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
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: November 1993
History of Changes
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.
Drug : Ganciclovir
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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Topical or ophthalmic nucleoside analogs.
- Confirmation of HIV infection.
- Documented CMV infection.
- No past or present CMV disease (e.g., retinitis, colitis, esophagitis).
- Adequate visualization of the retina of both eyes by ophthalmologist.
- CD4 count <= 50 cells/mm3 (in patients WITHOUT a history of an AIDS-defining opportunistic infection or chronic gynecologic infection) OR CD4 count <= 100 cells/mm3 (in patients WITH a history of an AIDS-defining opportunistic infection or chronic gynecologic infection).
- Presence of gastrointestinal disease or symptoms not controlled with medications (e.g., persistent nausea, abdominal pain or persistent diarrhea within the past 4 weeks that is not controllable with medication).
- Inability to comply with protocol.
- The following nucleoside analogs:
- IV ganciclovir, IV acyclovir for more than 2 weeks total duration, oral acyclovir at doses > 1000 mg/day, vidarabine, amantadine hydrochloride, cytarabine, idoxuridine.
- FIAU, FIAC, foscarnet, CMV hyperimmune globulin, IV immune globulin, CMV monoclonal antibody, HPMPC.
- Imipenem-cilastatin (Primaxin).
Patients must have:
Patients with the following symptoms or conditions are excluded:
History of hypersensitivity to acyclovir.
Excluded within the past 60 days:
Ganciclovir, foscarnet, FIAC, FIAU, CMV hyperimmune globulin, CMV monoclonal antibody, or HPMPC.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002095
Locations Show More
|United States, California|
|East Bay AIDS Ctr|
|Berkeley, California, United States, 94705|
|Kraus - Beer Med Group|
|Los Angeles, California, United States, 90028|
|San Diego, California, United States, 92103|
|Davies Med Ctr / c/o HIV Institute|
|San Francisco, California, United States, 94114|
|Mount Zion Med Ctr|
|San Francisco, California, United States, 94115|
|San Francisco Veterans Administration Med Ctr|
|San Francisco, California, United States, 94121|
|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|
Sponsors and CollaboratorsHoffmann-La Roche
|Responsible Party:||Hoffmann-La Roche|
|ClinicalTrials.gov Identifier:||NCT00002095 History of Changes|
|Other Study ID Numbers:||059D|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Ganciclovir
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.