Comparison of central and local HIV-1 RNA quantification from two international clinical trials

Janaki Amin; Matthew G. Law; Rebekah Puls; Anthony Kelleher; David A. Cooper; Sean Emery

doi:10.1097/QAD.0000000000000461

Comparison of central and local HIV-1 RNA quantification from two international clinical trials

Janaki Amin^*, Matthew G. Law, Rebekah Puls, Anthony Kelleher, David A. Cooper, Sean Emery

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

Local and centrally measured plasma HIV RNA (pVL) were assessed for agreement in two trials, ENCORE1 and SECOND-LINE. The proportion less than 200 copies/ml at week 48 was qualitatively similar [ENCORE1 2.5% (95% confidence interval, 95% CI-1.6 to 6.6); 1.9% (95% CI-1.9 to 2.1); SECOND-LINE 0.3% (95% CI-6.4 to 10.0); 1.8% (95% CI-4.7 to 8.3)]. The mean difference in log10 pVL copies/ml at weeks 0 and 48 was less than 0.2 log₁₀ copies/ml in both trials. Our data indicate that central testing of pVL in HIV therapeutic trials is not warranted.

Original language	English
Pages (from-to)	2480-2483
Number of pages	4
Journal	AIDS
Volume	28
Issue number	16
DOIs	https://doi.org/10.1097/QAD.0000000000000461
Publication status	Published - 23 Oct 2014
Externally published	Yes

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title = "Comparison of central and local HIV-1 RNA quantification from two international clinical trials",

abstract = "Local and centrally measured plasma HIV RNA (pVL) were assessed for agreement in two trials, ENCORE1 and SECOND-LINE. The proportion less than 200 copies/ml at week 48 was qualitatively similar [ENCORE1 2.5% (95% confidence interval, 95% CI-1.6 to 6.6); 1.9% (95% CI-1.9 to 2.1); SECOND-LINE 0.3% (95% CI-6.4 to 10.0); 1.8% (95% CI-4.7 to 8.3)]. The mean difference in log10 pVL copies/ml at weeks 0 and 48 was less than 0.2 log10 copies/ml in both trials. Our data indicate that central testing of pVL in HIV therapeutic trials is not warranted.",

author = "Janaki Amin and Law, {Matthew G.} and Rebekah Puls and Anthony Kelleher and Cooper, {David A.} and Sean Emery",

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T1 - Comparison of central and local HIV-1 RNA quantification from two international clinical trials

AU - Amin, Janaki

AU - Law, Matthew G.

AU - Puls, Rebekah

AU - Kelleher, Anthony

AU - Cooper, David A.

AU - Emery, Sean

PY - 2014/10/23

Y1 - 2014/10/23

N2 - Local and centrally measured plasma HIV RNA (pVL) were assessed for agreement in two trials, ENCORE1 and SECOND-LINE. The proportion less than 200 copies/ml at week 48 was qualitatively similar [ENCORE1 2.5% (95% confidence interval, 95% CI-1.6 to 6.6); 1.9% (95% CI-1.9 to 2.1); SECOND-LINE 0.3% (95% CI-6.4 to 10.0); 1.8% (95% CI-4.7 to 8.3)]. The mean difference in log10 pVL copies/ml at weeks 0 and 48 was less than 0.2 log10 copies/ml in both trials. Our data indicate that central testing of pVL in HIV therapeutic trials is not warranted.

AB - Local and centrally measured plasma HIV RNA (pVL) were assessed for agreement in two trials, ENCORE1 and SECOND-LINE. The proportion less than 200 copies/ml at week 48 was qualitatively similar [ENCORE1 2.5% (95% confidence interval, 95% CI-1.6 to 6.6); 1.9% (95% CI-1.9 to 2.1); SECOND-LINE 0.3% (95% CI-6.4 to 10.0); 1.8% (95% CI-4.7 to 8.3)]. The mean difference in log10 pVL copies/ml at weeks 0 and 48 was less than 0.2 log10 copies/ml in both trials. Our data indicate that central testing of pVL in HIV therapeutic trials is not warranted.

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Comparison of central and local HIV-1 RNA quantification from two international clinical trials

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