Document 0075
 DOCN  M9460075
 TI    A phase I study of interferon-alpha 2b in combination with interleukin-2
       in patients with human immunodeficiency virus infection.
 DT    9408
 AU    Schnittman SM; Vogel S; Baseler M; Lane HC; Davey RT Jr; Laboratory of
       Immunoregulation, National Institute of Allergy and; Infectious
       Diseases, National Institutes of Health, Bethesda,; Maryland.
 SO    J Infect Dis. 1994 May;169(5):981-9. Unique Identifier : AIDSLINE
       MED/94223103
 AB    Interferon-alpha (IFN-alpha) can inhibit human immunodeficiency virus
       (HIV-1) replication and is effective in treating Kaposi's sarcoma;
       interleukin-2 (IL-2) can increase circulating lymphocytes in
       HIV-1-infected patients. The safety of combination treatment with
       recombinant (r)IFN-alpha 2b and IL-2 was evaluated in HIV-1-infected
       patients with > 200 CD4+ T cells/mm3. A maximal tolerated dose of
       rIFN-alpha 2b was determined for 17 patients; then they received in
       combination 3, 6, or 12 x 10(6) IU/day rIL-2, given intravenously over
       21 days. Twelve patients ultimately received the combination, 9 for the
       full 21 days. Significant toxicities included flu-like symptoms, anemia,
       transaminemia, and depression. Transient increases in CD4+ T cell
       percentages and spontaneous lymphocyte blast transformation were
       observed. Quantitative microcultures demonstrate a decline in HIV titers
       in patients receiving rIFN-alpha 2b (5/9) with a further decline on
       addition of rIL-2 (7/9). In summary, continuous rIL-2 at 6 x 10(6)
       IU/day in combination with rIFN-alpha 2b was reasonably tolerated and
       provided preliminary evidence of immunomodulatory and antiviral
       activity.
 DE    Adolescence  Adult  Drug Therapy, Combination  Female  Human  HIV
       Infections/IMMUNOLOGY/PATHOLOGY/*THERAPY  *HIV-1
       Interferon-alpha/ADVERSE EFFECTS/*THERAPEUTIC USE  Interleukin-2/ADVERSE
       EFFECTS/*THERAPEUTIC USE  Leukocyte Count  Male  Middle Age  Recombinant
       Proteins/TOXICITY/THERAPEUTIC USE  Sarcoma, Kaposi's/PATHOLOGY/THERAPY
       T4 Lymphocytes  CLINICAL TRIAL  CLINICAL TRIAL, PHASE I  JOURNAL ARTICLE

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