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| Sponsor: | 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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment |
| 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 | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| Kraus - Beer Med Group | |
| Los Angeles, California, United States, 90028 | |
| UCSD | |
| San Diego, California, United States, 92103 | |
| Mount Zion Med Ctr | |
| San Francisco, California, United States, 94115 | |
| 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 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| 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 | |
| Buckley Braffman Stern Med Associates | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Univ of Pittsburgh / Graduate School of Public Health | |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| United States, Texas | |
| Oak Lawn Physicians Group | |
| Dallas, Texas, United States, 75219 | |
| Infectious Diseases Association of Houston | |
| Houston, Texas, United States, 77030 | |
More Information
| Study ID Numbers: | 059D, ICM 1654 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002095 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome |
|
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Ganciclovir Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes |
Herpesviridae Infections Virus Diseases HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Cytomegalovirus Infections DNA Virus Infections Retroviridae Infections |