Phase II Randomized Study of Cidofovir for Peripheral Cytomegalovirus Retinitis

This study has been completed.
Sponsor:
Collaborator:
Northwestern University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004794
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: January 1998
  Purpose

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 Intervention Phase
Cytomegalovirus Retinitis
Acquired Immunodeficiency Syndrome
Drug: cidofovir
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 90
Study Start Date: March 1995
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.

  Eligibility

Ages Eligible for Study:   13 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004794

Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: David V. Weinberg Northwestern University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004794     History of Changes
Other Study ID Numbers: 199/11927, NU-506
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
cytomegalovirus retinitis
ophthalmologic disorders
rare disease

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
HIV Infections
Immunologic Deficiency Syndromes
Retinitis
Cytomegalovirus Infections
DNA Virus Infections
Eye Diseases
Eye Infections
Eye Infections, Viral
Herpesviridae Infections
Immune System Diseases
Lentivirus Infections
Retinal Diseases
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Cidofovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014