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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR CLOTRIMAZOLE

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Clinical Trials for Clotrimazole

Trial ID Title Status Sponsor Phase Summary
NCT00000676 Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081) Completed Pfizer Phase 3 To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches (lozenges) as prophylaxis (preventive treatment) against fungal infections in patients enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and serious bacterial infection). Primarily, to compare the rates of invasive infections by C. neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal infections between two antifungal prophylactic treatments. Secondarily, to assess the effect of prophylaxis on the incidence of severe fungal infections, defined as invasive infections and esophageal candidiasis and less severe mucocutaneous infection. Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis appears favorable, and studies of oropharyngeal candidiasis show it to be effective.
NCT00000676 Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081) Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches (lozenges) as prophylaxis (preventive treatment) against fungal infections in patients enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and serious bacterial infection). Primarily, to compare the rates of invasive infections by C. neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal infections between two antifungal prophylactic treatments. Secondarily, to assess the effect of prophylaxis on the incidence of severe fungal infections, defined as invasive infections and esophageal candidiasis and less severe mucocutaneous infection. Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis appears favorable, and studies of oropharyngeal candidiasis show it to be effective.
NCT00000991 A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with HIV infection and T4 cell count less than 200 cells/mm3. All persons completing at least 8 weeks of therapy on 081 will be offered the opportunity to participate in the nested study (ACTG 981) of systemic antifungal therapy (fluconazole) versus local therapy (Clotrimazole) for the prevention of serious fungal disease. Persons with HIV disease who are receiving AZT are at risk for PCP, toxoplasmosis, bacterial pneumonia, and other serious infections. It is therefore important to find drugs that can be given along with AZT to control these infections. Aerosolized pentamidine (PEN) has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP. Both sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective preventive treatment against PCP, and both may be useful in preventing toxoplasmosis and extrapulmonary pneumocystosis.
NCT00002282 A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDS Completed Pfizer N/A To compare the efficacy, safety, and tolerance of fluconazole single daily capsule for 14 days versus clotrimazole troche 5 x daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS.
NCT00004404 Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes Completed Boston Children’s Hospital N/A OBJECTIVES: Determine the effectiveness of the combined use of clotrimazole and hydroxyurea on a specific panel of red cell characteristics in patients with sickle cell syndromes.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Clotrimazole

Condition Name

Condition Name for Clotrimazole
Intervention Trials
HIV Infections 4
Candidiasis 3
Vulvovaginal Candidiasis 3
Candidiasis, Oral 2
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Condition MeSH

Condition MeSH for Clotrimazole
Intervention Trials
Candidiasis 12
Candidiasis, Vulvovaginal 5
Infection 5
HIV Infections 4
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Clinical Trial Locations for Clotrimazole

Trials by Country

Trials by Country for Clotrimazole
Location Trials
United States 60
Germany 6
Canada 4
India 4
Spain 2
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Trials by US State

Trials by US State for Clotrimazole
Location Trials
Massachusetts 5
New York 5
Pennsylvania 4
Ohio 4
North Carolina 4
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Clinical Trial Progress for Clotrimazole

Clinical Trial Phase

Clinical Trial Phase for Clotrimazole
Clinical Trial Phase Trials
Phase 4 6
Phase 3 11
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Clotrimazole
Clinical Trial Phase Trials
Completed 17
Not yet recruiting 4
Recruiting 3
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Clinical Trial Sponsors for Clotrimazole

Sponsor Name

Sponsor Name for Clotrimazole
Sponsor Trials
Ache Laboratorios Farmaceuticos S.A. 2
Medinova AG 2
National Institute of Allergy and Infectious Diseases (NIAID) 2
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Sponsor Type

Sponsor Type for Clotrimazole
Sponsor Trials
Other 21
Industry 16
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Daiichi Sankyo
Teva
Baxter
UBS
Julphar
Fish and Richardson
Dow
McKinsey

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