A Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus (CMV) of the Eyes

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002355
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1998

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002355 on ClinicalTrials.gov Archive Site
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A Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus (CMV) of the Eyes
A Randomized Comparison of Immediate Versus Delayed Treatment With Intravitreal Injections of ISIS 2922 in Patients With Peripheral Cytomegalovirus (CMV) Retinitis

To determine a clinically safe and effective dose of intravitreally injected ISIS 2922 and to compare the safety and efficacy of immediate versus delayed treatment in AIDS patients with previously untreated, peripheral cytomegalovirus ( CMV ) retinitis.

In Stage 1 (dose escalation), patients receive either 75 or 150 mcg intravitreal ISIS 2922. In Stage 2 (randomization), patients are enrolled in either the immediate treatment group or delayed treatment group. Immediate treatment consists of intravitreal ISIS 2922 every 7 days for 3 injections (Induction) then every 14 days for 18 weeks (Maintenance). Patients in the delayed treatment group receive no immediate anti-CMV treatment but are monitored weekly for disease progression. If disease progresses, patient receives ISIS 2922 on an identical dosage regimen as those on immediate treatment. Patients may continue ISIS 2922 on a biweekly extended maintenance schedule if dose is considered safe and the CMV retinitis is clinically controlled. Per 2/8/96 amendment, patients are now in Stage 2 at 150 mcg.

Interventional
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Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
Drug: Fomivirsen sodium
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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Inclusion Criteria

Patients must have:

  • AIDS.
  • Clinical diagnosis of previously untreated peripheral CMV retinitis in one eye.
  • Leading edge of a CMV retinitis lesion is at least 750 microns from zone one. NOTE:
  • Patients with CMV retinitis in zone three only may be eligible if the lesions can be reliably photographed to follow progression.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions in the eye to be treated are excluded:

  • External ocular infections.
  • Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.
  • Ocular conditions that will obstruct visualization of the posterior ocular structures.
  • Retinal detachment.
  • Silicone oil in eye.

Patients with the following other symptoms or conditions are excluded:

  • Known or suspected allergy to phosphorothioate oligonucleotides.
  • Syphilis.
  • Pseudoretinitis pigmentosa.

Concurrent Medication:

Excluded:

  • Current treatment for extra-ocular CMV infection.
  • Ganciclovir.
  • Foscarnet.
  • Mellaril.
  • Stelazine.
  • Thorazine.
  • Clofazimine.
  • Ethambutol/fluconazole combination.
  • Investigational medications for CMV retinitis.

Concurrent Treatment:

Excluded:

  • Investigational procedures for CMV retinitis.

Patients with the following prior conditions are excluded:

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

Prior Medication:

Excluded:

  • Prior anti-CMV retinitis treatment in either eye.
  • Anti-CMV therapy for extra-ocular infection within the past 2 days.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002355
251A, ISIS 2922-CS2
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Isis Pharmaceuticals
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NIH AIDS Clinical Trials Information Service
July 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP