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Sponsored by: |
Pharmacia |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002080 |
Primary: To provide rifabutin to HIV positive patients in an attempt to prevent or delay Mycobacterium avium Complex (MAC) infection by a daily dose of rifabutin.
Secondary: To further characterize the safety of rifabutin monotherapy in preventing or delaying MAC bacteremia in HIV positive patients with CD4 counts = or < 200.
Condition | Intervention |
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Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Rifabutin |
Study Type: | Interventional |
Study Design: | Treatment, Dose Comparison |
Official Title: | Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in HIV Positive Patients With CD4 Counts = or < 200: Treatment IND Study |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior infection due to MAC or other mycobacterial disease or complaints consistent with tuberculosis.
Study ID Numbers: | 109A, 087085-999 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002080 |
Health Authority: | United States: Food and Drug Administration |
Rifabutin Acquired Immunodeficiency Syndrome AIDS-Related Complex Mycobacterium avium Complex Bacteremia |
Systemic Inflammatory Response Syndrome Bacterial Infections Sexually Transmitted Diseases, Viral Rifabutin Acquired Immunodeficiency Syndrome Bacteremia AIDS-Related Complex Mycobacterium Infections, Atypical Immunologic Deficiency Syndromes Inflammation |
Mycobacterium avium-intracellulare Infection Virus Diseases Gram-Positive Bacterial Infections Sepsis HIV Seropositivity HIV Infections Sexually Transmitted Diseases Mycobacterium Infections Mycobacterium avium complex infection Retroviridae Infections |
Communicable Diseases Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Infection Actinomycetales Infections |
Pharmacologic Actions Antibiotics, Antitubercular Anti-Bacterial Agents Pathologic Processes Therapeutic Uses Lentivirus Infections Antitubercular Agents |