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Clinical Trial
. 2010 Feb 15;50(4):605-12.
doi: 10.1086/650002.

Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials

Roy T Steigbigel  1 , David A Cooper, Hedy Teppler, Joseph J Eron, Jose M Gatell, Princy N Kumar, Jurgen K Rockstroh, Mauro Schechter, Christine Katlama, Martin Markowitz, Patrick Yeni, Mona R Loutfy, Adriano Lazzarin, Jeffrey L Lennox, Bonaventura Clotet, Jing Zhao, Hong Wan, Rand R Rhodes, Kim M Strohmaier, Richard J Barnard, Robin D Isaacs, Bach-Yen T Nguyen; BENCHMRK Study Teamsa
Collaborators, Affiliations
Clinical Trial

Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials

Roy T Steigbigel et al. Clin Infect Dis. .

Abstract

BENCHMRK-1 and -2 are ongoing double-blind phase III studies of raltegravir in patients experiencing failure of antiretroviral therapy with triple-class drug-resistant human immunodeficiency virus infection. At week 96 (combined data), raltegravir (400 mg twice daily) plus optimized background therapy was generally well tolerated, with superior and durable antiretroviral and immunological efficacy, compared with optimized background therapy alone.

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Conflict of interest statement

Potential conflicts of interest. R.T.S. has received research support, speaker fees, and/or consulting fees from Merck. D.A.C. has received research support, speaker fees, and/or consulting fees from Merck. J.J.E. has received research support from Merck, Abbott, and Panacos and speaker fees and/or consulting fees from Merck, BMS, GSK, Gilead, Tibotec, Roche, and Pfizer. J.M.G. has received research support, speaker fees, and consulting fees from Merck. P.N.K. has been an investigator for Merck and GSK; has been a paid consultant to Boehringer-Ingelheim, BMS, GSK, and Tibotec; and has received speaker fees from GSK, Abbott, Tibotec, Pfizer, and Boehringer-Ingelheim. J.K.R. has received honoraria for lectures or advisory boards from Merck, Roche, GSK, BMS, Tibotec, Pfizer, Gilead, Abbott, and Boehringer Ingelheim. C.K. has received honoraria for advisory boards or lectures from Merck, Gilead, Roche, GSK, Tibotec, BMS, and Boehringer Ingelheim. M.M. has received research support, speaker fees, and/or consulting fees from Merck. P.Y. has received consulting fees from Merck. M.R.L. has received research support from Merck. A.L. has received honoraria for lectures or advisory board meetings and/or research support from Merck, GSK, BMS, Gilead, Roche, Tibotec, Pfizer, Boehringer-Ingelheim, Abbott, Monogram, and Schering-Plough. J.L.L. has received research support and speaker’s fees from Merck and serves on Merck’s antiretroviral scientific advisory board. B.C. has been a consultant on advisory boards, has participated in speakers’ bureaus, or has conducted clinical trials with Roche, Boehringer-Ingelheim, Abbott, BMS, GSK, Gilead, Tibotec, Janssen, Merck, Pfizer, Siemens, Monogram Biosciences, and Panacos. H.T., M.S., H.W., R.R.R., K.M.S., R.J.B., R.D.I., and B.-Y.T.N.are employees of Merck Research Laboratories and may own stock and/or stock options in the company.

Figures

Figure 1.
Figure 1.
A, Percentage of patients with a plasma HIV RNA level <50 copies/mL, over time, by treatment group. B, Percentage of patients with a plasma HIV RNA level <400 copies/mL, over time, by treatment group. The proportion of patients with an HIV RNA level below the limit of quantification for the ultrasensitive assay and the standard assay, respectively, are shown; patients who did not complete the study were counted as treatment failures. C, Change from baseline in CD4 cell count, over time, by treatment group. The mean change in CD4 cell count per mm3 from baseline are shown using the observed failure approach, carrying baseline values forward (thereby assigning a value of 0 to change from baseline) for all treatment failures. Vertical brackets represent the 95% confidence intervals. OBT, optimized background therapy.
Figure 2.
Figure 2.
Proportion of patients with an HIV RNA level <50 copies/mL at week 96, by subgroup. Filled circles represent the point estimate of the between-group differences; horizontal bars represent the corresponding 95% confidence intervals (CIs). The vertical line at zero is provided as a reference indicating no treatment difference. Dar, darunavir; Enf, enfuvirtide; GT, genotypic test; OBT, optimized background therapy; PT, phenotypic test; TPV, tipranavir. **Median age, 45 years.
Figure 3.
Figure 3.
Change in CD4 cell count from baseline to week 96, by subgroup. Filled circles represent the point estimate of the between-group differences; horizontal bars represent the corresponding 95% confidence intervals (CIs). The vertical line at zero is provided as a reference indicating no treatment difference. Dar, darunavir; Enf, enfuvirtide; GT, genotypic test; OBT, optimized background therapy; PT, phenotypic test; TPV, tipranavir. **Median age, 45 years.
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