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A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Clinical research trials and A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS. A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS clinical trial. Subjects frequently get the best healthcare possible for their A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Roche Global Development ,
Synopsis: To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.
Details: Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Topical and ophthalmic nucleoside analogues. Patients must have: - HIV positive. - No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis. - Currently stable retinitis. Prior Medication: Allowed: - Foscarnet prior to the 4 weeks of intravenous induction therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Persistent or clinically significant diarrhea, nausea, or abdominal pain. - Severe odynophagia. - Other gastrointestinal (GI) symptoms or uncontrolled GI disease. - Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis). - Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments. - Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance. Concurrent Medication: Excluded: - Acyclovir sodium (Zovirax) by any route other than topical. - Valacyclovir. - Brovavir. - Vidarabine. - Amantadine hydrochloride. - Cytarabine. - Idoxuridine. - Ribavirin. - Interferon. - Foscarnet (non-nucleoside pyrophosphate analogue). - CMV hyperimmune globulin. - Soluble CD4. - Trichosanthin (Compound Q). - Imipenem-cilastatin. - Isoprinosine. - Levamisole. - Other investigational drugs. Patients with the following prior condition are excluded: History of hypersensitivity to acyclovir or ganciclovir. Prior Medication: Excluded: - More than three induction regimens with intravenous anti-CMV therapy. - Any prior oral ganciclovir.
Total Enrollment: 280
Location and Contact Information:
AIDS Clinical Research Ctr / UCLA Med Ctr
Los Angeles, California, 900951793
United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215
United States
AIDS Clinical Trials Unit
St. Louis, Missouri, 63108
United States
Associates Med and Mental Health
Tulsa, Oklahoma, 74114
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Dr Dorothy Friedberg
New York City, New York, 10016
United States
Community Research Initiative
Coral Gables, Florida, 33146
United States
Univ of New Mexico
Albuquerque, New Mexico, 87131
United States
UCSD Med Ctr / Pediatrics
San Diego, California, 92103
United States
Texas Tech Health Sciences Ctr
El Paso, Texas, 79905
United States
East Bay AIDS Ctr
Berkeley, California, 94705
United States
AIDS Wellness Clinic
Sante Fe, New Mexico, 87501
United States
Margo Heath - Chiozzi
Honolulu, Hawaii, 96816
United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
United States
Univ of Maryland School of Medicine
Baltimore, Maryland, 21201
United States
New York Hosp - Cornell Med Ctr
New York City, New York, 10021
United States
McDowell Clinic
Phoenix, Arizona, 85006
United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
United States
Saint Paul's Hosp
Vancouver, British Columbia,
Canada
HIV Wellness Ctr / Univ Med Ctr
Las Vegas, Nevada, 89102
United States
Nalle Clinic
Charlotte, North Carolina, 282072198
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10019
United States
Univ of Alabama at Birmingham / AIDS Outpatient Clinic
Birmingham, Alabama, 35294
United States
Austin Infectious Disease Consultants
Austin, Texas, 78705
United States
Ohio State Univ Hosp
Columbus, Ohio, 432101228
United States
Mount Zion Med Ctr / UCSF
San Francisco, California, 94115
United States
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724
United States
Dr Ken Fisher
Phoenix, Arizona, 85013
United States
Infectious Diseases Association of Houston
Houston, Texas, 77030
United States
Dr Daniel Barbero
Ft. Worth, Texas, 76104
United States
Davies Med Ctr
San Francisco, California, 94114
United States
Additional Information:
Study ID Numbers: 059F; GANs2226
Study Start Date:
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002330
Other Cytomegalovirus Retinitis Studies:
1. A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS
2. Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
3. A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
4. The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients with HIV
5. A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
Related Studies:
Other Cytomegalovirus Retinitis Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
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