An Expanded Access Open-Label, Compassionate Use Protocol of Remune in HIV-1-Infected Adults With CD4 Count Less Than 300 Cells/Ml
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have:
CD4 counts < 300 cells/ml.
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.
Patients with the following symptoms and conditions are excluded:
Clinically significant cardiac, hepatic, renal, or gastrointestinal dysfunction.
Current participation in a Remune study.
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.
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.