Full Text View
Tabular View
No Study Results Posted
Related Studies
The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Gilead Sciences
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002437
  Purpose

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 Intervention Phase
Cytomegalovirus Retinitis
HIV Infections
Drug: Cidofovir
Drug: Probenecid
Phase II

Study Type: Interventional
Study Design: Treatment, Safety Study
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 48
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.

  Eligibility

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

Inclusion Criteria

Concurrent Medication:

Allowed:

  • 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:

Allowed:

  • 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:

Excluded:

  • 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:

Excluded:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002437

Locations
United States, California
UCI Med Ctr
Orange, California, United States, 92668
Mount Zion Med Ctr
San Francisco, California, United States, 94115
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
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
  More Information

Publications:
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

Study ID Numbers: 216A, GS-93-106
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002437     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis
Probenecid
Drug Therapy, Combination
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Antiviral Agents
cidofovir

Study placed in the following topic categories:
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Retinitis
Cytomegalovirus
Anti-Retroviral Agents
Cytomegalic Inclusion Disease
Probenecid
Cytomegalovirus Infections
Retroviridae Infections
Retinal Diseases
Cidofovir
Anti-HIV Agents
Eye Diseases
Cytomegalovirus Retinitis
Acquired Immunodeficiency Syndrome
Eye Infections
Antiviral Agents
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Radiation-Sensitizing Agents
HIV Infections
Sexually Transmitted Diseases
DNA Virus Infections
Antirheumatic Agents

Additional relevant MeSH terms:
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Retinitis
Renal Agents
Infection
Gout Suppressants
Anti-Retroviral Agents
Therapeutic Uses
Probenecid
Cytomegalovirus Infections
Retroviridae Infections
Retinal Diseases
Cidofovir
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Eye Infections, Viral
Eye Diseases
Cytomegalovirus Retinitis
Acquired Immunodeficiency Syndrome
Eye Infections
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 02, 2009