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| Sponsor: | Isis Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002355 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Fomivirsen sodium |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Randomized Comparison of Immediate Versus Delayed Treatment With Intravitreal Injections of ISIS 2922 in Patients With Peripheral Cytomegalovirus (CMV) Retinitis |
| Estimated Enrollment: | 60 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions in the eye to be treated are excluded:
Patients with the following other symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Contacts and Locations| United States, California | |
| Santa Clara Valley Med Ctr | |
| San Jose, California, United States, 95128 | |
| Community Eye Med Group | |
| Pasadena, California, United States, 911052536 | |
| Retina - Vitreous Associates Med Group | |
| Los Angeles, California, United States, 90017 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| 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 | |
| United States, Indiana | |
| Indiana Univ Med Ctr | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, New York | |
| 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 | |
| United States, Texas | |
| Univ of Texas Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 752359057 | |
| United States, Virginia | |
| Virginia Eye Consultants | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Novum Inc | |
| Seattle, Washington, United States, 98104 | |
More Information
| Study ID Numbers: | 251A, ISIS 2922-CS2 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002355 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome Antiviral Agents Cytomegalovirus Retinitis |
|
Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Retinitis Infection Therapeutic Uses Cytomegalovirus Infections Retroviridae Infections Retinal Diseases RNA Virus Infections Immune System Diseases Eye Infections, Viral Eye Diseases |
Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Eye Infections Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Herpesviridae Infections Fomivirsen Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections |