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COMBINATION AND MONOTHERAPY WITH ZIDOVUDINE AND ZALCITABINE IN PATIENTS WITH ADVANCED HIV DISEASE

Authors

FISCHL MA STANLEY K COLLIER AC ARDUINO JM STEIN DS FEINBERG JE ALLAN JD GOLDSMITH JC POWDERLY WG RAINES CP MAYJO KJ KERULY JC CRAVEN D HIRSHORN L HIRSCH MS JAYAWEERA DT YOUNG SW PATRONEREESE J BRETTLER D SPERBER K GERITS P SEREMETIS S GILL JC GELB LD MCGUIRE ML STIFFLER T LEDERMAN MM CAREY JT WALLACE M MACARTHUR RD BERGE P MILDVAN D COREY L COOMBS RW CUMMINGS DK SCHOOLEY RT RAY MG WAITE V KURITZKES DR FUHRER J TENZLER RJ DONLON W VANDERHORST CM TROIANI L HORTON J LANE TW MURPHY RR PHAIR JP KESSLER HA BENSON CA ROSENWALD V YONREN S VALENTINE F HASLETT P MITSUYASU RT GUERRO M GOETZ MB MATHISEN GE FRAME PT BRINKDOPKE J POWELL T HOELLE M MERIGAN TC SHAFER R CAIN P FESSELL J HENRY K RHAME F CHRISTENSON J STRYKE D ZINGMAN B KAHL P SOEIRO R CHOI YS REICHMAN RL REID J BLAIR DC STEIGBIGEL RT HEWITT RG CAMERON ML DONNELLY MA PACKARD MV BARTLETT JA FIFE KH ZWICKL BW BORUM J BURACK JH DYBECK KA COLEMAN RL JOHNSON WR MCKINLEY GF GRIECO MH KOLATCH BR SEPKOWITZ K PONTICELLO L GIORDANO MF MURRAY HW GOCKE DJ FASS RJ PARA MF STERN JS DREW LJ SPECTOR SA HAVLIR DV NUFFER KL RICHMAN DD CONNOR EM KLOSER PC PICARDI JM VANMATERMINER C LEEDOM JM HOLTOM PD RICHARDSON W EHMANN WC ZURLO JJ KREHER M EYSTER ME HYSLOP NE MUSHATT DM HOADLEY DJ ZACHARY JA SIMON GL PARENTI DM LELACHEUR S SCHUCK S HO MT MCMAHON DK PAZIN GJ ROSENER R CHEESEMAN SH MANGINI LA SANDS MG KAZIAL K JONES G PETTINELLI CB LANDRY B MARTINEZ AI

Citation

Ma. Fischl et al., COMBINATION AND MONOTHERAPY WITH ZIDOVUDINE AND ZALCITABINE IN PATIENTS WITH ADVANCED HIV DISEASE, Annals of internal medicine, 122(1), 1995, pp. 24-32

Citations number

Categorie Soggetti

Medicine, General & Internal

Journal title

Annals of internal medicine → ACNP

ISSN journal

00034819

Volume

122

Issue

Year of publication

1995

Pages

24 - 32

Database

ISI

SICI code

0003-4819(1995)122:1<24:CAMWZA>2.0.ZU;2-F

Abstract

Objective: To compare the safety and efficacy of continuing zidovudine therapy with that of zalcitabine alone or zalcitabine and zidovudine used together. Design: A randomized, double-blind, controlled trial. S etting: AIDS Clinical Trials units and National Hemophilia Foundation sites. Patients: 1001 patients with symptomatic human immunodeficiency (HIV) disease and 300 or fewer CD4 cells/mm(3) or asymptomatic HIV di sease and 200 or fewer CD4 cells/mm(3) who had tolerated zidovudine th erapy for 6 months or more. Intervention: Patients were randomly assig ned to receive zidovudine, 600 mg/d; zalcitabine, 2.25 mg/d; or zidovu dine, 600 mg/d, and zalcitabine, 2.25 mg/d. Measurements: The primary end point was time to disease progression or death. Results: The media n follow-up time was 17.7 months. The estimated 72-month event-free ra tes were 70%, 67%, and 73%, respectively, for the zidovudine, zalcitab ine, and combination groups (P = 0.26). A trend analysis showed signif icantly lower progression rates for combination therapy compared with zidovudine therapy as the pretreatment CD4 cell count increased (P = 0 .027). For patients with 150 or more CD4 cells/ mm(3), those receiving combination therapy were less likely to have disease progression or t o die than were those receiving zidovudine (relative risk, 0.51; 95% C l, 0.28 to 0.93; P = 0.029). We observed no difference between the zal citabine and zidovudine groups (relative risk, 0.74; Cl, 0.40 to 1.36; P = 0.33). For patients with 50 to 150 CD4 cells/mm(3) or fewer than 50 CD4 cells/mm(3), we found no differences among the treatment groups (P = 0.69 and P = 0.57, respectively). Severe toxic effects occurred less frequently among patients with 150 or more CD4 cells/mm(3). Concl usions: We found no overall benefits of zalcitabine used alone or with zidovudine. However, a trend analysis suggested a better outcome for combination therapy compared with zidovudine as the pretreatment CD4 c ell count increased.