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A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis Clinical research trials and A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis. A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis clinical trial. Test subjects typically receive the most expert healthcare available for their A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Roche Global Development ,
Synopsis: To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV) disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant. To compare safety and tolerance, time to progression, quality of life, and survival among patients treated with an intravitreal ganciclovir implant, with and without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.
Details: Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or IV ganciclovir.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Topical drugs and ophthalmics. Patients must have: - AIDS. - Unilateral CMV retinitis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Chronic, clinically significant diarrhea, nausea, abdominal pain,or other symptoms of uncontrolled gastrointestinal disease. - Ocular opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment of fundus photography. - Acute retinal necrosis or any other intraocular condition that might preclude study completion. - Ocular condition requiring immediate surgery. - Unable to have long-term IV catheter placement. Concurrent Medication: Excluded: - Vidarabine. - Amantadine hydrochloride. - Cytarabine. - FIAC or FIAU. - Idoxuridine. - Ribavirin. - Valacyclovir. - Foscarnet. - CMV hyperimmune globulin. - Soluble CD4. - Trichosanthin. - Imipenem-cilastatin. - Isoprinosine. - Levamisole. - Interferon. - Other investigational drugs. Patients with the following prior conditions are excluded: - History of previous invasive intraocular surgery of any kind in the involved eye or any condition for which ocular surgery is contraindicated. - History of hypersensitivity to acyclovir or ganciclovir. Prior Medication: Excluded: - Any prior oral ganciclovir in a CMV retinitis treatment protocol OR more than 4 months of prior oral ganciclovir in a prophylaxis study (per amendment). - Prior intravitreal ganciclovir implant. - More than two prior induction dose courses of IV anti-CMV therapy (per amendment). - Intravitreal injection of any antiviral medication within the past 4 weeks (per amendment).
Total Enrollment: 450
Location and Contact Information:
Univ of Washington Med Ctr
Seattle, Washington, 98195
United States
Dr Alan Palestine
Washington D.C., District of Columbia, 20036
United States
Vitreo - Retinal Consultants
New York City, New York, 10028
United States
Dr David Weinberg
Chicago, Illinois, 60611
United States
Dr Robert Avery
Santa Barbara, California, 93103
United States
Dr Dorothy Friedberg
New York City, New York, 10016
United States
UCI College of Medicine
Irvine, California, 92715
United States
Dr Neil Brourman
Beverly Hills, California, 90211
United States
New England Med Ctr / Tufts Univ
Boston, Massachusetts, 02111
United States
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Bascom Palmer
Miami, Florida, 33136
United States
Estelle Doheny Eye Clinic
Los Angeles, California, 90033
United States
Harbor - UCLA Med Ctr
Torrance, California, 90509
United States
Dr Michael Stewart
Jacksonville, Florida, 32204
United States
New York Hosp
New York City, New York, 10021
United States
Kaiser Hosp
San Francisco, California, 94115
United States
Saint Clare's Prof Office
New York City, New York, 10019
United States
Dr Robert T Wendel
Sacramento, California, 95819
United States
Emory Eye Clinic
Atlanta, Georgia, 30322
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Pacific Horizons Med Group
San Francisco, California, 94115
United States
Santa Clara Valley Med Ctr
San Jose, California, 95128
United States
Additional Information:
Study ID Numbers: 037B; GANS2304
Study Start Date:
Record last reviewed: July 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002134
Other Cytomegalovirus Retinitis Studies:
1. The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women
2. Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients
3. A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients with AIDS
4. A Prospective Double-Blind Study of Retrovir in Early HIV Infection
5. The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients with HIV Who Developed a Resistance to Protease Inhibitors
Related Studies:
Other Cytomegalovirus Retinitis Clinical Trials
Other California Clinical Trials
Other Sacramento Clinical Trials
A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
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