The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients

Inclusion Criteria

Concurrent Medication:

Allowed:

• Chronically administered concomitant therapies for HIV and opportunistic diseases, including chemotherapy for cutaneous Kaposi's sarcoma, must be on these therapies for at least 30 days prior to study entry.

• Short courses of oral antibiotics or other therapies given for a limited period of 3 weeks.

• Episodic use of IV acyclovir or oral acyclovir > 1g/day for treatment of acute illness is permitted at the clinician's discretion.

Patients must have:

• A working diagnosis of HIV infection based on the patient's medical history, behavioral history, clinical signs and symptoms, or results of other laboratory tests.

• CD4+ cell count <= 100 cells/mm3 within 60 days prior to randomization (OR, AS PER AMENDMENT 8/7/97, a CD4+ cell count that is both > 100 and <= 200 cells/mm3 within 60 days prior to randomization and a documented nadir CD4+ cell count <= 50 cells/ mm3 at any time prior to randomization).

• Reasonably good health.

• Life expectancy of at least 6 months.

• Access to a refrigerator for the storage of adefovir dipivoxil.

• Signed informed consent from parent or legal guardian for patients less than 18 years of age.

AS PER AMENDMENT 8/7/97:

• CMV serology (IgG) positive (CMV bDNA cohort and CMV-virology cohort).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• Evidence of active CMV disease at screening.

• Conditions that would require use of medications listed in Exclusion Concurrent Medications.

Concurrent Medication:

Excluded:

• Any investigational anti-CMV agent.

• Adenine arabinoside (vidarabine).

• Amantadine hydrochloride (Symmetrel).

• Cidofovir (Vistide).

• CMV hyperimmune globulin.

• Cytosine arabinoside (cytarabine).

• Famciclovir.

• Foscarnet (phosphonoformic acid).

• Ganciclovir (Cytovene).

• GW 1263W94 (Benzamidazole).

• Idoxuridine.

• Intravenous acyclovir.

• ISIS 2922 (Anti-sense).

• Lobucavir.

• MSL109.

• Oral acyclovir > 1 g/day.

• Valacyclovir.

Patients with the following prior conditions are excluded:

• History of CMV end-organ disease.

Prior Medication:

Excluded within 2 weeks of randomization:

• Any investigational anti-CMV agent.

• Adenine arabinoside (vidarabine).

• Amantadine hydrochloride (Symmetrel).

• Cidofovir (Vistide).

• CMV hyperimmune globulin.

• Cytosine arabinoside (cytarabine).

• Famciclovir.

• Ganciclovir (Cytovene).

• GW 1263W94 (Benzamidazole).

• Idoxuridine.

• Intravenous acyclovir.

• ISIS 2922 (Anti-sense).

• Lobucavir.

• MSL109.

• Oral acyclovir > 1 g/day.

• Valacyclovir.

Excluded within 60 days prior to study entry:

• Foscarnet.