Virologic and immunologic activity of PegIntron in HIV disease.

Abstract

OBJECTIVE:

The primary objectives of this study were to evaluate the safety, tolerability, and antiviral activity of pegylated interferon-alpha (PegIntron) in HIV-1 treatment-experienced patients failing their current antiretroviral regimen.

DESIGN:

This was a phase II, multicenter, randomized, double-blind, placebo-controlled study.

METHODS:

Patients were randomized to receive either weekly subcutaneous PegIntron 0.5, 1.0, 1.5, or 3 microg/kg or placebo added to their failing antiretroviral regimen for the first 4 weeks of study. Individuals who achieved more than 0.5 log10 reduction in HIV RNA at week 4 were allowed to continue study medication with optimization of their antiretroviral therapy for an additional 24 weeks.

RESULTS:

In the 259 patients included in the intent-to-treat analysis, changes in plasma HIV RNA from baseline to week 4 were -0.25 (P > 0.5), -0.46 (P = 0.024), -0.39 (P = 0.008), -0.53 (P < 0.001), and -0.17 (P > 0.5) log10 copies/ml in the 0.5, 1.0, 1.5, and 3.0 microg/kg and placebo arms, respectively. No significant changes were seen in CD4 T-cell parameters in any of the treatment or control arms. Adverse events (most commonly fever, flu-like symptoms, other constitutional symptoms, and psychiatric symptoms) resulted in discontinuation of study medication in 13, 17, 16, 28, and 2% of patients in the 0.5, 1.0, 1.5, 3.0 microg/kg, and placebo group, respectively.

CONCLUSION:

The demonstration of significant antiviral activity in a heavily pretreated patient population with acceptable toxicity and only weekly dosing makes PegIntron a potentially valuable therapy for patients with HIV infection that warrants further investigation in a broader population of patients.

• Authors: Jonathan B Angel, Wayne Greaves, Jianmin Long, Douglas Ward, Allan E Rodriguez, Daniele Scevola, Edwin DeJesus
• Journal: AIDS (London, England) (AIDS) Vol. 23 Issue 18 Pg. 2431-8 (Nov 27 2009) ISSN: 1473-5571 [Electronic] England
• PMID: 19898218 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antiviral Agents
• Interferon alpha-2
• Interferon-alpha
• RNA, Viral
• Recombinant Proteins
• Polyethylene Glycols
• peginterferon alfa-2b

Topics

• Adult
• Analysis of Variance
• Antiviral Agents (therapeutic use)
• CD4 Lymphocyte Count
• Double-Blind Method
• Female
• HIV Infections (drug therapy, immunology, virology)
• HIV-1 (genetics)
• Humans
• Interferon alpha-2
• Interferon-alpha (therapeutic use)
• Male
• Polyethylene Glycols (therapeutic use)
• RNA, Viral (blood)
• Recombinant Proteins
• United States