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
Cytomegalovirus Infections, HIV Infections
About this trial
This is an interventional treatment trial for Cytomegalovirus Infections focused on measuring Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
Eligibility Criteria
Inclusion Criteria 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). Exclusion Criteria 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.
Sites / Locations
- East Bay AIDS Ctr
- Kraus - Beer Med Group
- UCSD
- Davies Med Ctr / c/o HIV Institute
- Mount Zion Med Ctr
- San Francisco Veterans Administration Med Ctr
- Harbor - UCLA Med Ctr
- Georgetown Univ Med Ctr
- Community Research Initiative
- AIDS Research Consortium of Atlanta
- Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
- Beth Israel Hosp
- Kaplan Cancer Ctr / New York Univ Med Ctr
- St Lukes - Roosevelt Hosp Ctr
- Cornell Univ Med College / New York Hosp
- Buckley Braffman Stern Med Associates
- Univ of Pittsburgh / Graduate School of Public Health
- Oak Lawn Physicians Group
- Infectious Diseases Association of Houston