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Virologic and immunologic activity of PegIntron in HIV disease.
- Source :
-
AIDS (London, England) [AIDS] 2009 Nov 27; Vol. 23 (18), pp. 2431-8. - Publication Year :
- 2009
-
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.<br />Design: This was a phase II, multicenter, randomized, double-blind, placebo-controlled study.<br />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.<br />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.<br />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.
- Subjects :
- Adult
Analysis of Variance
CD4 Lymphocyte Count
Double-Blind Method
Female
HIV Infections immunology
HIV Infections virology
Humans
Interferon alpha-2
Male
RNA, Viral blood
Recombinant Proteins
United States
Antiviral Agents therapeutic use
HIV Infections drug therapy
HIV-1 genetics
Interferon-alpha therapeutic use
Polyethylene Glycols therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1473-5571
- Volume :
- 23
- Issue :
- 18
- Database :
- MEDLINE
- Journal :
- AIDS (London, England)
- Publication Type :
- Academic Journal
- Accession number :
- 19898218
- Full Text :
- https://doi.org/10.1097/QAD.0b013e32832f30ca