LOW-DOSE ORAL RECOMBINANT INTERFERON-ALPHA-A IN PATIENTS WITH HIV-1 INFECTION - A BLINDED PILOT-STUDY

Objective: To evaluate the efficacy of low-dose oral recombinant inter feron-alpha (IFN-alphaA) on clinical parameters, body weight, CD4+ lym phocyte counts and natural killer cell cytolytic activity in HIV-infec ted patients. Design: Blinded crossover trial with controls for the pr otein and diluent components of the drug preparation. Setting: Medical school outpatient referral center. Patients, participants: Eight pati ents with HIV-1 infection and a CD4+ lymphocyte count between 150 and 600 x 10(6)/l. Concurrent use of zidovudine was permitted. Interventio ns: Patients received (daily, by mouth) 10 ml of a study solution of 2 .5% albumin for 6 weeks, 150 IU IFN-alphaA for 6 weeks, and normal sal ine for 6 weeks. Main outcome measures: After two baseline visits, cli nical assessments, vital signs, body weight, and laboratory tests, inc luding enumeration of number and percentage of CD4+ and CD8+ lymphocyt es and natural killer cell cytolytic activity, were performed every 3 weeks. Complete physical examinations were conducted every 6 weeks. Re sults. No significant clinical or laboratory changes were observed dur ing treatment with IFN-alphaA. Peak CD4 + lymphocyte counts were achie ved at baseline in one patient, during albumin treatment in two patien ts, during IFN-alphaA treatment in one patient, and during saline trea tment in four patients. All patients remained HIV-seropositive. Treatm ents were well-tolerated. Conclusion: This blinded pilot study of oral ly administered IFN-alphaA (150 IU daily for 6 weeks) did not demonstr ate clinical benefit in HIV-infected patients.