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Sponsored by: |
Isis Pharmaceuticals |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002356 |
To evaluate the efficacy and safety of ISIS 2922 in AIDS patients with Cytomegalovirus ( CMV ) retinitis who are unresponsive or intolerant to ganciclovir and/or foscarnet but are otherwise ineligible for ISIS Pharmaceuticals' controlled trials OR who have failed ISIS 2922 therapy on another controlled clinical trial.
PER 2/8/96 AMENDMENT: Patients must rollover from another ISIS 2922 controlled trial.
Condition | Intervention | Phase |
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Cytomegalovirus Retinitis HIV Infections |
Drug: Fomivirsen sodium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Safety Study |
Official Title: | An Open-Label Study of the Safety and Efficacy of Intravitreal ISIS 2922 in Acquired Immune Deficiency Syndrome (AIDS) Patients With Cytomegalovirus Retinitis (NOTE: Restricted to Patients Who Rollover From Another Controlled ISIS 2922 Trial) |
Patients receive intravitreal injections of ISIS 2922 at doses of either 150 or 300 mcg, depending on CMV retinitis location and extent of retinal involvement. There is a 3-week Induction period followed by at least 18 weeks of Maintenance. Induction is given on days 1, 8, and 15, and Maintenance doses are given every 14 days, beginning on day 29.
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 are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Required:
Study ID Numbers: | 251C, ISIS 2922-CS7 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002356 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Acquired Immunodeficiency Syndrome Antiviral Agents Cytomegalovirus Retinitis |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Eye Diseases Eye Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis Retinitis Antiviral Agents Cytomegalovirus Immunologic Deficiency Syndromes |
Fomivirsen Herpesviridae Infections Virus Diseases HIV Infections Sexually Transmitted Diseases Cytomegalic Inclusion Disease Cytomegalovirus Infections DNA Virus Infections Retroviridae Infections Retinal 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 |