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 interferon-alpha (IFN-alpha A) on clinical parameters, body weight, CD4+ lymphocyte counts and natural killer cell cytolytic activity in HIV-infected patients.


METHODS
Blinded crossover trial with controls for the protein and diluent components of the drug preparation.


METHODS
Medical school outpatient referral center.


METHODS
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.


METHODS
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.


METHODS
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.


CONCLUSIONS
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.
Sperber
S J
SJ
Department of Medicine, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, New Jersey.
Gocke
D J
DJ
Haberzettl
C A
CA
Pestka
S
S
D000284:Administration, Oral; D000328:Adult; D015496:CD4-Positive T-Lymphocytes; D003602:Cytotoxicity, Immunologic; D004361:Drug Tolerance; D005260:Female; D015658:HIV Infections / Q000276:immunology / Q000628:therapy*; D015497:HIV-1; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D007694:Killer Cells, Natural / Q000276:immunology; D007958:Leukocyte Count; D008297:Male; D011994:Recombinant Proteins
D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins