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
NCT ID: NCT00002095
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
700 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Ganciclovir
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Topical or ophthalmic nucleoside analogs.
Patients must have:
* 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).
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* 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.
Concurrent Medication:
Excluded:
* 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 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.
13 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Locations
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East Bay AIDS Ctr
Berkeley, California, United States
Kraus - Beer Med Group
Los Angeles, California, United States
UCSD
San Diego, California, United States
Davies Med Ctr / c/o HIV Institute
San Francisco, California, United States
Mount Zion Med Ctr
San Francisco, California, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States
Harbor - UCLA Med Ctr
Torrance, California, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Community Research Initiative
Coral Gables, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
Chicago, Illinois, United States
Beth Israel Hosp
Boston, Massachusetts, United States
Kaplan Cancer Ctr / New York Univ Med Ctr
New York, New York, United States
St Lukes - Roosevelt Hosp Ctr
New York, New York, United States
Cornell Univ Med College / New York Hosp
New York, New York, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States
Univ of Pittsburgh / Graduate School of Public Health
Pittsburgh, Pennsylvania, United States
Oak Lawn Physicians Group
Dallas, Texas, United States
Infectious Diseases Association of Houston
Houston, Texas, United States
Countries
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References
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Spector SA, McKinley GF, Lalezari JP, Samo T, Andruczk R, Follansbee S, Sparti PD, Havlir DV, Simpson G, Buhles W, Wong R, Stempien M. Oral ganciclovir for the prevention of cytomegalovirus disease in persons with AIDS. Roche Cooperative Oral Ganciclovir Study Group. N Engl J Med. 1996 Jun 6;334(23):1491-7. doi: 10.1056/NEJM199606063342302.
Other Identifiers
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ICM 1654
Identifier Type: -
Identifier Source: secondary_id
059D
Identifier Type: -
Identifier Source: org_study_id