Expired Study
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Bethesda, Maryland 20892


Purpose:

To compare the effects of low-dose versus high-dose subcutaneous ( SC ) aldesleukin ( interleukin-2; IL-2 ) on immunologic and virologic markers in HIV-infected patients. To compare the effects of monthly versus bimonthly administration of SC IL-2 on these markers. Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit.


Study summary:

Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit. Patients are randomized to one of four treatment arms; patients receive either low-dose or high-dose SC IL-2 for 5 days either on a monthly or bimonthly schedule for approximately 6 months.


Criteria:

Inclusion Criteria Patients must have: - HIV positivity. - CD4 count >= 500 cells/mm3. - No history of AIDS-defining opportunistic infection, or malignancy other than mucocutaneous Kaposi's sarcoma. Concurrent Medication: Required: - Concurrent FDA-approved antiretroviral therapy (AZT, ddI, ddC, d4T). Prior Medication: Required: - FDA-approved antiretroviral therapy for at least 6 weeks prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Significant cardiac, pulmonary, thyroid, renal, or CNS disease. Prior Medication: Excluded: - Prior IL-2. - Systemic corticosteroids, chemotherapy, or experimental therapy within 4 weeks prior to study entry.


NCT ID:

NCT00000821


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 22, 2017

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