Format

Send to

Choose Destination
AIDS. 1993 May;7(5):693-7.

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

Author information

1
Department of Medicine, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, New Jersey.

Abstract

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.

PMID:
8100421
[Indexed for MEDLINE]

Supplemental Content

Loading ...
Support Center