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
2 other identifiers
interventional
700
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 1993
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- 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).
You may not qualify if:
- Co-existing Condition:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Kraus - Beer Med Group
Los Angeles, California, 90028, United States
UCSD
San Diego, California, 92103, United States
Davies Med Ctr / c/o HIV Institute
San Francisco, California, 94114, United States
Mount Zion Med Ctr
San Francisco, California, 94115, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121, United States
Harbor - UCLA Med Ctr
Torrance, California, 90502, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Community Research Initiative
Coral Gables, Florida, 33146, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
Chicago, Illinois, 60612, United States
Beth Israel Hosp
Boston, Massachusetts, 02215, United States
Kaplan Cancer Ctr / New York Univ Med Ctr
New York, New York, 10016, United States
St Lukes - Roosevelt Hosp Ctr
New York, New York, 10019, United States
Cornell Univ Med College / New York Hosp
New York, New York, 10021, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Univ of Pittsburgh / Graduate School of Public Health
Pittsburgh, Pennsylvania, 15261, United States
Oak Lawn Physicians Group
Dallas, Texas, 75219, United States
Infectious Diseases Association of Houston
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 8618603BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1993-11