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A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People with AIDS Who Have Received Prior Ganciclovir Therapy 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 Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People with AIDS Who Have Received Prior Ganciclovir Therapy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People with AIDS Who Have Received Prior Ganciclovir Therapy Clinical research trials and A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People with AIDS Who Have Received Prior Ganciclovir Therapy 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 Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People with AIDS Who Have Received Prior Ganciclovir Therapy. A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People with AIDS Who Have Received Prior Ganciclovir Therapy 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 Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People with AIDS Who Have Received Prior Ganciclovir Therapy clinical trial. Participants oftentimes recieve the finest healthcare available for their A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People with AIDS Who Have Received Prior Ganciclovir Therapy 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 Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People with AIDS Who Have Received Prior Ganciclovir Therapy A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People with AIDS Who Have Received Prior Ganciclovir Therapy
A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People with AIDS Who Have Received Prior Ganciclovir Therapy
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: To compare the safety and tolerance of oral ganciclovir at a double dose 3 times/day or a single dose 6 times/day to IV ganciclovir given for 20 weeks of maintenance therapy. To compare the time to progression of cytomegalovirus (CMV) retinitis between two regimens of oral ganciclovir and IV ganciclovir therapy given for 20 weeks of maintenance therapy. To describe the efficacy and safety of double dose versus single dose oral ganciclovir in patients who have a progression of retinitis while on the originally assigned maintenance treatment. To describe the safety, tolerance, and time to progression of retinitis during the 52 weeks of oral ganciclovir maintenance therapy in people with AIDS. To describe the safety and tolerance of oral ganciclovir maintenance therapy when given concurrently with antiretroviral treatment (e.g., zidovudine, ddI, or ddC). To describe survival of people with AIDS and CMV retinitis.
Details: Two hundred twenty-five patients with AIDS and CMV retinitis are eligible for enrollment in Groups A, B, and C of the study, provided that each subject has received and tolerated a therapeutic course of intravenous (IV) ganciclovir of at least 4 weeks duration resulting in stable retinitis. An additional 100 subjects who have received and tolerated a course of IV or oral ganciclovir under any clinical trial of oral ganciclovir sponsored by Syntex Research and have stable retinitis may enter into Group D of this study and receive oral ganciclovir.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Zidovudine except during the first 2 weeks of any oral or IV ganciclovir maintenance therapy. - ddI. - ddC. Patients must have: - Confirmed HIV infection or diagnosis of AIDS. - CMV retinitis of no more than 4 months duration. - Stable retinitis. - Understanding of the nature of the study, agree to its provisions, and sign informed consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Persistent or clinically significant diarrhea (3 or more unformed stools/day), nausea, or abdominal pain or other gastrointestinal symptoms or uncontrolled gastrointestinal disease. - Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment. - Ocular conditions requiring immediate surgical correction (e.g., retinal tear or detachment). - Dementia, decreased mentation, or other encephalopathic signs and symptoms that would interfere with the ability of the subject to give informed consent or comply with the protocol. Concurrent Medication: Excluded: - Zidovudine during the first 2 weeks of any oral or IV ganciclovir maintenance therapy. - Antimetabolites. - Alkylating agents. - Selected nucleoside analogs. - Selected cytokines. Patients with the following prior conditions are excluded: - Diagnosis of CMV retinitis more than 4 months prior to study entry. - More than two prior induction treatments of IV ganciclovir (initial induction and one re-induction are permitted). Prior Medication: Excluded: - More than two induction treatment regimens with IV ganciclovir. - Prior oral ganciclovir (in Groups A, B, and C only).
Total Enrollment: 225
Location and Contact Information:
AIDS Clinical Research Ctr / UCLA Med Ctr
Los Angeles, California, 900951793
United States
Margo Heath - Chiozzi
Honolulu, Hawaii, 96816
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
United States
UCSD Med Ctr / Pediatrics
San Diego, California, 92103
United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
United States
Cornell Univ Med College
New York City, New York, 10021
United States
Univ of Washington / Pacific Med Ctr
Seattle, Washington, 98144
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Dr Dorothy Friedberg
New York City, New York, 10016
United States
Dr David Busch
San Francisco, California, 94118
United States
Davies Med Ctr / c/o HIV Institute
San Francisco, California, 94114
United States
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
Chicago, Illinois, 60612
United States
East Bay AIDS Ctr
Berkeley, California, 94704
United States
Saint Paul's Hosp
Vancouver, British Columbia,
Canada
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Mount Zion Med Ctr
San Francisco, California, 94115
United States
Beth Israel Hosp
Boston, Massachusetts, 02215
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
Oak Lawn Physicians Group
Dallas, Texas, 75219
United States
Additional Information:
Study ID Numbers: 059C; ICM 1774
Study Start Date:
Record last reviewed: March 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002247
Other Hiv Infections Studies:
1. Effects of Immunization with HIV-1 Immunogen Plus Anti-HIV Treatment Interruption on the Levels of HIV
2. A Study to Demonstrate that Anti-HIV Drug Therapy can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination from the Body
3. The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined with Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
4. Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Suspected Latent Tuberculous Infection
5. A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
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A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People with AIDS Who Have Received Prior Ganciclovir Therapy
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