CD4 |
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Clinical Trial: An Expanded Access Open-Label, Compassionate Use Protocol of Remune in HIV-1-Infected Adults With CD4 Count Less Than 300 cells/ml
This study has been completed.
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Purpose
To provide product through an expanded access program to HIV-infected patients with CD4 counts less than 300 cells/ml.
| Condition | Treatment or Intervention |
|---|---|
| HIV Infections | Vaccine: HIV-1 Immunogen |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Open Label
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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.
Location Information
More Information
Record last reviewed: June 1995
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002172
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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