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A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis Clinical research trials and A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis. A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis clinical trial. Test subjects typically obtain the finest healthcare available for their A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis  A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Isis Pharmaceuticals ,
Synopsis: 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
Details: This is a multicenter, prospective, randomized, open-label study comparing 2 dosage schedules of ISIS 2922.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment:
Location and Contact Information:
Vitreo - Retinal Consultants
New York City, New York, 10028
United States
Retina - Vitreous Associates Med Group
Los Angeles, California, 90017
United States
Dr Julio Perez
Ft. Lauderdale, Florida, 33060
United States
Univ of California San Francisco / SF Gen Hosp
San Francisco, California, 94110
United States
Indiana Univ Med Ctr
Indianapolis, Indiana, 46202
United States
Univ of Illinois
Chicago, Illinois, 60612
United States
Dr Alan Palestine
Washington D.C., District of Columbia, 20006
United States
New York Univ Med Ctr
New York City, New York, 10016
United States
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 191021192
United States
Charlotte Eye Ear Nose & Throat Association
Charlotte, North Carolina, 28204
United States
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610
United States
Duke Univ
Durham, North Carolina, 27710
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Georgia Retina
Atlanta, Georgia, 30327
United States
Community Eye Med Group
Pasadena, California, 911052536
United States
Novum Inc
Seattle, Washington, 98104
United States
Dr Jacob Lalezari
San Francisco, California, 94115
United States
Additional Information:
Study ID Numbers: 251D; ISIS 2922-CS9
Study Start Date:
Record last reviewed: December 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002187
Other Cytomegalovirus Retinitis Studies:
1. A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
2. A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment with Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People with AIDS
3. The Safety and Effectiveness of Ganciclovir Plus Interferon Beta in Preventing the Return of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
4. A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir
5. A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes
Related Studies:
Other Cytomegalovirus Retinitis Clinical Trials
Other California Clinical Trials
Other Pasadena Clinical Trials
A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
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