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To compare cidofovir with a commonly used treatment regimen, ganciclovir given by mouth (oral) and through an eye device (intraocular) , in order to determine the safety and effectiveness of cidofovir in preventing vision loss in patients who have AIDS complicated by CMV (cytomegalovirus) retinitis.
Cidofovir needs to be compared to ganciclovir to determine the best way to treat CMV retinitis.
While cidofovir is effective in suppressing retinitis and prolonging time to progression, no studies have compared cidofovir to other therapies and its place in the treatment of CMV retinitis remains unexplored. By combining the ganciclovir intraocular device (slows retinitis progression) with oral ganciclovir (has the potential to treat both the ocular disease and to suppress dissemination to the contralateral eye and the viscera), without the use of a central venous catheter, this combination has become increasingly common. For these reasons, a comparative trial of cidofovir to other therapies is appropriate.
After being stratified by the clinic and by stage of disease, patients are randomized to 1 of 2 treatment arms: intravenous (IV) cidofovir (Group I) or intraocular ganciclovir device plus oral ganciclovir (Group II). Group I: Cidofovir is administered IV once weekly for 2 consecutive weeks, then every 2 weeks thereafter. If progression occurs, oral ganciclovir is added to treatment or if this regimen is not tolerated, patients are treated according to the best medical judgment. Concurrent oral probenecid and intravenous hydration are administered with each cidofovir infusion. Group II: An intraocular ganciclovir device is surgically implanted at baseline and then every 6 to 8 months and ganciclovir is administered orally. If more than 1 progression or unacceptable toxicity occurs, patients are treated according to the best medical judgment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cidofovir | Drug | |||
| Probenecid | Drug | |||
| Ganciclovir | Drug |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Southern California / LA County USC Med Ctr | Los Angeles | California | 900331079 | United States | ||
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| UCLA CARE Ctr |
| Los Angeles |
| California |
| 90095 |
| United States |
| Univ of Miami / Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
| Emory Eye Clinic | Atlanta | Georgia | 30322 | United States |
| Northwestern Univ / SOCA | Chicago | Illinois | 60611 | United States |
| Charity Hosp / Tulane Univ Med School | New Orleans | Louisiana | 70112 | United States |
| Johns Hopkins Hosp | Baltimore | Maryland | 21287 | United States |
| Cornell Univ Med Ctr | New York | New York | 10021 | United States |
| New York Hosp / Cornell Med Ctr | New York | New York | 10021 | United States |
| Univ of North Carolina | Chapel Hill | North Carolina | 275997215 | United States |
| Julio Arroyo | West Columbia | South Carolina | 29169 | United States |
| Univ of Texas Galveston | Galveston | Texas | 775550435 | United States |
| ID | Term |
|---|---|
| D017726 | Cytomegalovirus Retinitis |
| D015658 | HIV Infections |
| D054069 | Multiple Acyl Coenzyme A Dehydrogenase Deficiency |
| ID | Term |
|---|---|
| D015828 | Eye Infections, Viral |
| D015817 | Eye Infections |
| D007239 | Infections |
| D003586 | Cytomegalovirus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005128 | Eye Diseases |
| D012173 | Retinitis |
| 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 |
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| ID | Term |
|---|---|
| D000077404 | Cidofovir |
| D011339 | Probenecid |
| D015774 | Ganciclovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003596 | Cytosine |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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