HIV Infections
Conditions
Keywords
Acquired Immunodeficiency Syndrome, AIDS Vaccines, CD4 Lymphocyte Count, Salk HIV Immunogen
Brief summary
To provide product through an expanded access program to HIV-infected patients with CD4 counts less than 300 cells/ml.
Interventions
BIOLOGICALHIV-1 Immunogen
Sponsors
The Immune Response Corporation
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed