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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002247 |
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.
Condition | Intervention |
---|---|
Cytomegalovirus Retinitis HIV Infections |
Drug: Ganciclovir |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Safety Study |
Official Title: | 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 |
Estimated Enrollment: | 225 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
United States, California | |
San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
Davies Med Ctr / c/o HIV Institute | |
San Francisco, California, United States, 94114 | |
UCSD Med Ctr / Pediatrics | |
San Diego, California, United States, 92103 | |
East Bay AIDS Ctr | |
Berkeley, California, United States, 94704 | |
Mount Zion Med Ctr | |
San Francisco, California, United States, 94115 | |
Dr David Busch | |
San Francisco, California, United States, 94118 | |
AIDS Clinical Research Ctr / UCLA Med Ctr | |
Los Angeles, California, United States, 900951793 | |
United States, District of Columbia | |
Georgetown Univ Med Ctr | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Miami Veterans Administration Med Ctr | |
Miami, Florida, United States, 33125 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 | |
United States, Hawaii | |
Margo Heath - Chiozzi | |
Honolulu, Hawaii, United States, 96816 | |
United States, Illinois | |
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll | |
Chicago, Illinois, United States, 60612 | |
United States, Massachusetts | |
Beth Israel Hosp | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Dr Dorothy Friedberg | |
New York, New York, United States, 10016 | |
Cornell Univ Med College | |
New York, New York, United States, 10021 | |
United States, Pennsylvania | |
Buckley Braffman Stern Med Associates | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Texas | |
Univ TX Galveston Med Branch | |
Galveston, Texas, United States, 77550 | |
Oak Lawn Physicians Group | |
Dallas, Texas, United States, 75219 | |
United States, Washington | |
Univ of Washington / Pacific Med Ctr | |
Seattle, Washington, United States, 98144 | |
Canada, British Columbia | |
Saint Paul's Hosp | |
Vancouver, British Columbia, Canada |
Study ID Numbers: | 059C, ICM 1774 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002247 |
Health Authority: | United States: Food and Drug Administration |
Retinitis Ganciclovir Cytomegalovirus Infections Administration, Oral Acquired Immunodeficiency Syndrome |
Sexually Transmitted Diseases, Viral Eye Diseases Eye Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis Retinitis Ganciclovir Cytomegalovirus Immunologic Deficiency Syndromes Herpesviridae Infections |
Cytomegalovirus retinitis Virus Diseases HIV Infections Sexually Transmitted Diseases Cytomegalovirus Infections DNA Virus Infections Cytomegalic inclusion disease Retroviridae Infections Retinal Diseases |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Eye Infections, Viral Immune System Diseases |
Therapeutic Uses Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |