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Abstract
ANTIVIRAL ACTIVITY AND TOLERABILITY OF PEG-INTRON IN HIV PATIENTS FAILING HAART
NIETO L, ANGEL J, GAZZARD B, CAHN P, WARD D, RAMIREZ-RONDA C, TAGLIETTI M, GREAVES W
Background: PEG-Intron is a pegylated formulation of Intron A (interferon alfa-2B) which in phase I studies demonstrated a decrease in HIV RNA in HIV-infected patients. The objectives of this trial were to: investigate the antiviral activity, safety, and tolerability of PEG-Intron in treatment-experienced patients failing their current HAART regimen.
Methods: 261 patients in this phase II multicenter, randomized, double blind, placebo-control study were assigned to one of 5 treatment arms: 0.5, 1.0, 1.5, or 3.0 mcg/kg of PEG-Intron or placebo, administered by s/c injection once weekly. Monitoring for virologic, immunologic and safety parameters was conducted weekly.
Results: Intent-to treat data (mean values) for patients who completed the initial 4 weeks of the study prior to HAART optimization are shown in the table below. Two patients who did not receive study drug were excluded from the analysis. The 3 highest doses of PEG-Intron led to a significant decrease in HIV RNA compared to placebo. No significant change was seen in the CD4 count. Adverse events were more frequent in the 3.0 mcg/kg group and consisted primarily of fatigue, flu-like symptoms and hypertriglyceridemia.
Placebo 0.5 mcg 1.0 mcg 1.5 mcg 3.0 mcg
(n=51) (n=53) (n=51) (n=55) (n=49)
Baseline
HIV RNA 4.17 4.19 4.26 4.11 4.42
CD4 417 347 358 360 357
Wk 4 Change
HIV RNA -0.15‡ -0.25 -.043* -0.38* -.0.50*
AUC RNA -0.10‡ -0.23 -.039* -0.34* -0.46*
CD 4 -24.1‡ -1.8‡ 2.5‡ 6.4‡ 3.7‡
D/C
The 1st. IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
115
Suggested Citation
"NIETOL, et al.
ANTIVIRAL ACTIVITY AND TOLERABILITY OF PEG-INTRON IN HIV PATIENTS FAILING HAART.
Oral Presentation:
The 1st. IAS Conference on HIV Pathogenesis and Treatment
:
Abstract no.
115"
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