135
Views
12
CrossRef citations to date
0
Altmetric
Original Articles

Causes and Consequences of Incomplete HIV RNA Suppression in Clinical Trials

, , , &
Pages 289-298 | Published online: 06 Jan 2015

REFERENCES

  • Hammer S, Eron J, Reiss P, et al. Antiretroviral treat-ment of Adult HIV infection. 2008 recommendations of the International AIDS Society-USA panel. JAMA. 2008;300(5):555–570.
  • Gazzard BG, on behalf of the BHIVA Treatment Guide-lines Writing Group. British HIV Association guidelines for the treatment of HIV-1 infected adults with antiretroviral therapy 2008. HIV Med. 2008;9:563–608.
  • Roche Diagnostics GmbH, Manhheim, Germany. COBAS Amplicor HIV-1 MONITOR Test, version 1.5. June 2007, Package Insert. Available at: http://www.fda.gov/Cber/sba/hiv1roc122002S.htm. Accessed September 2008.
  • Lima V, Harrigan R, Montaner J. Increased reporting of detectable plasma HIV-1 RNA levels at the critical thresh-old of 50 copies per milliliter with the Taqman assay in comparison to the Amplicor assay. J Acquir Immune Defic Syndr 2009;51(1):3–6.
  • Maldarelli F, Palmer S, King M, et al. ART suppresses plasma HIV-1 RNA to a stable set point predicted by pre-therapy viraemia. PLos Pathogens. 2007;3(4):e46.
  • Gandhi R, Zheng S, Bosch R, Chan E, Margolis D, Read S. Raltegravir (RAL) intensification does not reduce low-level residual viremia in HIV-1-infected patients on antiretroviral therapy (ART): results from ACTG A5244. In: Program and abstracts from the Fifth Conference on HIV Pathogenesis, Treatment and Prevention; Cape Town, South Africa. Abstract WELBB104.
  • Nettles RE, Kieffer TL, Kwon P, et al. Intermittent HIV-1 viremia (blips) and drug resistance in patients receiving HAART. JAMA. 2005;293(7):817–829.
  • Garcia-Gasco P, Maida I, Blanco F, et al. Episodes of low-level viral rebound in HIV-infected patients on antiretroviral therapy: frequency, predictors and outcome. J Antimicrob Chemother 2008;61:699–704.
  • Karlsson A, Younger S, Martin J, et al. Immunologic and virologic evolution during periods of intermittent and per-sistent low-level viraemia. AIDS. 2004;18(7):891–989.
  • Percus JK, Percus OE, Markowitz M, et al. The distribution of viral blips observed in HIV-1 infected patients treated with combination antiretroviral therapy. Bull Math Biol. 2003;65(2):263–277.
  • Di Mascio M, Percus JK, Percus OE, Markowitz M, Ho DD, Perelson AS. Duration of an intermittent episode of viremia. Bull Math Biol. 2005;67(4):885–900.
  • Staszewski S, Sabin C, Dauer B, Lepri A, Phillips A. Defini-tion of loss of virological response in trials of antiretroviral drugs. AIDS. 2003;17:1997–1998.
  • Havlir D, Bassett R, Levitan D, et al. Prevalence and pre-dictive value of intermittent viremia with combination HIV therapy. JAMA. 2001;286:171–179.
  • Greub G, Cozzi-Lepri A, Ledergerber B, et al. Intermit-tent and sustained low-level HIV viral rebound in patients receiving potent antiretroviral therapy. AIDS. 2002;16: 1967–1969.
  • Damond F, Roquebert B, Bénard A, et al. Human immu-nodeficiency virus type 1 (HIV-1) plasma load discrep-ancies between the Roche COBAS AMPLICOR HIV-1 MONITOR version 1.5 and the Roche COBAS AmpliPrep/ COBAS TaqMan HIV-1 assays. J Clin Microbiol. 2007;45: 3436–3438.
  • Gueudin M, Plantier J, Lemee V, et al. Evaluation of the Roche COBAS TaqMan and Abbott RealTime Extraction-Quantification Systems for HIV-1 subtypes. J Acquir Immun Defic Syndr 2007;44:500–505.
  • Walmsley S, Ruxrungtham K, Slim J, Ward D, Larson P, Raffi F. The Gemini Study saquinavir/r (SQV/r) vs lopinavir/r (LPV/r) plus emtricitabine/tenofovir (FTC/TDF) as ini-tial therapy in HIV-1 infected patients. In: Program and abstracts from the European AIDS Clinical Society Confer-ence; October 2007; Madrid, Spain. Abstract PS1/4.
