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
Toxoplasmosis, Cerebral, HIV Infections
About this trial
This is an interventional treatment trial for Toxoplasmosis, Cerebral focused on measuring Toxoplasmosis, AIDS-Related Opportunistic Infections, Naphthoquinones, Encephalitis, Acquired Immunodeficiency Syndrome
Eligibility Criteria
Inclusion Criteria Patients must have the following: Presumptive diagnosis of AIDS. Cerebral toxoplasmosis. Expected survival of at least four weeks without therapy. Willing and able to give informed consent. Prior Medication: Allowed: Pyrimethamine-sulfonamide. Clindamycin-sulfonamide. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Significant emotional disorder or psychosis. Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption. Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg: Ensure Plus) or pulverized form through a nasogastric tube. Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen. Concurrent Medication: Excluded: Drugs with potential anti-toxoplasmosis activity including sulfone, sulfonamide, trimethoprim, pyrimethamine and clindamycin during the acute therapy phase of the trial. First three weeks of treatment: Retrovir (zidovudine) or any investigational agent including antiretroviral agents (eg: ddI,ddC). Patients with the following are excluded: Significant emotional disorder or psychosis. Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption. Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg: Ensure Plus) or pulverized form through a nasogastric tube. Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen. Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
Sites / Locations
- Los Angeles County - USC Med Ctr
- Infectious Disease Med Group
- San Francisco Gen Hosp
- UCSF - San Francisco Gen Hosp
- Davies Med Ctr
- Georgetown Univ Med Ctr
- Infectious Disease Research Consortium of Georgia
- Johns Hopkins Hosp
- Beth Israel Med Ctr
- Saint Vincent's Hosp and Med Ctr
- Harlem Hosp Ctr
- SUNY / Health Sciences Ctr at Stony Brook
- Duke Univ Med Ctr
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
- Regional Med Ctr at Memphis
- Gathe, Joseph, M.D.
- Baylor College of Medicine
- Infectious Disease Physicians Inc
- Southern Alberta HIV Clinic / Foothills Hosp
- Dr Julio S G Montaner
- Wellesley Hosp
- Dr Emil Toma / Hotel Dieu de Montreal