NCT00004794

Phase II Randomized Study of Cidofovir for Peripheral Cytomegalovirus Retinitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 13 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cytomegalovirus Retinitis
• Acquired Immunodeficiency Syndrome

Interventions

Type	Name	Description
DRUG	cidofovir

Timeline

• Start date: 1995-03-01
• First posted: 2000-02-25
• Last updated: 2005-06-24