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| Sponsored by: |
Hoffmann-La Roche |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002095 |
Purpose
To evaluate the efficacy of oral ganciclovir in preventing progression to cytomegalovirus (CMV) disease (e.g., CMV retinitis, gastrointestinal CMV disease) in CMV-infected people with HIV infection and CD4 lymphocyte counts <= 100 cells/mm3. To evaluate the efficacy of this drug in reducing morbidity associated with coinfection by both CMV and HIV.
| Condition | Intervention |
|
Cytomegalovirus Infections HIV Infections |
Drug: Ganciclovir |
| MedlinePlus related topics: | AIDS Cytomegalovirus Infections |
| Drug Information available for: | Ganciclovir Ganciclovir sodium |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus |
Eligibility
| 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 or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior condition are excluded:
History of hypersensitivity to acyclovir.
Prior Medication:
Excluded within the past 60 days:
Ganciclovir, foscarnet, FIAC, FIAU, CMV hyperimmune globulin, CMV monoclonal antibody, or HPMPC.
Contacts and Locations| United States, California | |||||
| San Francisco Veterans Administration Med Ctr | |||||
| San Francisco, California, United States, 94121 | |||||
| Davies Med Ctr / c/o HIV Institute | |||||
| San Francisco, California, United States, 94114 | |||||
| East Bay AIDS Ctr | |||||
| Berkeley, California, United States, 94705 | |||||
| Mount Zion Med Ctr | |||||
| San Francisco, California, United States, 94115 | |||||
| UCSD | |||||
| San Diego, California, United States, 92103 | |||||
| Harbor - UCLA Med Ctr | |||||
| Torrance, California, United States, 90502 | |||||
| Kraus - Beer Med Group | |||||
| Los Angeles, California, United States, 90028 | |||||
| United States, District of Columbia | |||||
| Georgetown Univ Med Ctr | |||||
| Washington, District of Columbia, United States, 20007 | |||||
| United States, Florida | |||||
| Community Research Initiative | |||||
| Coral Gables, Florida, United States, 33146 | |||||
| United States, Georgia | |||||
| AIDS Research Consortium of Atlanta | |||||
| Atlanta, Georgia, United States, 30308 | |||||
| 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 | |||||
| Kaplan Cancer Ctr / New York Univ Med Ctr | |||||
| New York, New York, United States, 10016 | |||||
| St Lukes - Roosevelt Hosp Ctr | |||||
| New York, New York, United States, 10019 | |||||
| Cornell Univ Med College / New York Hosp | |||||
| New York, New York, United States, 10021 | |||||
| United States, Pennsylvania | |||||
| Univ of Pittsburgh / Graduate School of Public Health | |||||
| Pittsburgh, Pennsylvania, United States, 15261 | |||||
| Buckley Braffman Stern Med Associates | |||||
| Philadelphia, Pennsylvania, United States, 19107 | |||||
| United States, Texas | |||||
| Oak Lawn Physicians Group | |||||
| Dallas, Texas, United States, 75219 | |||||
| Infectious Diseases Association of Houston | |||||
| Houston, Texas, United States, 77030 | |||||
| Hoffmann-La Roche |
More Information
| Study ID Numbers: | 059D, ICM 1654 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002095 |
| Health Authority: | United States: Food and Drug Administration |
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