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Last Updated: August 11, 2020

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CLINICAL TRIALS PROFILE FOR SULFAMETHOXAZOLE AND TRIMETHOPRIM

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505(b)(2) Clinical Trials for SULFAMETHOXAZOLE AND TRIMETHOPRIM

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT03431168 A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV Recruiting University of Alabama at Birmingham Phase 2 2018-03-07 More than 3 billion people worldwide are at risk of acquiring malaria and pregnant women living with HIV in Africa are at particular risk. An effective prophylaxis regimen capable of preventing malaria and other common perinatal infections would have great potential to improve adverse birth outcomes. The purpose of this randomized controlled trial is to evaluate a new combination prophylaxis regimen in pregnant women with HIV in Cameroon to determine its efficacy and safety.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for SULFAMETHOXAZOLE AND TRIMETHOPRIM

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000640 A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS Completed Glaxo Wellcome Phase 3 1969-12-31 To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS Completed Jacobus Pharmaceutical Phase 3 1969-12-31 To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
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 1969-12-31 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 1969-12-31 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for SULFAMETHOXAZOLE AND TRIMETHOPRIM

Condition Name

Condition Name for SULFAMETHOXAZOLE AND TRIMETHOPRIM
Intervention Trials
HIV Infections 36
Pneumonia, Pneumocystis Carinii 27
Malaria 6
Urinary Tract Infection 6
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Condition MeSH

Condition MeSH for SULFAMETHOXAZOLE AND TRIMETHOPRIM
Intervention Trials
HIV Infections 38
Pneumonia 34
Pneumonia, Pneumocystis 31
Infection 31
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Clinical Trial Locations for SULFAMETHOXAZOLE AND TRIMETHOPRIM

Trials by Country

Trials by Country for SULFAMETHOXAZOLE AND TRIMETHOPRIM
Location Trials
United States 364
Canada 10
Mexico 6
Puerto Rico 6
Netherlands 5
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Trials by US State

Trials by US State for SULFAMETHOXAZOLE AND TRIMETHOPRIM
Location Trials
California 29
New York 23
Illinois 23
Pennsylvania 17
Texas 17
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Clinical Trial Progress for SULFAMETHOXAZOLE AND TRIMETHOPRIM

Clinical Trial Phase

Clinical Trial Phase for SULFAMETHOXAZOLE AND TRIMETHOPRIM
Clinical Trial Phase Trials
Phase 4 23
Phase 3 34
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for SULFAMETHOXAZOLE AND TRIMETHOPRIM
Clinical Trial Phase Trials
Completed 75
Recruiting 23
Not yet recruiting 14
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Clinical Trial Sponsors for SULFAMETHOXAZOLE AND TRIMETHOPRIM

Sponsor Name

Sponsor Name for SULFAMETHOXAZOLE AND TRIMETHOPRIM
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 29
Glaxo Wellcome 8
M.D. Anderson Cancer Center 8
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Sponsor Type

Sponsor Type for SULFAMETHOXAZOLE AND TRIMETHOPRIM
Sponsor Trials
Other 142
NIH 50
Industry 38
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Mallinckrodt
McKesson
Harvard Business School
AstraZeneca

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