AIDS TREATMENT NEWS No. 068 - November 4, 1988
John S. James
This randomized trial includes three arms: foscarnet alone, AZT alone, and foscarnet plus AZT. To avoid eye damage to persons in the control group receiving AZT alone, the study's entry criteria specify that the CMV lesion is located where it does not threaten sight, and the study will be stopped before vision is endangered. After the study, all patients will be eligible to continue foscarnet on compassionate use.
The study will take place at the National Institutes of Health in Bethesda, MD, near Washington, D. C. All expenses are paid, including travel and lodging for patients from outside the area.
Patients will need to spend 3-4 weeks at the National Eye Institute in Bethesda, followed by weekly visits. The number of visits depends on the course of the disease. During this phase of the study, patients may return home or remain in Bethesda, and NIH will pay all travel or lodging expenses, either way. Afterwards, patients can be treated with foscarnet through their home physician, making further visits to Bethesda unnecessary.
So that patients and their ophthalmologists can quickly determine whether they are eligible, we quote the inclusion and exclusion criteria.
Inclusion criteria: "Patients with AIDS (age 18-60) and cytomegalovirus retinitis located more than 3000 microns from the fovea and more than 1500 microns from the optic disc unless the vision is less than 20/400 in that eye in which case any location is eligible. One or both eyes may be involved by the retinitis.
"Serum creatine less than 2.0 mg/dl; total neutrophil count greater than 1000/mm3; total hemoglobin greater than 8 gm/dl; platelets greater than 25,000/mm3."
Exclusion criteria: "Previous therapy with ganciclovir or foscarnet. Concomitant therapy with marrow toxic or nephrotoxic agents excluding AZT. Concomitant therapy with oral or intravenous acyclovir. A history of intolerance to AZT. "
For more information, call Judith Rubin, M. D. at 301/496- 1243.
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