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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR ATOVAQUONE

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Clinical Trials for Atovaquone

Trial ID Title Status Sponsor Phase Summary
NCT00000655 A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients Completed Glaxo Wellcome Phase 2 To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP. Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.
NCT00000655 A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP. Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.
NCT00000773 Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94 amendment, a third dose level was added) daily for 12 days in HIV-infected and perinatally exposed (per 8/9/95 amendment) infants and children who are at risk of developing Pneumocystis carinii pneumonia (PCP). Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has been prepared as a microparticulate suspension. Since studies in adults have demonstrated substantial safety of this drug, evaluation in children is being pursued.
NCT00000794 Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 To evaluate the efficacy, safety, and tolerance of atovaquone with either pyrimethamine or sulfadiazine in AIDS patients with toxoplasmic encephalitis. AIDS patients with toxoplasmic encephalitis who receive the standard therapy combination of sulfadiazine and pyrimethamine experience a high frequency of severe toxicity. Atovaquone, an antibiotic that has demonstrated efficacy against toxoplasmosis in animal models and in preclinical testing has been well tolerated, is now available as a suspension, which is more readily absorbed than the tablet form of the drug. The efficacy and safety of atovaquone in combination with sulfadiazine or pyrimethamine will be studied.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Atovaquone

Condition Name

Condition Name for Atovaquone
Intervention Trials
Malaria 11
HIV Infections 11
Pneumonia, Pneumocystis Carinii 8
Falciparum 2
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Condition MeSH

Condition MeSH for Atovaquone
Intervention Trials
Malaria 16
HIV Infections 11
Pneumonia, Pneumocystis 9
Pneumonia 9
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Clinical Trial Locations for Atovaquone

Trials by Country

Trials by Country for Atovaquone
Location Trials
United States 102
Canada 7
Netherlands 6
Thailand 3
Puerto Rico 3
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Trials by US State

Trials by US State for Atovaquone
Location Trials
Maryland 8
North Carolina 7
New York 7
California 7
Tennessee 6
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Clinical Trial Progress for Atovaquone

Clinical Trial Phase

Clinical Trial Phase for Atovaquone
Clinical Trial Phase Trials
Phase 4 9
Phase 3 5
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Atovaquone
Clinical Trial Phase Trials
Completed 23
Recruiting 5
Terminated 3
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Clinical Trial Sponsors for Atovaquone

Sponsor Name

Sponsor Name for Atovaquone
Sponsor Trials
Glaxo Wellcome 7
National Institute of Allergy and Infectious Diseases (NIAID) 6
Radboud University 3
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Sponsor Type

Sponsor Type for Atovaquone
Sponsor Trials
Other 32
Industry 16
NIH 9
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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
UBS
Farmers Insurance
US Army
Daiichi Sankyo
Teva
Healthtrust
Accenture
Baxter

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