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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002156
Other study ID # 251B
Secondary ID ISIS 2922-CS3
Status Completed
Phase Phase 2
First received November 2, 1999
Last updated June 23, 2005

Study information

Verified date December 1998
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 194
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Fomivirsen sodium

Ganciclovir


Locations

Country Name City State
United States Georgia Retina Atlanta Georgia
United States Charlotte Eye Ear Nose and Throat Association Charlotte North Carolina
United States Univ of Illinois Chicago Illinois
United States Univ of Texas Southwestern Med Ctr of Dallas Dallas Texas
United States Univ of Colorado Health Sciences Ctr Denver Colorado
United States Dr Julio Perez Fort Lauderdale Florida
United States Baylor College of Medicine Houston Texas
United States Indiana Univ Med Ctr Indianapolis Indiana
United States Retina - Vitreous Associates Med Group Los Angeles California
United States Vitreo - Retinal Consultants New York New York
United States Virginia Eye Consultants Norfolk Virginia
United States Community Eye Med Group Pasadena California
United States Graduate Hosp Philadelphia Pennsylvania
United States Hahnemann Univ Hosp Philadelphia Pennsylvania
United States San Diego Naval Hosp San Diego California
United States Univ of California San Francisco / SF Gen Hosp San Francisco California
United States Santa Clara Valley Med Ctr San Jose California
United States Novum Inc Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Ionis Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

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