Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in HIV Positive Patients With CD4 Counts = or < 200: Treatment IND Study
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ClinicalTrials.gov Identifier: NCT00002080 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
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Tracking Information | |||
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First Submitted Date ICMJE | November 2, 1999 | ||
First Posted Date ICMJE | August 31, 2001 | ||
Last Update Posted Date | June 24, 2005 | ||
Study Start Date ICMJE | Not Provided | ||
Primary Completion Date | Not Provided | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in HIV Positive Patients With CD4 Counts = or < 200: Treatment IND Study | ||
Official Title ICMJE | Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in HIV Positive Patients With CD4 Counts = or < 200: Treatment IND Study | ||
Brief Summary | 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. |
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Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Not Applicable | ||
Study Design ICMJE | Primary Purpose: Treatment | ||
Condition ICMJE |
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Intervention ICMJE | Drug: Rifabutin | ||
Study Arms | Not Provided | ||
Publications * | Gordin F, Masur H. Prophylaxis of Mycobacterium avium complex bacteremia in patients with AIDS. Clin Infect Dis. 1994 Apr;18 Suppl 3:S223-6. Review. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE | Not Provided | ||
Original Enrollment ICMJE | Not Provided | ||
Study Completion Date | Not Provided | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | 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. |
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Sex/Gender |
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Ages | 12 Years and older (Child, Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00002080 | ||
Other Study ID Numbers ICMJE | 109A 087085-999 |
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Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Pharmacia | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | NIH AIDS Clinical Trials Information Service | ||
Verification Date | April 2003 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |