PMID: 8970468Dec 15, 1996Paper

Should we embrace new drugs with open arms? Experience from a community-based, open-arm, randomized clinical trial of combination antiretroviral therapy in advanced HIV disease

Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology : Official Publication of the International Retrovirology Association
J S MontanerM T Schechter

Abstract

The effect of an open arm in the enrollment to a randomized clinical trial comparing zidovudine (ZDV) plus didanosine (ddI) versus ZDV plus zalcitabine (ddC) was assessed. HIV-infected individuals were eligible to participate in this protocol if they were ddI and ddC naive, had CD4 counts of 50-350/mm3, and were residents of the province of British Columbia. Participating individuals could choose between open-label ZDV/ddI, ZDV/ddC, or randomization to open-label ZDV/ddI or ZDV/ ddC. Study drugs were made available free of charge for all participants through a centralized drug distribution system. There is no other source of these drugs in the province. Primary care physicians were required to renew the patient's prescription every 2 months. Enrollment was initiated in November 1992 and was closed in March 1994 when the randomized arm of the protocol met the predetermined target sample size of 120 evaluable participants. A total of 582 patients received combination therapy in the province through this protocol: 138 (28%) enrolled in the randomized arm and 444 (76%) in the open arm. In the latter group, 320 (72%) were initially prescribed ZDV/ddI and 124 (28%) were prescribed ZDV/ddC. The enrollment rate was strikingly higher in...Continue Reading

References

Feb 1, 1992·Controlled Clinical Trials·K Ottenbacher
May 30, 1991·The New England Journal of Medicine·E Passamani
May 30, 1991·The New England Journal of Medicine·S Hellman, D S Hellman
Mar 1, 1989·The Journal of Infectious Diseases·M Delaney
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Feb 1, 1993·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·I M Pike, C Nicaise
May 15, 1993·Annals of Internal Medicine·P D Stolley

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Citations

Nov 14, 1997·Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology : Official Publication of the International Retrovirology Association·J P IoannidisJ Lau

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