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Last Updated: September 23, 2021

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CLINICAL TRIALS PROFILE FOR RIFABUTIN

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All Clinical Trials for Rifabutin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000826 ↗ Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To determine the effects of fluconazole and either rifabutin or clarithromycin, alone and in combination, on the pharmacokinetics of first sulfamethoxazole-trimethoprim and then dapsone in HIV-infected patients. Although prophylaxis for more than one opportunistic infection is emerging as a common clinical practice in patients with advanced HIV disease, little is known about possible adverse drug interactions. The need exists to define pharmacokinetics and pharmacodynamic adverse interactions of the many combination prophylactic regimens that may be prescribed.
NCT00000877 ↗ Study of How Indinavir (an Anti-HIV Drug) and Rifabutin (a Drug Used to Treat MAC, an HIV-Associated Disease) Interact in HIV-Positive and HIV-Negative Adults Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 The purpose of this study is to evaluate the safety of giving indinavir and rifabutin at the same time (simultaneously) vs 4 hours apart (staggered) to HIV-positive and HIV-negative adults. It is important to determine which medications for HIV-associated diseases, such as Mycobacterium avium complex (MAC) disease, can be given safely and effectively with anti-HIV drugs. Indinavir and rifabutin have been given simultaneously in the past with good results. This study seeks to examine if staggering the doses will make the 2 drugs more effective. HIV-negative volunteers are used in this study to examine the effect of rifabutin on indinavir and the effect of staggered rifabutin doses. The effect of rifabutin on the drug activity of indinavir is evaluated in HIV-positive patients.
NCT00001023 ↗ The Safety and Effectiveness of Rifabutin, Combined With Clarithromycin or Azithromycin, in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 PER 03/10/94 AMENDMENT: PART B. To determine whether there is an effect on plasma drug levels of azithromycin and rifabutin as measured by changes in the plasma concentration-time curve (AUC) when these drugs are taken concomitantly. ORIGINAL PRIMARY: To gain preliminary information about the safety and tolerance of clarithromycin and azithromycin in combination with rifabutin (three potential agents against Mycobacterium avium-intracellulare) in HIV-infected patients with CD4 counts < 200 cells/mm3. ORIGINAL SECONDARY: To determine whether there is an effect on the pharmacokinetics of the macrolide antibiotics or rifabutin when these drugs are taken concomitantly. To monitor the effect of rifabutin therapy on dapsone serum levels in patients taking dapsone for PCP prophylaxis. To monitor the effect of macrolide/rifabutin combination therapies on AZT or ddI serum levels. Two new macrolide antibiotics, clarithromycin and azithromycin, and rifabutin (a rifamycin derivative) have all demonstrated in vitro and in vivo activity against Mycobacterium avium-intracellulare, a common systemic bacterial infection complicating AIDS. Further information is needed, however, regarding the clinical and pharmacokinetic interaction of these drugs used in combination.
NCT00001030 ↗ The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 To compare the efficacy and safety of clarithromycin alone versus rifabutin alone versus the two drugs in combination for the prevention or delay of Mycobacterium avium Complex (MAC) bacteremia or disseminated MAC disease. To compare other parameters such as survival, toxicity, and quality of life among the three treatment arms. To obtain information on the incidence and clinical grade of targeted gynecologic conditions. Persons with advanced stages of HIV are considered to be at particular risk for developing disseminated MAC disease. The development of an effective regimen for the prevention of disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly the mortality associated with this disease and its treatment.
NCT00001039 ↗ Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To assess the feasibility of using culture and staining techniques to quantify tissue Mycobacterium avium Complex (MAC) burden in bone marrow. To correlate and compare changes in MAC bone marrow burden with quantitative MAC blood culture results at baseline and after 4 and 8 weeks of treatment. MAC is easiest to detect in the blood, although doctors generally believe that MAC in blood is just "spill-over" from infection of other parts of the body. Traditionally, studies of potential treatments for MAC focus only on MAC changes in the blood. This study compares MAC changes in blood to those in bone marrow, which is another tissue where MAC is often found.
NCT00001047 ↗ Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 To compare the safety and efficacy of two doses of clarithromycin in combination with ethambutol and either rifabutin or clofazimine for the treatment of disseminated Mycobacterium avium Complex (MAC) disease in AIDS patients. Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.
NCT00001058 ↗ A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients With AIDS Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To compare the efficacy and safety of clarithromycin combined with rifabutin, ethambutol, or both in the treatment of disseminated Mycobacterium avium Complex (MAC) disease in persons with AIDS, including individuals who have or have not received prior MAC prophylaxis. It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS. Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine, rifamycin derivatives, ethambutol, or the 4-quinolones.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rifabutin

Condition Name

Condition Name for Rifabutin
Intervention Trials
HIV Infections 29
Tuberculosis 22
Mycobacterium Avium-intracellulare Infection 13
Helicobacter Pylori Infection 5
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Condition MeSH

Condition MeSH for Rifabutin
Intervention Trials
HIV Infections 36
Infection 27
Tuberculosis 26
Mycobacterium Infections 23
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Clinical Trial Locations for Rifabutin

Trials by Country

Trials by Country for Rifabutin
Location Trials
United States 223
Canada 19
South Africa 6
France 3
Brazil 3
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Trials by US State

Trials by US State for Rifabutin
Location Trials
California 21
New York 16
Maryland 14
District of Columbia 12
Illinois 11
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Clinical Trial Progress for Rifabutin

Clinical Trial Phase

Clinical Trial Phase for Rifabutin
Clinical Trial Phase Trials
Phase 4 17
Phase 3 13
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Rifabutin
Clinical Trial Phase Trials
Completed 40
Not yet recruiting 18
Unknown status 8
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Clinical Trial Sponsors for Rifabutin

Sponsor Name

Sponsor Name for Rifabutin
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 12
Pfizer 7
Centers for Disease Control and Prevention 6
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Sponsor Type

Sponsor Type for Rifabutin
Sponsor Trials
Other 82
Industry 38
NIH 14
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