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Gulick, R.M. et al.

Gulick, Hu, Fiscus, Fletcher, Haubrich, Cheng, Acosta, Lagakos, Swanstrom, Freimuth, Snyder, Mills, Fischl, Pettinelli, Katzenstein,

Randomized study of saquinavir with ritonavir or nelfinavir together with delavirdine, adefovir, or both in human immunodeficiency virus-infected adults with virologic failure on indinavir: AIDS Clinical Trials Group Study 359.

This study compared antiretroviral activity among 6 "salvage" therapy regimens. The study was a prospective, randomized, 2x3 factorial, multicenter study of the AIDS Clinical Trials Group. The study enrolled 277 human immunodeficiency virus (HIV)-infected patients naive to nonnucleoside analogues who had taken indinavir >6 months. The patients had 2000-200,000 HIV RNA copies/mL. Patients received saquinavir with ritonavir or nelfinavir together with delavirdine and/or adefovir and were followed for safety and antiretroviral response between baseline and week 16. At week 16, 30% (77/254) of patients had </=500 HIV RNA copies/mL. Virologic response did not differ significantly between pooled ritonavir and nelfinavir groups (28% vs. 33%; P=.50) or between pooled delavirdine and delavirdine/adefovir groups (40% vs. 33%; P=.42). Pooled delavirdine groups had a greater virologic response rate than did adefovir groups (40% vs. 18%; P=.002). Overall, one-third of patients who experienced virologic failure on an indinavir-containing regimen suppressed virus load levels while they were taking a new salvage regimen.[1]

References

Randomized study of saquinavir with ritonavir or nelfinavir together with delavirdine, adefovir, or both in human immunodeficiency virus-infected adults with virologic failure on indinavir: AIDS Clinical Trials Group Study 359. Gulick, R.M., Hu, X.J., Fiscus, S.A., Fletcher, C.V., Haubrich, R., Cheng, H., Acosta, E., Lagakos, S.W., Swanstrom, R., Freimuth, W., Snyder, S., Mills, C., Fischl, M., Pettinelli, C., Katzenstein, D. J. Infect. Dis. (2000) [Pubmed]

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