To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.
In Stage 1, up to 30 patients are randomized to either observation with deferral of treatment until the retinitis progresses (observation group), or to intravenous HPMPC at the higher dose for two consecutive weekly induction doses, followed by the lower dose every other week for maintenance. In Stage 2, up to 70 patients are randomized to observation or to HPMPC at the higher dose for two consecutive weekly induction doses followed by either dose every other week for maintenance, for a total of three treatment groups. Concomitant saline hydration and probenecid are administered to patients receiving HPMPC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
100
UCSD - Shiley Eye Ctr / SOCA
La Jolla, California, United States
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, California, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, United States
Northwestern Univ / SOCA
Chicago, Illinois, United States
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Johns Hopkins Hosp / SOCA
Baltimore, Maryland, United States
New York Univ Med Ctr / SOCA
New York, New York, United States
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, United States