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.