Acquired Immunodeficiency Syndrome Clinical Trial
OBJECTIVES: I. Evaluate the safety and efficacy of intravenous cidofovir in patients with
small peripheral cytomegalovirus retinitis.
II. Obtain safety and efficacy data related to different dosages of cidofovir.
PROTOCOL OUTLINE: This is a randomized study. Cidofovir is administered intravenously.
Treatment ideally begins within 24 hours of randomization.
In the first group, therapy is deferred until disease progression. Patients are then treated
according to best medical judgement, which includes the option of cidofovir therapy.
The second group receives induction with cidofovir every 7 days for 2 weeks, then begins
maintenance with a low dose given every 14 days until dose-limiting toxicity or disease
progression occurs.
The third group receives the same cidofovir induction followed by a high maintenance dose
given every 14 days until dose-limiting toxicity or disease progression occurs.
Probenecid and intravenous hydration are administered concurrently with cidofovir.
Patients are followed for progression and survival every 2 weeks for 23 weeks, then every 12
weeks. At disease progression, patients may be re-treated with another course of induction
and maintenance.
;
Primary Purpose: Treatment
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