Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis
3 other identifiers
interventional
100
1 country
16
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
April 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 28, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
USC CRS
Los Angeles, California, 900331079, United States
Univ. of Miami AIDS CRS
Miami, Florida, 331361013, United States
Queens Med. Ctr.
Honolulu, Hawaii, 96816, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 462025250, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, 46202, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287, United States
Washington U CRS
St Louis, Missouri, 63110, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 13210, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10003, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, 452670405, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 432101228, United States
Related Publications (1)
Chirgwin K, Hafner R, Leport C, Remington J, Andersen J, Bosler EM, Roque C, Rajicic N, McAuliffe V, Morlat P, Jayaweera DT, Vilde JL, Luft BJ. Randomized phase II trial of atovaquone with pyrimethamine or sulfadiazine for treatment of toxoplasmic encephalitis in patients with acquired immunodeficiency syndrome: ACTG 237/ANRS 039 Study. AIDS Clinical Trials Group 237/Agence Nationale de Recherche sur le SIDA, Essai 039. Clin Infect Dis. 2002 May 1;34(9):1243-50. doi: 10.1086/339551.
PMID: 11941551BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Luft B
- STUDY CHAIR
Chirgwin K
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
April 1, 1998
Last Updated
October 28, 2021
Record last verified: 2021-10