A Phase I/II Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease.

Inclusion Criteria

Concurrent Medication:

Allowed:

Patients with treated, stable toxoplasmosis encephalitis with documented stable CT or MR scans may be enrolled if maintenance suppressive therapy is continued.

Patients must have:

• Documented HIV infection.
• Encephalopathy or radiculomyelitis.
• CSF positive for CMV by PCR.
• Signed informed consent from a parent or legal guardian for patients < 18 years.
• CSF cytological analysis should be obtained at the time of enrollment or within 2 weeks prior to enrollment.

NOTE:

• Co-enrollment is encouraged where study procedures do not conflict. Protocols investigating antiviral regimens with potential activity against CMV or other human herpes viruses will be ineligible.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• Active CNS infection or malignancy, other than due to CMV or HIV.
• A positive CSF VDRL.
• Any evidence of active disease such as a substantial increase in cryptococcal antigen titer or positive culture. However, patients may be enrolled with stable, treated cryptococcal meningitis.
• A dermatomal or disseminated varicella-zoster infection within 30 days prior to enrollment.
• An active, symptomatic systemic infection, other tan HIV or CMV, for which the patient is not receiving stable therapy for at least 30 days.
• Any other advanced disease likely to cause death in <6 months.
• Known intolerance to both foscarnet and ganciclovir.
• Inability to safely perform a lumbar puncture.

Concurrent Medication:

Excluded:

• Patients on prophylactic antiviral therapy at the time of study enrollment will not be allowed to continue this medication during the study. In the event of the appearance of HSV or VZV infections after enrollment in the study that require systemic therapy, acyclovir or other appropriate medication may be instituted.
• Patients may not receive ZDV therapy during the initial 4 weeks of the study. Concurrent ZDV therapy will be started during maintenance therapy if tolerated. Bone marrow sparing antiretroviral therapy may be used at the investigator's discretion.

NOTE:

• Concurrent medications should be kept to a minimum because of possible interference with the assessment of both safety and pharmacokinetics. But medications absolutely necessary for the subject's welfare may be administered at the discretion of the investigator.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety