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Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis Clinical research trials and Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis. Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis  Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis
Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis
For Condition: Toxoplasmosis, Cerebral,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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. Seventy patients are randomized to receive atovaquone with either pyrimethamine or sulfonamides for up to 48 weeks. Additionally, three cohorts of 10 patients each who have a history of treatment-limiting toxicity to pyrimethamine, sulfadiazine, or both drugs receive atovaquone plus the alternate drug or atovaquone plus clarithromycin. All patients receiving pyrimethamine also receive leucovorin protection. PER AMENDMENT 4/3/96: The open treatment groups are: Atovaquone plus pyrimethamine for patients with acute toxoplasmic encephalitis who have no treatment limiting toxicity to pyrimethamine, and Atovaquone plus clarithromycin for patients with acute toxoplasmic encephalitis who have treatment limiting toxicity to both pyrimethamine and sulfadiazine. The following arms closed on 12/22/95: Randomization to the atovaquone plus sulfadiazine arm for patients with acute toxoplasmic encephalitis who had no treatment limiting toxicity to pyrimethamine or sulfonamides, and Atovaquone plus sulfadiazine for patients with acute toxoplasmic encephalitis who had treatment limiting toxicity to pyrimethamine. The following arm closed on 9/26/95: Atovaquone plus pyrimethamine for patients with acute toxoplasmic encephalitis who had treatment limiting toxicity to sulfonamides. NOTE: Any patients enrolled in previous versions will continue to be treated with that same drug treatment and followed under their previous version guidelines.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Aerosolized pentamidine for PCP prophylaxis. PER AMENDMENT 4/3/96: - History of treatment limiting toxicity to pyrimethamine. Patients with a history of treatment limiting toxicity to both pyrimethamine and sulfonamides will be assigned to receive atovaquone plus clarithromycin. Patients must have: - Documented HIV infection or diagnosis of AIDS (except for CD4 count < 200 cells/mm3). - Toxoplasmic encephalitis. - Ability to give informed consent or legal designee who could give consent. PER AMENDMENT 4/3/96: - NOTE - A history of treatment limiting toxicity to both pyrimethamine and sulfonamides will result in the patient being enrolled in the atovaquone plus clarithromycin arm. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Coma. - Opportunistic infection that requires either acute or maintenance treatment with disallowed medications. - Any infections or neoplasms of the central nervous system other than Toxoplasma, HIV encephalopathy, or syphilis. - Unable to take oral study drugs. - Malabsorption (i.e., three or more episodes of diarrhea per day that has caused >= 10 percent loss of body weight over the past 4 weeks). - Positive CSF or serum for Cryptococcus antigen or culture (a positive serum antigen only is acceptable, provided patient received prior antifungal therapy and is on maintenance, and the likelihood of recurrence is low). - Malignancy requiring use of cytotoxic chemotherapy. - Medical or social condition that would adversely affect study participation or compliance. Concurrent Medication: Excluded: - Trimethoprim-sulfamethoxazole. - Primaquine. - Sulfonamides. - Antifolates. - Dapsone. - Clarithromycin (except for patients in the cohort to receive this drug). - Azithromycin. - Clindamycin. - Other macrolides. - Gamma interferon. - Metoclopramide. - G-CSF or GM-CSF. Excluded in patients receiving clarithromycin as study drug: - Terfenadine, astemizole, or any other long-acting, non-sedating antihistamines. PER AMENDMENT 4/3/96: - Cisapride - may increase GI motility and may increase drug absorption. Patients with the following prior conditions are excluded: - History of treatment-limiting toxicity to atovaquone. - Receipt of > 96 hours (per amendment) of treatment prior to study entry for the current episode of toxoplasmic encephalitis.
Total Enrollment: 100
Location and Contact Information:
Overall Study Official:
LuftB, Study Chair,
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Hopital Bichat - Claude Bernard
Paris, ,
France
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Hopital Pasteur
Paris, ,
France
Beth Israel Med Ctr
New York City, New York, 10003
United States
Hopital Cochin - Port Royal
Paris, ,
France
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Hopital Saint Andre
Bordeaux, ,
France
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Hosp Jean Verdier A Bondy
Bondy, ,
France
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Hopital Hotel Dieu de Lyon
Lyon, ,
France
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Additional Information:
Study ID Numbers: ACTG 237; ANRS 039
Study Start Date:
Record last reviewed: January 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000794
Other Hiv Infections Studies:
1. A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS
2. Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients
3. A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients
4. A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma gondii Infection
5. A Pilot Study of 566C80 for the Salvage Treatment of Toxoplasmic Encephalitis in Patients Infected With the Human Immunodeficiency Virus (HIV) Who Have Failed or are Intolerant of Pyrimethamine-Sulfadiazine
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Syracuse Clinical Trials
Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis
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