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Sponsored by: |
Isis Pharmaceuticals |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002156 |
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.
Condition | Intervention | Phase |
---|---|---|
Cytomegalovirus Retinitis HIV Infections |
Drug: Fomivirsen sodium Drug: Ganciclovir |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Safety Study |
Official Title: | A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR ) |
Estimated Enrollment: | 194 |
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.
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:
United States, California | |
San Diego Naval Hosp | |
San Diego, California, United States, 92134 | |
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 | |
Univ of California San Francisco / SF Gen Hosp | |
San Francisco, California, United States, 94110 | |
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 and Throat Association | |
Charlotte, North Carolina, United States, 28204 | |
United States, Pennsylvania | |
Graduate Hosp | |
Philadelphia, Pennsylvania, United States, 191461192 | |
Hahnemann Univ Hosp | |
Philadelphia, Pennsylvania, United States, 19102 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
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 |
Study ID Numbers: | 251B, ISIS 2922-CS3 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002156 |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Ganciclovir Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
Antiviral Agents Cytomegalovirus Retinitis Injections |
Opportunistic Infections Sexually Transmitted Diseases, Viral Eye Diseases Eye Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis Retinitis Ganciclovir Cytomegalovirus Immunologic Deficiency Syndromes Fomivirsen |
Herpesviridae Infections Cytomegalovirus retinitis Virus Diseases HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Cytomegalovirus Infections DNA Virus Infections Cytomegalic inclusion disease Retroviridae Infections Retinal Diseases |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Eye Infections, Viral Immune System Diseases |
Therapeutic Uses Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |