A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis

Ionis Pharmaceuticals logo

Ionis Pharmaceuticals

Status

Completed

Conditions

Cytomegalovirus Retinitis
HIV Infections

Treatments

Drug: Fomivirsen sodium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002187
ISIS 2922-CS9
251D

Details and patient eligibility

About

The purpose of this study is to compare the safety and effectiveness of two dosage schedules for ISIS 2922 in the treatment of advanced cytomegalovirus (CMV) retinitis

Full description

This is a multicenter, prospective, randomized, open-label study comparing 2 dosage schedules of ISIS 2922.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Oral ganciclovir.
  • Leukocyte growth factors (GM-CSF and G-CSF) for patients with febrile neutropenia.

Patients must have:

  • Documented AIDS.
  • Clinical diagnosis of advanced CMV retinitis in 1 or both eyes.
  • >= 2 previous induction courses with anti-CMV retinitis therapy licensed by a regulatory agency.
  • > 25% retinal involvement with CMV retinitis.
  • Baseline CMV retinitis lesions which have leading edges > 1000 micrograms from the macula or optic disk.

Prior Medication:

Required:

  • >= 2 previous induction courses with anti-CMV retinitis therapy licensed by a regulatory agency.

Allowed:

  • All anti-CMV therapies other than ganciclovir must be discontinued no less than 2 days prior to entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • External ocular infection in the eye to be treated.
  • Other herpetic infections of the retina, toxoplasma, retinochoroiditis, or other disease of the fundus that would preclude assessment of CMV retinitis in the eye to be treated.
  • Ocular conditions that will obstruct visualization of the posterior ocular structures on the eye to be treated.
  • Retinal detachment in the eye to be treated.
  • Ganciclovir implant in the eye to be treated.
  • Known or suspected allergy to phosphorothioate oligonucleotides or intolerance of ISIS 2922.
  • Silicone oil in the eye to be treated.
  • Pseudoretinitis pigmentosa.
  • Syphilis.

Patients with the following prior conditions are excluded:

  • History of surgery to correct retinal detachment in the eye to be treated.

  • History of syphilis.

    1. Systemic anti-CMV therapies other than oral ganciclovir.
  • Mellaril, Stelazine, chlorpromazine and clofazimine.

  • Combination use of ethambutol and fluconazole.

  • Investigational medications and/or procedures for the treatment of CMV retinitis in the eye to be treated.

  • Ganciclovir implant delivery device in the eye to be treated.

  • Ganciclovir other than oral.

  • Foscarnet.

Trial contacts and locations

17

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems