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AIDS Related Complex

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Lawrence Corey – One of the best experts on this subject based on the ideXlab platform.

Jan M Agosti – One of the best experts on this subject based on the ideXlab platform.

  • a randomized double blind phase i ii trial of tumor necrosis factor and interferon gamma for treatment of AIDS Related Complex protocol 025 from the AIDS clinical trials group
    AIDS Research and Human Retroviruses, 1992
    Co-Authors: Jan M Agosti, Robert W Coombs, Ann C Collier, Mary A Paradise, Jacqueline Benedetti, H S Jaffe, Lawrence Corey
    Abstract:

    To determine safety and efficacy of tumor necrosis factor (TNF) and interferon-gamma (IFNγ) in the treatment of patients with acquired immunodeficiency syndrome (AIDS)-Related Complex, a randomized, double-blind study was conducted. Twenty-five patients with AIDSRelated Complex and CD4 lymphocytes ≤500 x 106/L attended an AIDS Clinical Trials Unit of a tertiary referral center. Patients were administered tumor necrosis factor (TNF) (10 μg/m2) or IFNγ (10 μg/m2), or both intramuscularly three times weekly for 16 weeks. Side effects from all three preparations included fever, constitutional symptoms, and local reactions. No significant hematologic, hepatic, renal, or coagulation abnormalities were observed. CD4 lymphocyte counts, beta2-microglobulin, p24 antigen levels, and anti-p24 antibody did not change significantly during therapy. Similarly, no significant change was noted in rates of HIV isolation from peripheral blood mononuclear cells or plasma. TNF and IFNγ were tolerable after premedication with …

Lisa M. Dunkle – One of the best experts on this subject based on the ideXlab platform.

  • Stavudine In Patients With AIDS And AIDSRelated Complex: AIDS Clinical Trials Group 089
    Journal of Infectious Diseases, 1995
    Co-Authors: Henry W. Murray, Kathleen Squires, Walter Weiss, Sandi Sledz, Henry S. Sacks, Joseph Hassett, Anne H. Cross, Robert E. Anderson, Lisa M. Dunkle
    Abstract:

    In a phase I trial of stavudine in AIDS or AIDSRelated Complex (ARC), antiviral effects and safety were assessed in 41 patients treated with dosages of 0.5-12.0 mg/kg/day. Among evaluable patients, 10% increases in CD4 lymphocyte counts were sustained in 24 (60%) of 40 during treatment; an NAUC response (normalized area under the CD4 cell count-versus-time curve >1.0) was observed in 31 (91%) of 34 at 10 weeks and in 20 (80%) of 25 at 24 weeks; 15 (83%) of 18 had decreases in p24 antigenemia; and 24 (60%) of 40 gained ≥2.5 kg body weight. Median CD4 lymphocyte levels remained above baseline for 6 months in patients receiving >0.5 mg/kg/day. Median serum p24 antigen levels remained below baseline for ≥1 year in patients with p24 antigen responses. The principal toxicity was peripheral neuropathy, which generally resolved after drug discontinuation but limited the dosage to ≤2.0 mg/kg/day. Additional trials assessing the effect of stavudine on overall morbidity and mortality are ongoing

  • Pharmacokinetics of Stavudine in Patients with AIDS or AIDSRelated Complex
    The Journal of infectious diseases, 1992
    Co-Authors: Michael N. Dudley, Kathleen K. Graham, Sanjeev Kaul, Sandra M. Geletko, Lisa M. Dunkle, Marcia J. Browne, Kenneth H. Mayer
    Abstract:

    The pharmacokinetics of stavudine (d4T; 2′,3′-didehydro-3′-deoxythymidine) were studied in patients with AIDSRelated Complex or AIDS enrolled in a dose-ranging phase I/II study. Twenty-two patients were studied after the first oral dose of 0.67, 1.33, 2.67, or 4 mg/kg of body weight; 17 of them underwent an additional steady-state pharmacokinetic evaluation after thrice-daily dosing of the above doses. Stavudine absorption was rapid, with mean peak concentrations of 1.2-4.2 mg/L over the four dose levels studied. From 34% to 41% of an oral dose was excreted as unchanged drug in the urine. The mean values for plasma elimination half-life ranged from 1 to 1.6 h. The absolute bioavailability of a 4 mg/kg oral dose exceeded 80%. There was no change in pharmacokinetic parameters measured after the first dose and after chronic dosing. Stavudine is a new dideoxynucleoside with more complete and less variable oral absorption than existing nucleosides used for treatment of human immunodeficiency viruvirus infection.

H S Jaffe – One of the best experts on this subject based on the ideXlab platform.

  • a randomized double blind phase i ii trial of tumor necrosis factor and interferon gamma for treatment of AIDS Related Complex protocol 025 from the AIDS clinical trials group
    AIDS Research and Human Retroviruses, 1992
    Co-Authors: Jan M Agosti, Robert W Coombs, Ann C Collier, Mary A Paradise, Jacqueline Benedetti, H S Jaffe, Lawrence Corey
    Abstract:

    To determine safety and efficacy of tumor necrosis factor (TNF) and interferon-gamma (IFNγ) in the treatment of patients with acquired immunodeficiency syndrome (AIDS)-Related Complex, a randomized, double-blind study was conducted. Twenty-five patients with AIDSRelated Complex and CD4 lymphocytes ≤500 x 106/L attended an AIDS Clinical Trials Unit of a tertiary referral center. Patients were administered tumor necrosis factor (TNF) (10 μg/m2) or IFNγ (10 μg/m2), or both intramuscularly three times weekly for 16 weeks. Side effects from all three preparations included fever, constitutional symptoms, and local reactions. No significant hematologic, hepatic, renal, or coagulation abnormalities were observed. CD4 lymphocyte counts, beta2-microglobulin, p24 antigen levels, and anti-p24 antibody did not change significantly during therapy. Similarly, no significant change was noted in rates of HIV isolation from peripheral blood mononuclear cells or plasma. TNF and IFNγ were tolerable after premedication with …

Jacqueline Benedetti – One of the best experts on this subject based on the ideXlab platform.

  • a randomized double blind phase i ii trial of tumor necrosis factor and interferon gamma for treatment of AIDS Related Complex protocol 025 from the AIDS clinical trials group
    AIDS Research and Human Retroviruses, 1992
    Co-Authors: Jan M Agosti, Robert W Coombs, Ann C Collier, Mary A Paradise, Jacqueline Benedetti, H S Jaffe, Lawrence Corey
    Abstract:

    To determine safety and efficacy of tumor necrosis factor (TNF) and interferon-gamma (IFNγ) in the treatment of patients with acquired immunodeficiency syndrome (AIDS)-Related Complex, a randomized, double-blind study was conducted. Twenty-five patients with AIDSRelated Complex and CD4 lymphocytes ≤500 x 106/L attended an AIDS Clinical Trials Unit of a tertiary referral center. Patients were administered tumor necrosis factor (TNF) (10 μg/m2) or IFNγ (10 μg/m2), or both intramuscularly three times weekly for 16 weeks. Side effects from all three preparations included fever, constitutional symptoms, and local reactions. No significant hematologic, hepatic, renal, or coagulation abnormalities were observed. CD4 lymphocyte counts, beta2-microglobulin, p24 antigen levels, and anti-p24 antibody did not change significantly during therapy. Similarly, no significant change was noted in rates of HIV isolation from peripheral blood mononuclear cells or plasma. TNF and IFNγ were tolerable after premedication with …