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The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

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: NCT00002437
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
To determine whether cidofovir (HPMPC) therapy administered by intravenous infusion can extend the time to progression of peripheral cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the safety and tolerance of HPMPC therapy when administered by intravenous infusion in AIDS patients with CMV retinitis that is not immediately sight-threatening. To evaluate the virologic effects of intravenous HPMPC therapy on CMV shedding in urine, blood, and/or semen. To evaluate the impact of HPMPC therapy on visual acuity.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Retinitis HIV Infections Drug: Cidofovir Drug: Probenecid Phase 2

Detailed Description:
Patients are randomized to one of two treatment arms. Group A receives HPMPC by IV infusion weekly for 2 consecutive weeks (induction) and then every other week (maintenance) with oral probenecid and IV hydration. Group B receives no treatment until the time of retinitis progression (deferred treatment), at which time they receive the same regimen as Group A, provided retinitis progression is not immediately sight-threatening.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 48 participants
Primary Purpose: Treatment
Official Title: A Phase II/III Study of the Safety and Efficacy of 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) for the Treatment of Peripheral Cytomegalovirus Retinitis in Patients With AIDS

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

Inclusion Criteria

Concurrent Medication:


  • Antiretroviral agents.
  • Oral trimethoprim/sulfamethoxazole.
  • Aerosolized pentamidine.
  • Dapsone.
  • Fluconazole.
  • Rifabutin.
  • Filgrastim (G-CSF).
  • p24 vaccine.

Patients must have:

  • Diagnosis of AIDS by CDC criteria.
  • Diagnosis of peripheral (not immediately sight-threatening) CMV retinitis.
  • Visual acuity in the affected eye of >= three lines on the ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 1 m distance.
  • Life expectancy of at least 3 months.
  • Consent of parent or guardian in patients less than 18 years of age.

Prior Medication:


  • Acyclovir.
  • Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin if given solely as prophylaxis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Media opacity that precludes visualization of the fundus of both eyes.
  • Retinal detachment.
  • Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
  • Active medical problems considered sufficient to hinder study compliance.
  • Known clinically significant allergy to probenecid.

Concurrent Medication:


  • Acyclovir (may be reinstituted following development of herpetic lesions).
  • Ganciclovir.
  • Foscarnet.
  • Amphotericin B.
  • Diuretics.
  • Aminoglycoside antibiotics.
  • CMV hyperimmune immunoglobulin.
  • Intravenous pentamidine.
  • Other nephrotoxic agents.
  • Other investigational drugs with potential nephrotoxicity.

Prior Medication:


  • Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin as therapy for CMV disease (although permitted if previously received solely as prophylaxis).

Excluded within 1 week prior to study entry:

  • Amphotericin B.
  • Vidarabine.
  • Other nephrotoxic agents.
  • Aminoglycoside antibiotics.
  • Intravenous pentamidine. Drug or alcohol abuse.

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): NCT00002437

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United States, California
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
UCI Med Ctr
Orange, California, United States, 92668
Mount Zion Med Ctr
San Francisco, California, United States, 94115
United States, Massachusetts
Beth Israel Hosp
Boston, Massachusetts, United States, 02215
United States, New Jersey
Besselaar Associates
Princeton, New Jersey, United States, 085406681
United States, New York
Univ of Rochester Med Ctr
Rochester, New York, United States, 14607
United States, North Carolina
Univ of North Carolina Hosps
Chapel Hill, North Carolina, United States, 27599
United States, Texas
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States, 78284
United Kingdom
Charing Cross and Westminster Med School
London SW 10, United Kingdom
Sponsors and Collaborators
Gilead Sciences

Lalezari J, et al. A phase II/III randomized study of immediate versus deferred intravenous (IV) cidofovir (CDV, HPMPC) for the treatment of peripheral CMV retinitis (CMV-R) in patients with AIDS. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:170

Layout table for additonal information Identifier: NCT00002437     History of Changes
Other Study ID Numbers: 216A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 1994
Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Antiviral Agents
Additional relevant MeSH terms:
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Cytomegalovirus Retinitis
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
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents