An Open-Label Study of the Safety and Efficacy of Cidofovir for the Treatment of Relapsing Cytomegalovirus Retinitis in Patients With AIDS

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002142
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1995
  Purpose

To evaluate the safety and tolerance of cidofovir (HPMPC) infusions in AIDS patients with relapsing cytomegalovirus (CMV) retinitis. To determine the time to retinitis progression in this patient population. To evaluate the impact of cidofovir therapy on visual acuity.


Condition Intervention
Cytomegalovirus Retinitis
HIV Infections
Drug: Cidofovir
Drug: Probenecid

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of the Safety and Efficacy of Cidofovir for the Treatment of Relapsing 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: 100
Detailed Description:

Patients are randomized to receive intravenous HPMPC either at one dose for both induction and maintenance or at a higher dose for induction than for maintenance. Induction consists of two consecutive weekly doses followed by maintenance every other week. All patients receive concomitant probenecid and saline hydration. Treatment continues until retinitis progression, as assessed by retinal photographs, or treatment-limiting toxicity occurs.

  Eligibility

Ages Eligible for Study:   13 Years and older
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).
  • Itraconazole.
  • HIV vaccines.

Patients must have:

  • AIDS.
  • CMV retinitis, with severity as specified in the Disease Status field.
  • Life expectancy of at least 3 months.
  • Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Known clinically significant allergy to probenecid.
  • Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
  • Other active medical problems sufficient to hinder study compliance.

Concurrent Medication:

Excluded:

  • Amphotericin B.
  • Aminoglycoside antibiotics.
  • Vidarabine.
  • Intravenous pentamidine.
  • CMV hyperimmune immunoglobulin.
  • Other nephrotoxic or potentially nephrotoxic agents.
  • Other investigational agents with anti-CMV activity.
  • Ganciclovir.
  • Intravenous or oral acyclovir (except following development of herpetic lesion).
  • Foscarnet.
  • Diuretics.

Prior Medication:

Excluded within 2 days prior to study entry:

  • Ganciclovir or foscarnet.

Excluded within one week prior to study entry:

  • Amphotericin B.
  • Aminoglycoside antibiotics.
  • Vidarabine.
  • Intravenous pentamidine.
  • CMV hyperimmune immunoglobulin.
  • Other nephrotoxic agents.
  • Other investigational agents with anti-CMV activity.

Excluded at any time:

Prior systemic or intravitreal HPMPC.

Drug or alcohol abuse that is considered sufficient to hinder study compliance.

  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: NCT00002142

Locations
United States, New Jersey
Besselaar Associates
Princeton, New Jersey, United States, 085406681
Sponsors and Collaborators
Gilead Sciences
  More Information

Publications:
Stagg RJ, et al. The Vistide (cidofovir injection) treatment IND for relapsing CMV retinitis (CMV-R). 4th Conf Retro and Opportun Infect. 1997 Jan 22-26;:120 (abstract no 306)

ClinicalTrials.gov Identifier: NCT00002142     History of Changes
Other Study ID Numbers: 216B, GS-93-107
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

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

ClinicalTrials.gov processed this record on August 21, 2014