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Published on: September 5, 2016
Low-dose oral recombinant interferon-alpha A in patients with HIV-1 infection: a blinded pilot study
S J Sperber1, D J Gocke, C A Haberzettl
1Department of Medicine, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, New Jersey.
Objective:
To evaluate the efficacy of low-dose oral recombinant interferon-alpha (IFN-alpha A) on clinical parameters, body weight, CD4+ lymphocyte counts and natural killer cell cytolytic activity in HIV-infected patients.
Design:
Blinded crossover trial with controls for the protein and diluent components of the drug preparation.
Setting:
Medical school outpatient referral center.
Patients, Participants:
Eight patients with HIV-1 infection and a CD4+ lymphocyte count between 150 and 600 x 10(6)/l. Concurrent use of zidovudine was permitted.
Interventions:
Patients received (daily, by mouth) 10 ml of a study solution of 2.5% albumin for 6 weeks, 150 IU IFN-alpha A for 6 weeks, and normal saline for 6 weeks.
Main Outcome Measures:
After 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 cytolytic activity, were performed every 3 weeks. Complete physical examinations were conducted every 6 weeks.
Results:
No significant clinical or laboratory changes were observed during treatment with IFN-alpha A. Peak CD4+ lymphocyte counts were achieved at baseline in one patient, during albumin treatment in two patients, during IFN-alpha A treatment in one patient, and during saline treatment in four patients. All patients remained HIV-seropositive. Treatments were well-tolerated.
Conclusion:
This blinded pilot study of orally administered IFN-alpha A (150 IU daily for 6 weeks) did not demonstrate clinical benefit in HIV-infected patients.
