Human Immunodeficiency Virus (HIV) and Cytomegalovirus (CMV) Viral Burden and Development of CMV End-Organ Disease: A Prospective Study in HIV-Infected Individuals.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

- Antivirals with anti-CMV activity (such as acyclovir, ganciclovir, valacyclovir,
valganciclovir, foscarnet, etc.) for reasons other than treatment of CMV disease.

- Antivirals for prophylaxis or treatment of other herpesvirus infections.

Patients must have:

- Documented HIV-1 infection.

- Documented evidence of CD4 count <= 50 cells/mm3 in the previous 24 months.

- Presence of serum CMV IgG antibodies.

- No history of CMV end-organ disease or evidence of active CMV disease prior to study
entry. NOTE: A history of positive CMV urine or blood cultures is acceptable as long
as it has been determined that the patient does not have CMV end-organ disease.

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

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

- Ocular media opacities that preclude adequate visualization of the fundi.

Patients with the following prior conditions are excluded:

- History of CMV end-organ disease.

- Any pre-existing necrotizing retinopathy that may interfere with a subsequent
diagnosis of CMV retinitis.