Acquired Immunodeficiency Syndrome Clinical Trial
Verified date | January 1998 |
Source | Office of Rare Diseases (ORD) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 13 Years to 60 Years |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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National Center for Research Resources (NCRR) | Northwestern University |
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