Low-dose oral recombinant interferon-αA in patients with HIV-1 infection: a blinded pilot study

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ObjectiveTo evaluate the efficacy of low-dose oral recombinant interferon-α (IFN-αA) on clinical parameters, body weight, CD4+ lymphocyte counts and natural killer cell cytoiytic activity in HIV-infected patients.DesignBlinded crossover trial with controls for the protein and diluent components of the drug preparation.SettingMedical school outpatient referral center.Patients, participantsEight patients with HIV-1 infection and a CD4+ lymphocyte count between 150 and 600 χ 106/1. Concurrent use of zidovudine was permitted.InterventionsPatients received (daily, by mouth) 10 ml of a study solution of 2.5% albumin for 6 weeks, 150 IU IFN-αA for 6 weeks, and normal saline for 6 weeks.Main outcome measuresAfter two baseline visits, clinical assessments, vital signs, body weight, and laboratory tests, including enumeration of number and percentage of CD4+ and CD8+ lymphocytes and natural killer cell cytoiytic activity, were performed every 3 weeks. Complete physical examinations were conducted every 6 weeks.ResultsNo significant clinical or laboratory changes were observed during treatment with IFN-αA. Peak CD4+ lymphocyte counts were achieved at baseline in one patient, during albumin treatment in two patients, during IFN-αA treatment in one patient, and during saline treatment in four patients. All patients remained HIV-seropositive. Treatments were well-tolerated.ConclusionThis blinded pilot study of orally administered IFN-αA (150IU daily for 6 weeks) did not demonstrate clinical benefit in HIV-infected patients.

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