Stable, chronically administered concomitant therapy for HIV infection and opportunistic diseases if patient has been on the regimen for at least one month prior to study entry.
Patients must have:
Required of Main group:
- Minimum CMV titer of 5000 PFU/ml in semen by quantitative CMV culture on one occasion within 30 days of entry.
- Demonstrating positive result of qualitative CMV culture in urine on one occasion within 30 days of entry.
Required of Satellite group:
- Must have CD4+ < 150 c/mm3 (or 10% of total lymphocytes) at screen.
Required of both groups:
- HIV infection.
- Life expectancy > 6 months.
- Able to comply with protocol requirements/instructions and likely to complete all study visits and evaluations as planned.
Stable, chronically administered concomitant therapy for HIV infection and opportunistic diseases for at least one month prior.
Patients with any of the following symptoms or conditions are excluded:
- Active CMV disease (retinitis, colitis, encephalitis, pneumonitis, etc.).
- Visual symptoms or signs suggestive of CMV disease (e.g., floaters, visual field defects, decreased visual acuity); Unless CMV disease is excluded via ophthalmoscopy examination.
- Active hepatitis, obstructive hepatobiliary diseases or cirrhosis.
- Gastrointestinal disorders which, in the judgement of the investigator, might interfere with oral dosing and drug absorption or may be indicative of CMV disease e.g., chronic nausea or vomiting, active bowel disease or persistent diarrhea.
- Diagnosis of chronic diseases such as diabetes or hypoglycemia, epilepsy, ongoing Grade II peripheral neuropathy, congestive heart failure, cardiomyopathy, other organ dysfunctions, etc., which in the opinion of the investigator, would compromise the safety or compliance of the patient.
- Participation in other investigational trials.
- Patients who are so debilitated as a result of their HIV disease or associated illness or therapies such that, in the investigator's opinion, the condition may interfere with the study assessments or the patient's ability to complete the entire study per protocol requirements.
Systemic therapy for visceral malignancy.
Treatment with radiation therapy for visceral malignancy.
Patients with any of the following prior symptoms or conditions are excluded:
- History of CMV disease (such as retinitis, colitis, encephalitis, pneumonitis, etc.)
- Known history of lactose intolerance.
- Systemic therapy for visceral malignancy within 2 months prior to entry.
- Prior treatment with ganciclovir, foscarnet, cidofovir, or other investigational anti-CMV drugs (e.g., intravenous acyclovir, lobucavir, valacyclovir) within 2 months prior to entry.
- Treated with interferons, immunomodulators or CMV hyperimmune globulin within 1 month prior to entry.
- Any investigational therapies within 1 month prior of study entry.
- Treatment with radiation therapy for visceral malignancy within 2 months prior to entry.
- Treatment with any investigational treatments within 1 month of study entry.