Issues in the design of trials of therapies for subjects with Human Immunodeficiency Virus infection that use plasma RNA level as an outcome

1997 | Journal of Infectious Diseases

Program(s): AIDS Research Program |

http://www.ncbi.nlm.nih.gov/pubmed/9041328

Abstract:

Longitudinal plasma RNA levels were examined in 326 persons infected with human immunodeficiency virus (HIV), who were participating in 4 clinical trials and 1 observational study. Variations in plasma RNA levels among individuals were analyzed, and correlations were made of replicate and longitudinal measurements, plasma RNA levels, CD4 cell counts, and plasma RNA levels at enrollment. Sample sizes were calculated for detection of differences between treatment groups in mean plasma RNA level at one time point, the average change over time, and the area under the curve. On the basis of study findings, study eligibility criteria should specify a minimum plasma RNA level at least as high as the expected size of the treatment effect, and all longitudinal data should be used when determining the effect of treatment on plasma RNA level. Duplicating plasma RNA levels resulted in a decrease in the required sample size of 14%-41%.

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Raboud JM

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© Copyright BC Centre for Excellence in HIV/AIDS
St. Paul's Hospital 608–1081 Burrard Street, Vancouver, BC, Canada V6Z 1Y6
Tel: 604-806-8477 | Fax: 604-806-9044
General inquiries: info@bccfe.ca
Media inquiries: communications@bccfe.ca
(Please do not use any of these email addresses to send personal information or book an appointment. To book appointments or contact the H2H clinic, please call 604-416-1517 or fax: 604-564-4893. Do not send your or your client's personal information via email.)

Our work serves clients and communities across British Columbia on lands and waters cared for and nurtured by the many distinct First Nations across the province. The BC-CfE humbly and gratefully acknowledge the stewards of these lands, particularly the xʷməθkʷəy̓əm (Musqueam), Sḵwx̱wú7mesh (Squamish), and səl̓ílwətaʔ (Tsleil-Waututh) on whose unceded, traditional and ancestral territories our offices are located.