An Expanded Access Open Label Protocol of Remune (HIV-1 Immunogen) in HIV-1-Infected Adults With CD4 Count 550 Cells /Ml and Greater.
Completed · Not applicable
Conditions studied: HIV Infections
In brief
To provide an alternative therapy to HIV-infected patients for whom there is no comparable or satisfactory alternative drug or therapy available.
Key facts
- Study ID
- NCT00002173
- 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 >= 550 cells/ml.
- NOTE:
- If a patient's CD4 count is 550 to 600 cells/ml, the patient must either rescreen within 30 days 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.
- Current participation in a Remune study.
- Patients with any of the following prior conditions are excluded:
- Previous participation in a Remune study.
- Prior Medication:
- Excluded:
- Previous participation in a Remune study.
- Excluded within 30 days of study entry:
- Use of any immune-modulating drugs.
- 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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