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Phase II Randomized Study of Cidofovir for Peripheral Cytomegalovirus Retinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004794
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Northwestern University
Information provided by:
Office of Rare Diseases (ORD)

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.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Drug: cidofovir Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Primary Purpose: Treatment
Study Start Date : March 1995

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004794

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Northwestern University
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Study Chair: David V. Weinberg Northwestern University

Layout table for additonal information Identifier: NCT00004794    
Other Study ID Numbers: 199/11927
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 1998
Keywords provided by Office of Rare Diseases (ORD):
cytomegalovirus retinitis
ophthalmologic disorders
rare disease
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Cytomegalovirus Retinitis
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action