Infections Mycobacterium avium-intracellulare Infection Acquired Immunodeficiency Syndrome Antitubercular Agents |
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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 |