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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR CLOFAZIMINE

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Clinical Trials for Clofazimine

Trial ID Title Status Sponsor Phase Summary
NCT00000641 A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals. Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 To compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. [Per 03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with either ethambutol or clofazimine as maintenance therapy.] Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because it must be administered parenterally (by injection or intravenously).
NCT00000796 A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRT Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per 9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain. Among TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion.
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 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 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.
NCT00002058 A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease Completed University of California, San Francisco N/A This study will examine the effectiveness of clofazimine in the prophylaxis of Mycobacterium avium complex infection in HIV infected individuals who are at risk to develop this untreatable opportunistic disease. In the absence of truly effective antiretroviral therapy, a potential mode of treatment of patients with HIV infection is to prevent the development of the life-threatening opportunistic infections. Current studies demonstrate a possible efficacy of clofazimine in the prophylaxis against Pneumocystis carinii pneumonia (PCP), the most common AIDS-defining opportunistic infection. Future studies will examine the potential for prophylaxis against the other opportunistic infections. This proposal hopes to define the role of prophylactic clofazimine in preventing the currently untreatable Mycobacterium avium complex infection. AMENDED: To include prophylaxis for Asymptomatic and ARC.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Clofazimine

Condition Name

Condition Name for Clofazimine
Intervention Trials
HIV Infections 6
Mycobacterium Avium-intracellulare Infection 4
Leprosy 3
Tuberculosis, Pulmonary 2
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Condition MeSH

Condition MeSH for Clofazimine
Intervention Trials
Tuberculosis 10
Mycobacterium Infections 7
Mycobacterium avium-intracellulare Infection 7
HIV Infections 6
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Clinical Trial Locations for Clofazimine

Trials by Country

Trials by Country for Clofazimine
Location Trials
United States 60
China 9
Philippines 2
Brazil 2
Lesotho 1
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Trials by US State

Trials by US State for Clofazimine
Location Trials
California 6
New York 5
Illinois 4
Pennsylvania 4
Maryland 4
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Clinical Trial Progress for Clofazimine

Clinical Trial Phase

Clinical Trial Phase for Clofazimine
Clinical Trial Phase Trials
Phase 4 4
Phase 3 6
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Clofazimine
Clinical Trial Phase Trials
Completed 9
Not yet recruiting 5
Recruiting 3
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Clinical Trial Sponsors for Clofazimine

Sponsor Name

Sponsor Name for Clofazimine
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 5
Medecins Sans Frontieres, Netherlands 2
University College, London 2
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Sponsor Type

Sponsor Type for Clofazimine
Sponsor Trials
Other 56
NIH 6
Industry 5
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Serving hundreds of leading biopharmaceutical companies globally:

Merck
McKesson
Cipla
Fish and Richardson
Cerilliant
Daiichi Sankyo
Express Scripts
Argus Health
Dow

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