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A Study of the Safety and Tolerance of Long-Term Therapy with Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons with AIDS Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Study of the Safety and Tolerance of Long-Term Therapy with Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons with AIDS conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of the Safety and Tolerance of Long-Term Therapy with Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons with AIDS Clinical research trials and A Study of the Safety and Tolerance of Long-Term Therapy with Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons with AIDS medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Study of the Safety and Tolerance of Long-Term Therapy with Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons with AIDS. A Study of the Safety and Tolerance of Long-Term Therapy with Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons with AIDS Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Study of the Safety and Tolerance of Long-Term Therapy with Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons with AIDS clinical trial. Participants oftentimes recieve the finest healthcare available for their A Study of the Safety and Tolerance of Long-Term Therapy with Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons with AIDS condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), 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 Study of the Safety and Tolerance of Long-Term Therapy with Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons with AIDS  A Study of the Safety and Tolerance of Long-Term Therapy with Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons with AIDS
A Study of the Safety and Tolerance of Long-Term Therapy with Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons with AIDS
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: To evaluate the safety and tolerance of long-term ganciclovir (DHPG) therapy for newly diagnosed macular threatening Cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the clinical response to a 52 week course of intravenous DHPG therapy. To evaluate the safety and tolerance of long-term DHPG with concurrent treatment with zidovudine (AZT). (Patients utilizing treatment with other anti-retroviral drugs will be considered for study entry on a case by case basis.) To determine survival in this group of patients with AIDS and CMV retinitis.
Details:
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Topical acyclovir. - Selected cytokines. - Allowed after the first 4 weeks of ganciclovir: - Zidovudine (AZT) at a reduced dose (500 mg/day) in patients who have tolerated ganciclovir without grade 3/4 hematological toxicity. - Other anti-retrovirals after consultation with the Syntex study monitor. Patients must have the following: - AIDS and newly diagnosed Cytomegalovirus (CMV) retinitis. - An understanding of the nature of the study, agreement to its provisions, and willingness to sign the informed consent approved by the appropriate institutions review board, and Syntex. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk, or greater than 3000 microns from the fovea). - Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment. - Ocular conditions requiring immediate surgical correction (eg: - retinal tear or detachment). - Demonstrated hypersensitivity to acyclovir or ganciclovir. - Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to comply with the protocol. Concurrent Medication: Excluded: - Antimetabolites. - Alkylating agents. - Nucleoside analogs (excluding selected anti-retroviral agents). - Imipenem-cilastatin. - Interferons. - Selected cytokines. - Acyclovir (except topical acyclovir). Patients with the following are excluded: - Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk or greater than 3000 microns from the fovea). - Concomitant conditions or diseases described in Exclusion Co-Existing Conditions. Prior Medication: Excluded within 1 month of study entry: - Previous treatment with anti-cytomegalovirus therapy (e.g., ganciclovir, foscarnet or CMV hyperimmune globulin).
Total Enrollment: 100
Location and Contact Information:
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Dr Winkler Weinberg
Roswell, Georgia, 30076
United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Southern Alberta HIV Clinic / Foothills Hosp
Calgary, Alberta,
Canada
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
Dr Alfred F Burnside Jr
Columbia, South Carolina, 29204
United States
Additional Information:
Study ID Numbers: 029F; ICM 1692
Study Start Date:
Record last reviewed: January 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002034
Other Cytomegalovirus Retinitis Studies:
1. A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells
2. Treatment of Abnormal Adipose Tissue Accumulation in HIV Patients
3. A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons
4. Emotional Disclosure in HIV
5. Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients
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A Study of the Safety and Tolerance of Long-Term Therapy with Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons with AIDS
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