Cytomegalovirus Retinitis, HIV Infections
Conditions
Keywords
AIDS-Related Opportunistic Infections, Antiviral Agents, Drug Administration Schedule, Cytomegalovirus Retinitis, fomivirsen, Vitreous Body
Brief summary
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
Detailed description
This is a multicenter, prospective, randomized, open-label study comparing 2 dosage schedules of ISIS 2922.
Interventions
Sponsors
Ionis Pharmaceuticals, Inc.
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Allowed: * Oral ganciclovir. * Leukocyte growth factors (GM-CSF and G-CSF) for patients with febrile neutropenia. Patients must have: * Documented AIDS. * Clinical diagnosis of advanced CMV retinitis in 1 or both eyes. * \>= 2 previous induction courses with anti-CMV retinitis therapy licensed by a regulatory agency. * \> 25% retinal involvement with CMV retinitis. * Baseline CMV retinitis lesions which have leading edges \> 1000 micrograms from the macula or optic disk. Prior Medication: Required: * \>= 2 previous induction courses with anti-CMV retinitis therapy licensed by a regulatory agency. Allowed: * All anti-CMV therapies other than ganciclovir must be discontinued no less than 2 days prior to entry.
Exclusion criteria
Co-existing Condition: Patients with the following symptoms and conditions are excluded: * External ocular infection in the eye to be treated. * Other herpetic infections of the retina, toxoplasma, retinochoroiditis, or other disease of the fundus that would preclude assessment of CMV retinitis in the eye to be treated. * Ocular conditions that will obstruct visualization of the posterior ocular structures on the eye to be treated. * Retinal detachment in the eye to be treated. * Ganciclovir implant in the eye to be treated. * Known or suspected allergy to phosphorothioate oligonucleotides or intolerance of ISIS 2922. * Silicone oil in the eye to be treated. * Pseudoretinitis pigmentosa. * Syphilis. Patients with the following prior conditions are excluded: * History of surgery to correct retinal detachment in the eye to be treated. * History of syphilis. 1\. Systemic anti-CMV therapies other than oral ganciclovir. * Mellaril, Stelazine, chlorpromazine and clofazimine. * Combination use of ethambutol and fluconazole. * Investigational medications and/or procedures for the treatment of CMV retinitis in the eye to be treated. * Ganciclovir implant delivery device in the eye to be treated. * Ganciclovir other than oral. * Foscarnet.
Countries
United States
Outcome results
None listed