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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: | NCT00002095 |
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 |
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Cytomegalovirus Infections HIV Infections |
Drug: Ganciclovir |
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 |
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.
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 |
Study ID Numbers: | 059D, ICM 1654 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002095 |
Health Authority: | United States: Food and Drug Administration |
Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome |
Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Ganciclovir Cytomegalovirus Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases |
HIV Infections Sexually Transmitted Diseases Cytomegalovirus Infections DNA Virus Infections Retroviridae Infections Cytomegalic inclusion disease |
Anti-Infective Agents Communicable Diseases RNA Virus Infections Slow Virus Diseases Immune System Diseases |
Therapeutic Uses Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |