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A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment with Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People with AIDS Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment with Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People with AIDS conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment with Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People with AIDS Clinical research trials and A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment with Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People with AIDS medical trials happen in hundreds of localities 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 typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment with Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People with AIDS. A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment with Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People with AIDS Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment with Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People with AIDS clinical trial. Participants frequently obtain the most expert healthcare available for their A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment with Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People with AIDS condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment with Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People with AIDS A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment with Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People with AIDS
A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment with Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People with AIDS
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: To compare the time to progression of CMV retinitis between oral ganciclovir and IV ganciclovir during 20 weeks of maintenance treatment. To compare the safety and tolerance of oral ganciclovir with IV ganciclovir therapy during 20 weeks of maintenance treatment. To describe the safety and tolerance of oral ganciclovir treatment when given concurrently with anti-retroviral treatment, e.g. zidovudine or ddI. To describe the survival of people with AIDS and CMV retinitis.
Details: Approximately 150 subjects with AIDS and newly diagnosed CMV retinitis will be enrolled in the study to achieve 120 randomized subjects. Eligible subjects will have CMV retinitis which has been diagnosed within one month of study entry by an ophthalmologist using indirect ophthalmoscopy. Subjects will be accrued by recruitment or referral. Anyone who volunteers for the study, meets the eligibility criteria, and signs an informed consent will be eligible for entry.
Eligibility:
Study Type: Interventional, Treatment, Placebo Control, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have the following: - Confirmation of HIV infection by HIV-antibody testing, p24 antigen assay, or culture of HIV, or have diagnosis of AIDS by CDC criteria. - CMV retinitis diagnosed within one month of study entry. - Understand the nature of the study, agree to its provisions, and sign the informed consent approved by the appropriate institutional review board and Syntex. Exclusion Criteria Concurrent Medication: The following are excluded: - Antimetabolites. Alkylating agents. Selected nucleoside analogs. Selected Cytokines. Patients with the following are excluded: - Persistent diarrhea, nausea, or abdominal pain or other clinically significant GI symptoms or uncontrolled gastrointestinal disease. Diarrhea is defined as 3 or more unformed stools per day. - Have ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment and photography. - Have ocular conditions requiring immediate surgical correction (e.g. retinal tear or detachment). - Require continuation of concomitant medications precluded by this protocol, e.g., antimetabolites, alkylating agents, selected nucleoside analogs, and selected cytokines and other medications listed in the protocol. - History of hypersensitivity to acyclovir or ganciclovir. - Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the subject to give informed consent or comply with the protocol. Prior Medication: The following are excluded: Previous use of anti-cytomegalovirus drug (e.g., ganciclovir, foscarnet, FIAC, or CMV hyperimmune globulin) within one month of study entry.
Total Enrollment: 150
Location and Contact Information:
Med Service
Miami, Florida, 33125
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Davies Med Ctr / c/o HIV Institute
San Francisco, California, 94114
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Saint Paul's Hosp
Vancouver, British Columbia,
Canada
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
United States
Cornell Univ Med College
New York City, New York, 10021
United States
East Bay AIDS Ctr
Berkeley, California, 94704
United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
United States
Dr David Busch
San Francisco, California, 94118
United States
New York Univ Med Ctr
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: 059B; ICM 1653
Study Start Date:
Record last reviewed: July 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002257
Other Hiv Infections Studies:
1. Effect of Interleukin-2 on HIV Treatment Interruption
2. A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
3. Hormone Replacement Therapy and Anti-HIV Drugs in HIV-Infected, Postmenopausal Women
4. A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir
5. Retrovirus Epidemiology Donor Study I (REDS I)
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A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment with Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People with AIDS
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