An Expanded Access Open-Label, Compassionate Use Protocol of Remune in HIV-1-Infected Adults With CD4 Count Less Than 300 Cells/Ml
Lead SponsorThe Immune Response Corporation
StatusCompleted No Results Posted
Intervention/Treatmenthiv-1 immunogen ...
To provide product through an expanded access program to HIV-infected patients with CD4 counts less than 300 cells/ml.
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.