Toxoplasmosis: 566C80 Study Opens in Seven Cities

A pilot study of the experimental compound 566C80 in patients with toxoplasmosis who have failed or who are intolerant to standard therapy has recently opened at eight sites in seven U. S. cities (see list below). 566C80 has wide spectrum anti- protozoal activity, and is being tested against pneumocystis as well as against toxoplasmosis. (For more information about the drug, see "Pneumocystis Prophylaxis Overview," AIDS TREATMENT NEWS #114, November 2, 1990.) This article is based on our interview with the study coordinator at San Francisco General Hospital; we have not called the other sites.

According to SFGH research coordinator Rebecca Coleman, Pharm. D., this trial is essentially a mechanism for compassionate access for people who have failed standard treatment with pyrimethamine and sulfadiazine. Dr. Coleman stated that each patient will be considered individually under the inclusion and exclusion criteria, especially concerning presence of other active infections requiring medication.

566C80 is an oral drug; it will be administered for a total of 42 days. The study requires all patients to be hospitalized for at least four days; then they will be followed as outpatients weekly for two weeks, every two weeks for a month, and then monthly for a total of six months. Patients who respond to treatment may be eligible to receive maintenance doses of 566C80 indefinitely. According to Dr. Coleman, the company is committed to ongoing access but has not yet received FDA approval for such a program. She explained that the FDA is expected to grant incremental approvals -- perhaps for several months at a time -- to supply the drug when necessary, after the conclusion of the study.

To be eligible for the trial, patients must have a positive diagnosis of toxoplasmosis and no evidence of any other infection or cancer of brain tissue. Patients who appear to have failed standard treatment will be required to have a brain biopsy. Symptoms of toxoplasmosis must not have improved after at least 21 days of standard therapy, or must have progressed after at least 14 days of treatment. Patients intolerant to standard therapy may also qualify for this trial. They will not be required to have a brain biopsy if other diagnostic tests suggest toxoplasmosis.

Patients must be at least 13 years old, and women must have a negative pregnancy test. During the first three weeks of treatment, neither AZT, ddI, ddC, Bactrim, dapsone, clindamycin, nor any experimental treatment will be allowed.

The drug will be provided by Burroughs-Wellcome, but all other costs will be the responsibility of the patient. To facilitate reimbursement by third party payers, the diagnostic tests and frequency of clinic visits have been established to reflect standard care practices. The staff at SFGH will work with each patient and referring physician to receive prior authorization of coverage from third party payers.

Trial Sites and Physicians

Physicians with a patient to enroll should contact one of the following physicians. According to a representative of Burroughs-Wellcome, these sites are open; however, we were unable to call by press time to confirm that each is ready. Additional sites are expected to open in the future. This trial is not yet listed with the AIDS Clinical Trials Information Service (800/TRIALS-A).

San Francisco (2 sites): San Francisco General Hospital, John Stansell, M. D., 415/821-8313; Ralph K. Davies Hospital, Gifford Leong, M. D.

Oakland: Merritt-Peralta Medical Center, Patrick Joseph, M. D.

Los Angeles: Los Angeles County/USC Medical Center, Fred Sattler, M. D.

Portland: Oregon AIDS Task Force/Research and Education Group, Jim Sampson, M. D.

New York: Harlem Hospital, Wafaa El Sadr, M. D.

Baltimore: Johns Hopkins Hospital, Judith Feinberg, M. D.

Durham: Duke University Medical Center, Hetty Waskin, M. D.