CLINICAL TRIALS PROFILE FOR SULFADIAZINE

All Clinical Trials for Sulfadiazine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000666 ↗	A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate pyrimethamine as a prophylactic agent against toxoplasmic encephalitis in individuals who are coinfected with HIV and latent Toxoplasma gondii. Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients. Standard treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine. Continuous treatment is necessary to prevent recurrence of the disease, but constant use of pyrimethamine/sulfadiazine is associated with toxicity. Clindamycin has been shown to be effective in treatment of toxoplasmic encephalitis in animal studies. This study evaluates pyrimethamine as a preventive treatment against toxoplasmic encephalitis (per 3/26/91 amendment, clindamycin arm was discontinued).
NCT00000674 ↗	A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS	Completed	Glaxo Wellcome	N/A	1969-12-31	To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most frequent cause of focal central nervous system infection in patients with AIDS. If untreated, the encephalitis is fatal. At present, it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult. There is some information that high doses of parenteral (such as by injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however, is costly, requires hospitalization, and is inconvenient for the patient. There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective. Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity.
NCT00000674 ↗	A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS	Completed	Upjohn	N/A	1969-12-31	To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most frequent cause of focal central nervous system infection in patients with AIDS. If untreated, the encephalitis is fatal. At present, it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult. There is some information that high doses of parenteral (such as by injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however, is costly, requires hospitalization, and is inconvenient for the patient. There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective. Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity.

Clinical Trial Conditions for Sulfadiazine

Condition Name

Condition Name for Sulfadiazine
Intervention	Trials
HIV Infections	6
Burns	5
Toxoplasmosis, Cerebral	5

Condition MeSH

Condition MeSH for Sulfadiazine
Intervention	Trials
Burns	11
Toxoplasmosis	8
HIV Infections	6

Clinical Trial Locations for Sulfadiazine

Trials by Country

Trials by Country for Sulfadiazine
Location	Trials
United States	52
China	6
Canada	5
Brazil	3
France	2

Trials by US State

Trials by US State for Sulfadiazine
Location	Trials
California	5
New York	5
Maryland	4
Virginia	4
Illinois	4

Clinical Trial Progress for Sulfadiazine

Clinical Trial Phase

Clinical Trial Phase for Sulfadiazine
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Sulfadiazine
Clinical Trial Phase	Trials
Completed	20
Unknown status	4
Recruiting	1

Clinical Trial Sponsors for Sulfadiazine

Sponsor Name

Sponsor Name for Sulfadiazine
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	5
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara	3
Glaxo Wellcome	3

Sponsor Type

Sponsor Type for Sulfadiazine
Sponsor	Trials
Other	23
Industry	8
NIH	6