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

T

The Immune Response Corporation

Status

Completed

Conditions

HIV Infections

Treatments

Biological: HIV-1 Immunogen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002172
093
901

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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