A Phase I Open-Labeled Study of Long Term Combined or Alternating Foscarnet/Ganciclovir Maintenance Therapy for AIDS Patients With CMV Retinitis After Ganciclovir Induction Therapy
Sight-threatening CMV retinitis occurs in at least 6 percent of AIDS patients. By 1991 (US),
there may be 6000 to 10000 patients with CMV retinitis. Many clinical reports suggest that
both ganciclovir (DHPG) and foscarnet have an antiviral effect against CMV that is often
associated with clinical stabilization. Effectiveness of ganciclovir and foscarnet is
correlated with weekly maintenance and since toxicity is dose-limiting in up to 20 percent
of patients receiving either drug for long periods, it may be beneficial in long-term
maintenance treatment to combine or alternate these two drugs at a lower total weekly dose
of each drug.
This strategy may result in a greater net antiviral effect with less toxicity than is seen
with either drug alone, because the toxicities of each drug are quite different.
All patients have newly diagnosed CMV retinitis and have completed a 14-day course of
intravenous ganciclovir or foscarnet induction therapy within 1 week prior to study entry.
The maintenance period consists of a 12-week study period followed by a 40 week follow-up
period. Treatment consists of either combined sequential daily maintenance therapy of both
foscarnet and ganciclovir or alternating daily treatment with ganciclovir one day and
foscarnet the following day.
Primary Purpose: Treatment
United States: Federal Government
|USC CRS||Los Angeles, California 90033|
|Ucsf Aids Crs||San Francisco, California|
|Washington U CRS||St. Louis, Missouri|
|Memorial Sloan-Kettering Cancer Ctr.||New York, New York 10021|
|Unc Aids Crs||Chapel Hill, North Carolina 27599|
|University of Washington AIDS CRS||Seattle, Washington 98122|