Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria

Patients must have:

HIV-1 seropositivity.
CD4 counts < 300 cells/ml.

NOTE:

If a patient's CD4 count is 275 to 300 cells/ml, the patient must either rescreen for Study 806 or wait 6 months before entering the expanded access program.
Patient must have failed or been intolerant to other comparable or alternative marketed therapies or must not be a candidate for such therapies.
Patient must not meet inclusion criteria for other Remune trials.
Patient must have laboratory tests within specified limits.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

Clinically significant cardiac, hepatic, renal, or gastrointestinal dysfunction.
Current participation in a Remune study.

Concurrent Medication:

Excluded:

Use of any immune-modulating drugs.
Induction therapy or initiation of new treatment regimen for an AIDS-defining condition.

Patients with any of the following prior conditions are excluded:

Previous participation in a Remune study.

Prior Medication:

Excluded:

Use of any immune-modulating drugs within 3 months of Day 1 visit.
Induction therapy or initiation of new treatment regimen for an AIDS-defining condition within 30 days of Day 1 visit.