Clinical trial NCT00002356: The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes
Official title: An Open-Label Study of the Safety and Efficacy of Intravitreal ISIS 2922 in Acquired Immune Deficiency Syndrome (AIDS) Patients With Cytomegalovirus Retinitis (NOTE: Restricted to Patients Who Rollover From Another Controlled ISIS 2922 Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
Antiviral Agents
Cytomegalovirus Retinitis
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of ISIS 2922 in AIDS patients with Cytomegalovirus ( CMV ) retinitis who are unresponsive or intolerant to ganciclovir and/or foscarnet but are otherwise ineligible for ISIS Pharmaceuticals' controlled trials OR who have failed ISIS 2922 therapy on another controlled clinical trial.

PER 2/8/96 AMENDMENT: Patients must rollover from another ISIS 2922 controlled trial.

Detailed description: Patients receive intravitreal injections of ISIS 2922 at doses of either 150 or 300 mcg, depending on CMV retinitis location and extent of retinal involvement. There is a 3-week Induction period followed by at least 18 weeks of Maintenance. Induction is given on days 1, 8, and 15, and Maintenance doses are given every 14 days, beginning on day 29.

Eligibility criteria: Inclusion Criteria

Patients must have:

* AIDS.
* CMV retinitis in one or both eyes that was previously treated but is presently uncontrolled.
* Intolerance or resistance to other therapies.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Eligibility to participate in a controlled clinical trial of ISIS 2922.
* External ocular infection in eye to be treated.
* Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other diseases of the fundus in eye to be treated.
* Ocular condition that would obstruct visualization of the posterior ocular structures in eye to be treated.
* Retinal detachment in eye to be treated.
* Known or suspected allergy to phosphorothioate oligonucleotides.
* Silicone oil in eye to be treated.
* Syphilis.
* Clinical evidence of retinal pigment epithelial stippling.
* Pseudoretinitis pigmentosa.

Concurrent Medication:

Excluded:

* Foscarnet.
* Mellaril, Stelazine, Thorazine, and Clofazimine.
* Ethambutol / fluconazole combination.
* Other investigational drugs for CMV retinitis.

Patients with the following prior conditions are excluded:

* History of surgery to correct retinal detachment in eye to be treated.
* History of ganciclovir implant for treatment of CMV retinitis.
* History of intolerance to ISIS 2922.
* History of syphilis.

Required:

* Prior CMV retinitis therapy with ganciclovir, foscarnet, or ISIS 2922.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UCI College of Medicine
state: California
city: Los Angeles
country: United States
facility: Retina - Vitreous Associates Med Group
state: California
city: Pasadena
country: United States
facility: Community Eye Med Group
state: California
city: San Diego
country: United States
facility: San Diego Naval Hosp
state: California
city: San Francisco
country: United States
facility: Univ of California San Francisco / SF Gen Hosp
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Med Ctr
state: California
city: Denver
country: United States
facility: Univ of Colorado Health Sciences Ctr
state: Colorado
city: Washington
country: United States
facility: Dr Alan Palestine
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Dr Julio Perez
state: Florida
city: Miami
country: United States
facility: Bascon Palmer Eye Institute
state: Florida
city: Atlanta
country: United States
facility: Emory Univ School of Medicine / Emory Eye Ctr
state: Georgia
city: Atlanta
country: United States
facility: Georgia Retina
state: Georgia
city: Chicago
country: United States
facility: Univ of Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Univ Med Ctr
state: Indiana
city: New Orleans
country: United States
facility: Tulane Univ
state: Louisiana
city: New York
country: United States
facility: Vitreo - Retinal Consultants
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose & Throat Association
state: North Carolina
city: Durham
country: United States
facility: Duke Univ
state: North Carolina
city: Philadelphia
country: United States
facility: Hahnemann Univ Hosp
state: Pennsylvania
city: Philadelphia
country: United States
facility: Graduate Hosp
state: Pennsylvania
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Houston
country: United States
facility: Vitreoretinal Consultants
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
city: Seattle
country: United States
facility: Novum Inc
state: Washington
Study officials:
References: