TY - JOUR
T1 - A phase III study of recombinant human interferon gamma to prevent opportunistic infections in advanced HIV disease
AU - Riddell, Lynn A.
AU - Pinching, A. J.
AU - Hill, Susan
AU - Ng, T. T.
AU - Arbe, E.
AU - Lapham, G. P.
AU - Ash, S.
AU - Hillman, R.
AU - Tchamouroff, S.
AU - Denning, D. W.
AU - Parkin, J. M.
PY - 2001/8/9
Y1 - 2001/8/9
N2 - The efficacy and safety of recombinant human interferon gamma (rIFN-γ) in the reduction of opportunistic disease in patients with advanced HIV-1 infection are assessed. A 12-month double-blind, placebo-controlled, multicenter, Phase III trial of rIFN-γ in HIV-positive patients with CD4 < 100 × 09/liter on stable anti-retroviral therapy. Eighty-four patients were allocated treatment on a 1:1 basis to rIFN-γ or placebo. Patients received rIFN-γ 0.05 mg/m2 or 0.9% saline subcutaneously three times weekly for 48 weeks (optional extension to 18 months). The primary end point was the incidence of opportunist infections (CDC categories B/C). Secondary end points included mortality, immunological, and virological parameters. Patients on placebo had a mean of 3.45 opportunist infections (OIs) in the first 48 weeks. Patients treated with rIFN-γ had a mean of 1.71 OIs (p = 0.04). However, the model showed overdispersion and the inclusion of a dispersion factor raised the p value to 0.13. rIFN-γ appeared to have a particular effect on the incidence of Candida, herpes simplex, and cytomegalovirus infections. Three-year survival in the rIFN-γ arm was 28% compared to 18% in the placebo group (not significant). rIFN-γ-associated side-effects of headache, fatigue, rigors, influenza-like symptoms, depression, myalgia, and granulocytopenia were reversible. There was no evidence for HIV activation. Although not significant, the trend towards decreased opportunistic infections and increased survival warrants consideration of further trials of rIFN-γ. The study gives additional information on the safety profile of this cytokine.
AB - The efficacy and safety of recombinant human interferon gamma (rIFN-γ) in the reduction of opportunistic disease in patients with advanced HIV-1 infection are assessed. A 12-month double-blind, placebo-controlled, multicenter, Phase III trial of rIFN-γ in HIV-positive patients with CD4 < 100 × 09/liter on stable anti-retroviral therapy. Eighty-four patients were allocated treatment on a 1:1 basis to rIFN-γ or placebo. Patients received rIFN-γ 0.05 mg/m2 or 0.9% saline subcutaneously three times weekly for 48 weeks (optional extension to 18 months). The primary end point was the incidence of opportunist infections (CDC categories B/C). Secondary end points included mortality, immunological, and virological parameters. Patients on placebo had a mean of 3.45 opportunist infections (OIs) in the first 48 weeks. Patients treated with rIFN-γ had a mean of 1.71 OIs (p = 0.04). However, the model showed overdispersion and the inclusion of a dispersion factor raised the p value to 0.13. rIFN-γ appeared to have a particular effect on the incidence of Candida, herpes simplex, and cytomegalovirus infections. Three-year survival in the rIFN-γ arm was 28% compared to 18% in the placebo group (not significant). rIFN-γ-associated side-effects of headache, fatigue, rigors, influenza-like symptoms, depression, myalgia, and granulocytopenia were reversible. There was no evidence for HIV activation. Although not significant, the trend towards decreased opportunistic infections and increased survival warrants consideration of further trials of rIFN-γ. The study gives additional information on the safety profile of this cytokine.
UR - http://www.scopus.com/inward/record.url?scp=0034928554&partnerID=8YFLogxK
U2 - 10.1089/088922201750251981
DO - 10.1089/088922201750251981
M3 - Article
C2 - 11429120
AN - SCOPUS:0034928554
SN - 0889-2229
VL - 17
SP - 789
EP - 797
JO - AIDS research and human retroviruses
JF - AIDS research and human retroviruses
IS - 9
ER -
