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A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients 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 Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS Clinical research trials and A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients 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 Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS. A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients 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 Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS clinical trial. Participants oftentimes recieve the finest healthcare available for their A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients 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 Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS  A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Hoffmann-La Roche
Synopsis: To provide information about the usefulness and safety of giving injections of ganciclovir (DHPG) for treating peripheral cytomegalovirus (CMV) retinitis. CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG.
Details: CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG. Patients are randomly placed in one of two treatment groups. In one group, patients receive DHPG twice a day, intravenously, for 14 days, followed by a daily dose for 14 weeks. Patients in the other group (the delayed-treatment group) do not receive immediate treatment with DHPG. Patients in both groups have regular ophthalmologic (eye) evaluations with retinal photographs to see if the retinitis is getting worse. Patients in the delayed treatment group receive DHPG if this occurs.
Eligibility:
Study Type: Interventional, Treatment, Placebo Control
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Zidovudine (AZT) for patients in delayed treatment group and not receiving ganciclovir. - Didanosine (ddI) may be continued or initiated in any patient during the study. - Topical acyclovir. - Topical ophthalmics. - Aerosolized pentamidine. Patients must have: - AIDS as defined by the CDC criteria or have had confirmation of HIV infection by ELISA, p24 antigen assay, or culture of HIV. - Retinal lesions greater than 1500 microns from edge of optic disc outside major temporal vascular arcades, and greater than 3000 microns from fovea. - Understanding of study provisions, and willingness to sign informed consent form approved by the appropriate Institutional Review Board and Syntex. - Life expectancy of at least 4 months. Exclusion Criteria Co-existing Condition: Patients with ocular conditions requiring immediate surgical correction are excluded. Concurrent Medication: Excluded during first 4 weeks of ganciclovir treatment: Zidovudine (AZT). Excluded: Other investigational drugs and antimetabolites, alkylating agents, nucleoside analogs (topical ophthalmics are permitted), acyclovir, interferon, foscarnet (non-nucleoside pyrophosphate analog), cytomegalovirus (CMV) hyperimmune globulin, and cytokines. Patients with the following are excluded: - Immediately sight-threatening retinitis (= or < 1500 microns from edge of optic disc, or inside major temporal vascular arcades, or = or < 3000 microns from the fovea). - Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic and photographic retinal assessment. - Demonstrated hypersensitivity to acyclovir. Prior Medication: Excluded: Previous treatment with anti-cytomegalovirus therapy.
Total Enrollment: 180
Location and Contact Information:
Overall Study Official:
SpectorSA, Study Chair,
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Washington Univ Med Ctr
St. Louis, Missouri, 63110
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
New York Univ Med Ctr / Dept of Environmental Med
New York City, New York, 10016
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Plaza Med Ctr
Houston, Texas, 77004
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Mount Zion Med Ctr
San Francisco, California, 94115
United States
Mills Hosp
San Mateo, California, 94401
United States
Pacific Presbyterian
San Francisco, California, 94118
United States
Kansas City Veterans Administration Med Ctr
Kansas City, Missouri, 64128
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Infectious Diseases Association of Houston / Methodist Hosp
Houston, Texas, 77030
United States
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, 87131
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Additional Information:
Study ID Numbers: ACTG 071; RS-21592,ICM 1697
Study Start Date:
Record last reviewed: October 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000688
Other Cytomegalovirus Retinitis Studies:
1. A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
2. Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
3. An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
4. A Study of Cidofovir in HIV-Infected Children with Cytomegalovirus (CMV) Disease
5. The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
Related Studies:
Other Cytomegalovirus Retinitis Clinical Trials
Other New Mexico Clinical Trials
Other Albuquerque Clinical Trials
A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
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