Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
13–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.