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| Sponsor: | Isis Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002187 |
Purpose
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
| Condition | Intervention |
|---|---|
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Fomivirsen sodium |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Official Title: | A Randomized Comparison of Two Dosage Schedules of Intravitreal ISIS 2922 for Patients With Advanced Cytomegalovirus Retinitis |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Required:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Patients with the following prior conditions are excluded:
History of syphilis.
1. Systemic anti-CMV therapies other than oral ganciclovir.
Contacts and Locations| United States, California | |
| Retina - Vitreous Associates Med Group | |
| Los Angeles, California, United States, 90017 | |
| Community Eye Med Group | |
| Pasadena, California, United States, 911052536 | |
| Dr Jacob Lalezari | |
| San Francisco, California, United States, 94115 | |
| Univ of California San Francisco / SF Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| United States, District of Columbia | |
| Dr Alan Palestine | |
| Washington, District of Columbia, United States, 20006 | |
| United States, Florida | |
| Dr Julio Perez | |
| Fort Lauderdale, Florida, United States, 33060 | |
| United States, Georgia | |
| Georgia Retina | |
| Atlanta, Georgia, United States, 30327 | |
| United States, Illinois | |
| Univ of Illinois | |
| Chicago, Illinois, United States, 60612 | |
| Chicago Ctr for Clinical Research | |
| Chicago, Illinois, United States, 60610 | |
| United States, Indiana | |
| Indiana Univ Med Ctr | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, New York | |
| New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Vitreo - Retinal Consultants | |
| New York, New York, United States, 10028 | |
| United States, North Carolina | |
| Charlotte Eye Ear Nose & Throat Association | |
| Charlotte, North Carolina, United States, 28204 | |
| Duke Univ | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Hahnemann Univ Hosp | |
| Philadelphia, Pennsylvania, United States, 191021192 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Novum Inc | |
| Seattle, Washington, United States, 98104 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002187 History of Changes |
| Other Study ID Numbers: | 251D, ISIS 2922-CS9 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Antiviral Agents Drug Administration Schedule |
Cytomegalovirus Retinitis fomivirsen Vitreous Body |
|
HIV Infections Acquired Immunodeficiency Syndrome Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Retinal Diseases Eye Diseases Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Eye Infections, Viral Eye Infections Fomivirsen Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |