Clinical trial NCT00002156: A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
Official title: A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Ganciclovir
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Antiviral Agents
Cytomegalovirus Retinitis
Injections
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the clinically safe and effective dose of intravitreal ISIS 2922 alone and as an additive antiviral therapy to ganciclovir in AIDS patients with cytomegalovirus (CMV) retinitis.

Detailed description: In Stage 1 of the study, 20 patients receive one of two doses of ISIS 2922 on days 1, 8, and 15 (Induction) then every 14 days (maintenance), with ganciclovir given daily during both Induction and Maintenance. Escalation to the second dose does not occur until all patients at the first dose level have reached their first maintenance dose (day 29). In Stage 2 of the study, 174 patients are randomized to receive either a) ISIS 2922 at the dose established in Stage 1 on days 1, 8, and 15 and then every 14 days, with ganciclovir given daily during both Induction and Maintenance, or b) ganciclovir daily for 14 consecutive days and then a lower dose as maintenance. Patients may continue to receive ISIS 2922 biweekly if the dose is safe and their CMV retinitis is clinically controlled. Per 2/8/96 amendment, patients are now in Stage 2 at 150 mcg.

Eligibility criteria: Inclusion Criteria

Patients must have:

* AIDS.
* CMV retinitis that is not adequately controlled (previously diagnosed patients with smoldering CMV retinitis or those with active CMV retinitis borders on indirect ophthalmoscopy).
* No more than one previous progression of CMV retinitis.

Exclusion Criteria

Co-existing Condition:

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

* External ocular infection.
* Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.
* Ocular condition 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.
* Retinal pigment epithelial stippling not associated with CMV retinitis.
* Pseudoretinitis pigmentosa.
* Chronic diarrhea that would impair absorption of oral ganciclovir.
* Intolerance to ganciclovir.

Concurrent Medication:

Excluded:

* Foscarnet or other anti-CMV agents other than ganciclovir.
* 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 eye to be treated.
* History of intolerance to ISIS 2922.

Prior Medication:

Excluded:

* Prior ganciclovir implant for CMV retinitis.
* More than 4 months of prior ganciclovir.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
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: Fort Lauderdale
country: United States
facility: Dr Julio Perez
state: Florida
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 York
country: United States
facility: Vitreo - Retinal Consultants
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose and Throat Association
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: 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: