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| ID | Type | Description | Link |
|---|---|---|---|
| ICM 1774 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganciclovir | Drug |
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Bay AIDS Ctr | Berkeley | California | 94704 | United States | ||
| AIDS Clinical Research Ctr / UCLA Med Ctr |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9110064 | Background | Danner SA, Matheron S. Cytomegalovirus retinitis in AIDS patients: a comparative study of intravenous and oral ganciclovir as maintenance therapy. AIDS. 1996 Dec;10 Suppl 4:S7-11. |
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| Los Angeles |
| California |
| 900951793 |
| United States |
| UCSD Med Ctr / Pediatrics | San Diego | California | 92103 | United States |
| San Francisco Gen Hosp | San Francisco | California | 941102859 | United States |
| Davies Med Ctr / c/o HIV Institute | San Francisco | California | 94114 | United States |
| Mount Zion Med Ctr | San Francisco | California | 94115 | United States |
| Dr David Busch | San Francisco | California | 94118 | United States |
| Georgetown Univ Med Ctr | Washington D.C. | District of Columbia | 20007 | United States |
| Miami Veterans Administration Med Ctr | Miami | Florida | 33125 | United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | United States |
| Margo Heath - Chiozzi | Honolulu | Hawaii | 96816 | United States |
| Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll | Chicago | Illinois | 60612 | United States |
| Beth Israel Hosp | Boston | Massachusetts | 02215 | United States |
| Dr Dorothy Friedberg | New York | New York | 10016 | United States |
| Cornell Univ Med College | New York | New York | 10021 | United States |
| Buckley Braffman Stern Med Associates | Philadelphia | Pennsylvania | 19107 | United States |
| Oak Lawn Physicians Group | Dallas | Texas | 75219 | United States |
| Univ TX Galveston Med Branch | Galveston | Texas | 77550 | United States |
| Univ of Washington / Pacific Med Ctr | Seattle | Washington | 98144 | United States |
| Saint Paul's Hosp | Vancouver | British Columbia | Canada |
| ID | Term |
|---|---|
| D017726 | Cytomegalovirus Retinitis |
| D015658 | HIV Infections |
| D012173 | Retinitis |
| D054069 | Multiple Acyl Coenzyme A Dehydrogenase Deficiency |
| D003586 | Cytomegalovirus Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015828 | Eye Infections, Viral |
| D015817 | Eye Infections |
| D007239 | Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D028361 | Mitochondrial Diseases |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D015774 | Ganciclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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