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Interferon-α in Patients with Asymptomatic Human Immunodeficiency Virus (HIV) Infection
A Randomized, Placebo-Controlled Trial
- H. Clifford Lane, MD;
- Victoria Davey, MPH;
- Joseph A. Kovacs, MD;
- Judith Feinberg, MD;
- Julia A. Metcalf, BA;
- Betsey Herpin, MSN;
- Robert Walker, MD;
- Lawrence Deyton, MD;
- Richard T. Davey, Jr., MD;
- Judith Falloon, MD;
- Michael A. Polis, MD, MPH;
- Norman P. Salzman, PhD;
- Michael Baseler, PhD;
- Henry Masur, MD; and
- Anthony S. Fauci, MD
Abstract
Study Objective: To evaluate the toxicity and clinical efficacy of interferon-α2b (IFN-α) in patients with asymptomatic human immunodeficiency virus (HIV) infection.
Design: Randomized, placebo-controlled, and double-blind study.
Setting: Outpatient clinic of a government referral-based research hospital.
Patients: Volunteer sample of 34 patients with asymptomatic HIV infection who had CD4 counts of 400 cells/mm3 or more, positive peripheral blood mononuclear cell cultures for HIV, or p24 antigenemia.
Interventions: Patients were randomly assigned to receive either IFN-α or placebo, 35 x 106 units per day subcutaneously. Doses of IFN-α or placebo were modified according to predefined laboratory and clinical criteria. Therapy lasted at least 12 weeks.
Measurements and Main Results: Seventeen patients were randomly assigned to each group. The two groups had similar mean CD4 counts at study entry. Thirty-five percent of patients assigned to receive IFN-α withdrew from the study because of toxicity. The average daily dose of IFN-α was 17.5 x 106 units. All patients receiving IFN-α reported flu-like symptoms; other toxicities included granulocytopenia (55%) and elevated liver enzyme levels (45%). While receiving IFN-α, 7 patients (41%) became HIV culture negative (three or more consecutive negative peripheral blood mononuclear cell cultures taken at least 2 weeks apart). In contrast, 2 patients in the placebo group (13%) became culture negative while on study (P = 0.05). During the treatment period, CD4 lymphocyte percentages were sustained at or above the baseline level in patients receiving IFN-α and declined slightly in patients receiving placebo. Of the 32 study patients followed after study (range, 5 to 33 months), no patients in the IFN-α group developed an acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection, compared with 5 patients in the placebo group (P = 0.02).
Conclusions: Treatment of early-stage HIV infection with IFN-α can result in a decrease in frequency of viral isolation. Although its use may be accompanied by dose-dependent toxicities, IFN-α may have a role in slowing progression of HIV disease.
Article and Author Information
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From the National Institutes of Health, Bethesda, Maryland; Georgetown University, Washington, D.C.; and Frederick Cancer Research Facility, Frederick, Maryland. For current author addresses, see end of text.
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Grant Support: In part by Federal funds from the Department of Health and Human Services under contract number NO1-CO-74102.
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Requests for Reprints: H. Clifford Lane, MD, Laboratory of Immunoregulation, NIAID, National Institutes of Health, Building 10, Room 11B13, 9000 Rockville Pike, Bethesda, MD 20892.
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Current Author Addresses: Drs. Lane and Davey and Ms. Davey, Metcalf, and Herpin: NIAID, National Institutes of Health, Building 10, Room 11B13, 9000 Rockville Pike, Bethesda, MD 20892.
Drs. Kovacs, Polis, Falloon, and Masur: Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 10D48, Bethesda, MD 20892.
Dr. Feinberg: Division of AIDS, Treatment Program, NIAID, National Institutes of Health, Room 203P, 6003 Executive Boulevard, Rockville, MD 20852.
Dr. Walker: Cardiovascular-Pulmonary Division, Hospital of the University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104.
Dr. Deyton: AIDS Program, National Institutes of Health, Control Data Building, Room 251P, 6003 Executive Boulevard, Rockville, MD 20852.
Dr. Baseler: National Cancer Institute-Frederick Cancer Research Facility, P.O. Box B, Building 469, Frederick, MD 21701.
Dr. Salzman: Georgetown University Medical Center, Department of Microbiology, Division of Molecular Virology and Immunology, Room LM12, Preclinical Science Building, 3900 Reservoir Road, NW, Washington, D.C. 20007.
Dr. Fauci: NIAID, National Institutes of Health, Building 31, Room 7A03, Bethesda, MD 20892.
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