Phase II Randomized Study of Cidofovir for Peripheral Cytomegalovirus Retinitis

NCT00004794 | Completed Phase 2

• 2 other identifiers: 199/11927NU-506
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cytomegalovirus Retinitis; Acquired Immunodeficiency Syndrome

Keywords

cytomegalovirus retinitis; ophthalmologic disorders; rare disease

Interventions

cidofovir DRUG

Eligibility Criteria

• Age: 13 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• Northwestern University: collaborator

MeSH Terms

Conditions

Cytomegalovirus Retinitis; Acquired Immunodeficiency Syndrome; Rare Diseases

Interventions

Cidofovir

Condition Hierarchy (Ancestors)

Eye Infections, Viral; Eye Infections; Infections; Cytomegalovirus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Eye Diseases; Retinitis; Retinal Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Cytosine; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David V. Weinberg

  Northwestern University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: March 1, 1995
• Last Updated: June 24, 2005

Record last verified: 1998-01