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Last Updated: February 12, 2025

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rifabutin

Condition Name

Condition Name for Rifabutin
Intervention Trials
HIV Infections 30
Tuberculosis 21
Mycobacterium Avium-intracellulare Infection 13
Helicobacter Pylori Infection 6
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Condition MeSH

Condition MeSH for Rifabutin
Intervention Trials
HIV Infections 38
Infections 30
Infection 27
Tuberculosis 26
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Clinical Trial Locations for Rifabutin

Trials by Country

Trials by Country for Rifabutin
Location Trials
United States 248
Canada 20
South Africa 8
China 4
Uganda 4
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Trials by US State

Trials by US State for Rifabutin
Location Trials
California 22
New York 17
Maryland 15
Texas 14
District of Columbia 12
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Clinical Trial Progress for Rifabutin

Clinical Trial Phase

Clinical Trial Phase for Rifabutin
Clinical Trial Phase Trials
Phase 4 18
Phase 3 12
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Rifabutin
Clinical Trial Phase Trials
Completed 50
Recruiting 14
Unknown status 9
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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
Pharmacia 6
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Sponsor Type

Sponsor Type for Rifabutin
Sponsor Trials
Other 91
Industry 46
NIH 14
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Clinical Trials, Market Analysis, and Projections for Rifabutin

Introduction

Rifabutin, a rifamycin antibiotic, is widely used in the treatment and prevention of Mycobacterium avium complex (MAC) disease, particularly in patients with advanced HIV infection. This article provides an update on recent clinical trials, market analysis, and future projections for rifabutin.

Clinical Trials Update

Comparison of Rifabutin and Rifampin

A recent meta-analysis compared the treatment success rates of rifabutin-based versus rifampin-based regimens for MAC disease. The study found that the pooled treatment success rate was 54.7% for rifabutin groups and 67.5% for rifampin groups, suggesting that rifampin may lead to better treatment outcomes, especially in older HIV patients who may have decreased tolerability to rifabutin[1].

Pharmacokinetic Interactions

Clinical trials have highlighted the significant pharmacokinetic interactions between rifabutin and various antiretroviral therapies. For instance, co-administration of rifabutin with lopinavir/ritonavir can increase rifabutin concentrations, necessitating dose adjustments. A randomized pharmacokinetic trial recommended that rifabutin 150 mg daily may be preferred when co-administered with lopinavir/ritonavir to maintain optimal drug levels[4].

Drug-Drug Interactions

Rifabutin's interactions with other medications are a critical consideration. Studies have shown that rifabutin can induce hepatic metabolic enzymes, particularly those of the CYP3A subfamily, which can affect the plasma concentrations of concomitantly administered drugs. For example, co-administration with antiretrovirals like atazanavir/ritonavir, lopinavir/ritonavir, and saquinavir/ritonavir requires significant dose reductions of rifabutin to avoid adverse reactions[2][3].

Market Analysis

Current Market Position

Rifabutin is currently indicated for the prevention of disseminated MAC disease in patients with advanced HIV infection. It is marketed under the brand name Mycobutin, among others. The drug's market is primarily driven by its use in managing opportunistic infections in HIV patients.

Competitive Landscape

The market for rifamycin antibiotics is competitive, with rifampin being a major competitor. However, rifabutin has an advantage due to its fewer drug-drug interactions, making it easier to implement in clinical practice, especially in patients on multiple medications[5].

Patient Population

The patient population for rifabutin includes those with advanced HIV infection, particularly those with CD4+ counts below 50 cells/mm³. The increasing longevity of HIV patients due to advancements in antiretroviral therapies has expanded the potential market for rifabutin, as older patients may require more tailored treatment approaches[1].

Market Projections

Growth Drivers

Several factors are expected to drive the growth of the rifabutin market:

  • Increasing HIV Prevalence: Despite advancements in HIV treatment, the global prevalence of HIV remains significant, ensuring a steady demand for rifabutin.
  • Aging HIV Population: As HIV patients live longer due to improved antiretroviral therapies, the need for rifabutin in managing opportunistic infections like MAC disease is likely to increase.
  • Fewer Drug-Drug Interactions: Compared to rifampin, rifabutin's fewer drug-drug interactions make it a more manageable option for patients on multiple medications, potentially increasing its market share[5].

Challenges

Despite these growth drivers, there are challenges that could impact the market:

  • Side Effects and Tolerability: Rifabutin's decreased tolerability in older patients and potential for adverse reactions when co-administered with other medications could limit its use.
  • Regulatory Environment: Changes in regulatory guidelines or the approval of new drugs with fewer side effects could impact the market position of rifabutin[1][3].

Future Research Directions

Need for Randomized Controlled Trials

There is a need for large, randomized controlled trials to compare the efficacy of rifabutin versus rifampin in different patient subgroups, including HIV and non-HIV patients, and those with disseminated and non-disseminated MAC disease. Such trials would help in establishing clear clinical practice guidelines for MAC treatment[1].

Addressing Drug-Drug Interactions

Further research is required to optimize the dosing of rifabutin when co-administered with other medications, particularly antiretrovirals, to minimize adverse reactions and ensure therapeutic efficacy.

Key Takeaways

  • Treatment Success Rates: Rifampin may have higher treatment success rates compared to rifabutin for MAC disease, especially in older HIV patients.
  • Pharmacokinetic Interactions: Rifabutin has significant interactions with antiretroviral therapies, requiring careful dose adjustments.
  • Market Position: Rifabutin's market is driven by its use in managing opportunistic infections in HIV patients, with an advantage due to fewer drug-drug interactions.
  • Growth Drivers: Increasing HIV prevalence, an aging HIV population, and fewer drug-drug interactions are expected to drive market growth.
  • Challenges: Side effects, tolerability issues, and regulatory changes could impact the market.

FAQs

What is the primary indication for rifabutin?

Rifabutin is primarily indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection[2].

How does rifabutin interact with antiretroviral therapies?

Rifabutin can significantly interact with antiretroviral therapies, leading to increased concentrations of rifabutin and its metabolites, necessitating dose reductions to avoid adverse reactions[2][4].

Why is rifabutin preferred over rifampin in some cases?

Rifabutin is preferred due to its fewer drug-drug interactions, making it easier to manage in patients on multiple medications[5].

What are the potential side effects of rifabutin?

Rifabutin can cause various side effects, including gastrointestinal issues, liver enzyme elevations, and interactions with other medications that may lead to adverse reactions[3].

Are there any ongoing or planned clinical trials for rifabutin?

There is a need for large, randomized controlled trials to compare the efficacy of rifabutin versus rifampin in different patient subgroups, but specific ongoing trials are not detailed in recent literature[1].

Sources

  1. Comparison of Rifabutin-Based Versus Rifampin-Based Regimens for Mycobacterium avium Complex Disease: Frontiers in Pharmacology, 2021.
  2. MYCOBUTIN® (rifabutin) Patient Information: Pfizer Medical Information.
  3. Rifabutin Capsules, USP: FDA Label.
  4. Randomised Pharmacokinetic Trial of Rifabutin with Lopinavir/Ritonavir in Patients with HIV-Associated Tuberculosis: PLOS ONE.
  5. Should Rifabutin Be Included in Clinical Trials for Adjunctive Therapy of Diabetic Foot Osteomyelitis?: Open Forum Infectious Diseases.

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