Zidovudine plus interferon-[alpha] versus zidovudine alone in HIV-infected symptomatic or asymptomatic persons with CD4+ cell counts > 150x106/l: results of the Zidon trial
Fernández-Cruz, E., Lang, J-M, Jos Frissen, P.H., Furrier, V., Châateauvert, M., Boucher, C.A.B., Dowd, P., Stevens, J. and Mallal, S. (1995) Zidovudine plus interferon-[alpha] versus zidovudine alone in HIV-infected symptomatic or asymptomatic persons with CD4+ cell counts > 150x106/l: results of the Zidon trial. AIDS, 9 (9). pp. 1025-1035.
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Objective: To evaluate the efficacy and safety of zidovudine (ZDV) and lymphoblastoid interferon (IFN)-[alpha] combination therapy compared with ZDV monotherapy in HIV-infected subjects with CD4+ cell counts between 150 and 500x106/1.
Design: Open, randomized controlled trial with subjects stratified by the Centers for Disease Control and Prevention (CDC) 1986 classification of HIV disease (group 11/111 or IV). The study was amended to a sequential design in February 1992 to allow interim analyses to be conducted.
Setting: Outpatient clinics in 45 hospitals in Europe, Australia and Canada.
Participants: A total of 402 previously untreated subjects with symptomatic HIV infection (CDC group IV) and CD4+ count 150-500xT06/1 or asymptomatic HIV infection (CDC group 11/111) with CD4+ count 150-350 x 106/l.
Interventions: ZDV 250 mg twice daily with or without 3 MU subcutaneous injections of lymphoblastoid IFN-[alpha] three times per week.
Main outcome measures: Time to development of a study endpoint defined as: progression from CDC group 11/111 to group IV, group IV non-AIDS to AIDS, or group IV AIDS to a second AIDS-defining condition; also CD4+ count to < 50x 106/1 on two occasions at least 1 month apart or HIV-related death irrespective of CDC group on entry.
Results: There was no reduction in the rate of disease progression for patients receiving ZDV plus IFN-[alpha] compared with patients receiving ZDV alone. No major differences between the groups were seen for CD4+ counts or percentages, or p24 antigenaemia. In a subset of 70 patients, a similar proportion from both dose groups showed evidence of ZDV resistance after 48 weeks of treatment. More adverse experiences were seen in the ZDV/IFN-a group.
Conclusions: Combination therapy with low dose lymphoblastoid IFN-[alpha] and ZDV revealed no clinical benefit compared with ZDV monotherapy.
|Publication Type:||Journal Article|
|Publisher:||Lippincott Williams & Wilkins Ltd.|
|Copyright:||(C) 1995 Lippincott-Raven Publishers|
|Notes:||Simon Mallal appears as part of the Zidon Study Group|
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