ZIDOVUDINE PLUS INTERFERON-ALPHA VERSUS ZIDOVUDINE ALONE IN HIV-INFECTED SYMPTOMATIC OR ASYMPTOMATIC PERSONS WITH CD4-THAN-150X10(6)( CELL COUNTS GREATER)I - RESULTS OF THE ZIDON TRIAL/

Authors
FERNANDEZCRUZ E LANG JM FRISSEN J FURNER V CHATEAUVERT M BOUCHER CAB DOWD P STEVENS J GOLD J MICHELMORE H BENSON E SPELMAN E HOY J WRIGHT E FRENCH M HUDSON J MALLAL S BODSWORTH N STINGL G MAYERHOFER S KRONAWETTER M TSOUKAS C SZABO T KATLAMA C GUERMONPREZ G RAFFI F BILLAUD E MILPIED B BOURGEOT V FLEISHMANN M BARRIER JH DELZANT G WINTER C MEHARZI J TREPO C COTTE L ROUGIER P HASSAIRI N CHOUTET P BESNIER JM LAFEUILLADE A RASOKAT H GROSS G MAUSCH HE STRATIGOS J POLYDOROV D STAVRIANEAS N KIOSSES V MANDALAKI T KARAFOULIDOU A KARABINIS A STERGIOU G PLOUMIDES G PITSAS A TASSOPOULOS N KOUTSOUNOPOULOS G HATZAKIS A MORONI M DARMINIO A BINI T CHIODO F COLANGELI V RICCHI E AIUTI F FERRARA R MEZZAROMA I LANGE JMA FRISSEN PHJ SPRENGER HG KROON FP VANDERENDE ME DEMARIE S KOOPMANS PP DOLMANS WMV SCHREIJ GS WEIGEL HM TENNAPEL CHH TENKATE RW MARANON G ZABAY JM COSIN J PENA JM RUBIO R RIBERA E VAZQUEZ JMM LEAL M ANDREU J CARTON JA ASENSI V GOMEZTRUJILLO F ORIHUELA F SERRANO C FERRER E MANDAL BK JOHNSON M MCKARTHY K FARMER D TANG A MITCHELL SA BROWN J TOORAWA R YEO J
Citation
E. Fernandezcruz et al., ZIDOVUDINE PLUS INTERFERON-ALPHA VERSUS ZIDOVUDINE ALONE IN HIV-INFECTED SYMPTOMATIC OR ASYMPTOMATIC PERSONS WITH CD4-THAN-150X10(6)( CELL COUNTS GREATER)I - RESULTS OF THE ZIDON TRIAL/, AIDS, 9(9), 1995, pp. 1025-1035
Citations number
36
Categorie Soggetti
Immunology,"Infectious Diseases
Journal title
AIDS → ACNP
ISSN journal
02699370
Volume
9
Issue
9
Year of publication
1995
Pages
1025 - 1035
Database
ISI
SICI code
0269-9370(1995)9:9<1025:ZPIVZA>2.0.ZU;2-9
Abstract
Objective: To evaluate the efficacy and safety of zidovudine (ZDV) and lymphoblastoid interferon (IFN)-alpha combination therapy compared wi th ZDV monotherapy in HIV-infected subjects with CD4+ cell counts betw een 150 and 500 x 10(6)/l. Design: Open, randomized controlled trial w ith subjects stratified by the Centers for Disease Control and Prevent ion (CDC) 1986 classification of HIV disease (group II/III or IV). The study was amended to a sequential design in February 1992 to allow in terim analyses to be conducted. Setting: Outpatient clinics in 45 hosp itals in Europe, Australia and Canada. Participants: A total of 402 pr eviously untreated subjects with symptomatic HIV infection (CDC group IV) and CD4+ count 150-500x10(6)/l or asymptomatic HIV infection (CDC group II/III) with CD4+ count 150-350 x 10(6)/l. Interventions: ZDV 25 0 mg twice daily with or without 3 MU subcutaneous injections of lymph oblastoid IFN-alpha three times per week. Main outcome measures: Time to development of a study endpoint defined as: progression from CDC gr oup II/III to group IV, group IV non-AIDS to AIDS, or group IV AIDS to a second AIDS-defining condition; also CD4+ count to <50 x 10(6)/l on two occasions at least 1 month apart or HIV-related death irrespectiv e of CDC group on entry. Results: There was no reduction in the rate o f disease progression for patients receiving ZDV plus IFN-alpha compar ed 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 group s showed evidence of ZDV resistance after 48 weeks of treatment. More adverse experiences were seen in the ZDV/IFN-alpha group. Conclusions: Combination therapy with low dose lymphoblastoid IFN-alpha and ZDV re vealed no clinical benefit compared with ZDV monotherapy.