Phase II Randomized Study of Cidofovir for Peripheral Cytomegalovirus Retinitis

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: Northwestern University
• Treatments: Cidofovir

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Acquired immunodeficiency syndrome (AIDS) Meets Centers for Disease Control and Prevention definition

• Peripheral cytomegalovirus (CMV) retinitis Diagnosed by ophthalmologist certified by the Study of Ocular Complications of AIDS group At least 1 lesion measuring at least 25% of disc on photograph No lesion within zone 1 No lesion involving 25% or more of retina regardless of location

• Visual acuity in affected eye 3 or more lines on the Early Treatment Diabetic Retinopathy Study chart at 1 meter Snellen equivalent 8/200

• No retinal detachment in affected eye

• No media opacity that precludes visualization of fundus in both eyes

• No extraocular CMV disease

--Prior/Concurrent Therapy--

• No prior or concurrent anti-CMV therapy, i.e.: Ganciclovir Foscarnet CMV hyperimmune immunoglobulin Other investigational agents with anti-CMV activity

• Prior CMV prophylaxis allowed

• At least 7 days since nephrotoxic drugs, including: Amphotericin B Vidarabine Aminoglycoside antibiotics Intravenous pentamidine

--Patient Characteristics--

• Age: 13 to 60

• Performance status: Karnofsky 60%-100%

• Hematopoietic: ANC at least 750 Platelets at least 50,000 Hemoglobin greater than 7.5 g/dL

• Hepatic: Bilirubin no greater than 3.0 mg/dL Transaminases no greater than 5 times normal

• Renal: Creatinine no greater than 1.5 mg/dL Proteinuria less than 1+ No clinically significant renal disease No dialysis

• Cardiovascular: No clinically significant cardiac disease, including: Ischemia Congestive heart failure Arrhythmia

• Other:

No probenecid allergy No medical problems sufficient to hinder compliance with therapy or follow- up, including drug or alcohol abuse No pregnant or nursing women Negative serum pregnancy test required of fertile women Adequate birth control required of fertile patients during and for 3 months after study