An Expanded Access Open-Label, Compassionate Use Protocol of Remune in HIV-1-Infected Adults With CD4 Count Less Than 300 Cells/Ml

Completed · Not applicable

Conditions studied: HIV Infections

In brief

To provide product through an expanded access program to HIV-infected patients with CD4 counts less than 300 cells/ml.

Key facts

Study ID: NCT00002172
Run by: The Immune Response Corporation
Last updated by the study team: 2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Immune Response Corp — Carlsbad, California, United States

Full record on ClinicalTrials.gov

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