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A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR ) Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR ) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR ) Clinical research trials and A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR ) healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR ). A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR ) Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR ) clinical trial. Subjects frequently obtain the most expert healthcare possible for their A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR ) condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )  A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Isis Pharmaceuticals ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - AIDS. - CMV retinitis that is not adequately controlled (previously diagnosed patients with smoldering CMV retinitis or those with active CMV retinitis borders on indirect ophthalmoscopy). - No more than one previous progression of CMV retinitis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions in the eye to be treated are excluded: - External ocular infection. - Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus. - Ocular condition that will obstruct visualization of the posterior ocular structures. - Retinal detachment. - Silicone oil in eye. Patients with the following other symptoms or conditions are excluded: - Known or suspected allergy to phosphorothioate oligonucleotides. - Syphilis. - Retinal pigment epithelial stippling not associated with CMV retinitis. - Pseudoretinitis pigmentosa. - Chronic diarrhea that would impair absorption of oral ganciclovir. - Intolerance to ganciclovir. Concurrent Medication: Excluded: - Foscarnet or other anti-CMV agents other than ganciclovir. - Mellaril. - Stelazine. - Thorazine. - Clofazimine. - Ethambutol/fluconazole combination. - Investigational medications for CMV retinitis. Concurrent Treatment: Excluded: - Investigational procedures for CMV retinitis. Patients with the following prior conditions are excluded: - History of surgery to correct retinal detachment in eye to be treated. - History of intolerance to ISIS 2922. Prior Medication: Excluded: - Prior ganciclovir implant for CMV retinitis. - More than 4 months of prior ganciclovir.
Total Enrollment: 194
Location and Contact Information:
Univ of Illinois
Chicago, Illinois, 60612
United States
Novum Inc
Seattle, Washington, 98104
United States
Indiana Univ Med Ctr
Indianapolis, Indiana, 46202
United States
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 19102
United States
Univ of California San Francisco / SF Gen Hosp
San Francisco, California, 94110
United States
Virginia Eye Consultants
Norfolk, Virginia, 23507
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Community Eye Med Group
Pasadena, California, 911052536
United States
Georgia Retina
Atlanta, Georgia, 30327
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Charlotte Eye Ear Nose and Throat Association
Charlotte, North Carolina, 28204
United States
Dr Julio Perez
Ft. Lauderdale, Florida, 33060
United States
Vitreo - Retinal Consultants
New York City, New York, 10028
United States
Retina - Vitreous Associates Med Group
Los Angeles, California, 90017
United States
San Diego Naval Hosp
San Diego, California, 92134
United States
Graduate Hosp
Philadelphia, Pennsylvania, 191461192
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 752359057
United States
Santa Clara Valley Med Ctr
San Jose, California, 95128
United States
Additional Information:
Study ID Numbers: 251B; ISIS 2922-CS3
Study Start Date:
Record last reviewed: December 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002156
Other Hiv Infections Studies:
1. An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
2. A Study of Indinavir Taken with or without DMP 266
3. A Study to Compare the Effectiveness of a Four Drug Anti-HIV Regimen Given Alone or in Combination with GM-CSF or IL-12 to HIV-Positive Patients
4. A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
5. A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible
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A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
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