  • Gathe J, daSilva B, Loufty M, et al. Study M05-730 pri-mary efficacy results at week 48: phase 3, randomized, open-label study of lopinavir-ritonavir (LPV/r) tablets once-daily (OD) versus twice-daily (BID), co-administered with tenofovir (TDF) + emtricitabine (FTC) in antiretroviral naïve (ARV) HIV-1 infected subjects. In: Program and abstracts from the 15th Conference on Retroviruses and Opportunistic Infections (CR01); February 2008; Boston, MA. Abstract 775.
  • Cooper D, et al. Efficacy and safety of two doses of tipra-navir/ritonavir versus lopinavir/ritonavir-based therapy in antiretroviral-naïve patients: results of B11182.33. In: Pro-gram and abstracts from the Eighth International Congress on Drug Therapy in HIV Infection; Glasgow; 2006. Abstract PL13.4.
  • Riddler S, Haubrich R, DiRienzo A, et al, ACTG Study 5142 Team. Class-sparing regimens for initial treatment of HIV-1 infection. New Eng J Med. 2008;358(20):2095–2106.
  • Gupta R, Hill A, Sawyer A, Pillay D. Emergence of drug resistance in HIV type 1-infected patients after receipt of first-line highly active antiretroviral therapy: a sys-tematic review of clinical trials. Clin Infect Dis. 2008;47: 712–722.
  • Von Wyl V, Yerly S, Boni S, et al. Emergence of HIV-1 drug resistance in previously untreated patients initiat-ing combination antiretroviral therapy. A comparison of different regimen types. Arch Intern Med. 2007;167(16): 1782–1790.
  • US Department of Health and Human Services, Food and Drug Administration and Center for Drug Evaluation and Research. Guidance for industry: antiretroviral drugs using plasma HIV RNA measurements-clinical consider-ations for accelerated and traditional approval. Available at: http://www.fda.gov/CDER/GUIDANCE/3647fnI.pdf. Accessed August 15, 2007.
  • Molina J, Andrade-Villanueva J, Echevarria J, et al. Efficacy and safety of once-daily atazanavir-ritonavir compared to twice daily lopinavir-ritonavir, each in combination with tenofovir and emtricitabine in ARV-naïve HIV-1 infected subjects: the CASTLE study, 48 week results. In: Program and abstracts from the 15th Conference on Retroviruses and Opportunistic Infections (CR01); February 2008; Boston, MA. Abstract 37.
  • Gulick RM, Ribaudo HJ, Shikuma CM, et al. Triple-nucleoside regimens versus efavirenz-containing regimens for the initial treatment of HIV-1 infection. N Engl J Med. 2004;350(18)1 850–1861.
  • Cane P, Kaye S, Smit E, et al. Genotypic antiretroviral drug resistance testing at low viral loads in the UK. HIV Med. 2008;9:673–676.
  • Pozniak A, Gazzard B, Yehya M, Pillay D, Wildfire A, Cox A. Evidence of low-level replication (<50 copies/mL) predicts eventual virologic failure. In: Program and abstracts from the 10th Conference on Retroviruses and Opportunistic Infections; February 2006; Denver, CO. Abstract 576.
  • DeJesus E, Herrera G, Teofilo E, et al. Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral naïve HIV infected adults. Clin Infect Dis. 2004;39:1038–1046.
  • Moyle G, DeJesus E, Cahn P, et al. Abacavir once or twice daily combined with once-daily lamivudine and efavirenz for the treatment of antiretroviral naive HIV-infected patients. J Acquir Immune Defic Syndr. 2005;38: 417–425.
  • Gallant JE, Staszewski S, Pozniak AL, et al. Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial. JAMA. 200;292(2)1 91–201.
  • Emitricabine (Emitriva, FTC) US prescribing information. Gilead Sciences Inc; July 2003. www.emtriva.com.
  • Galant J, DeJesus E, Arribas J, et al. Tenofovir DF, emtric-itabine and efavirenz vs zidovudine, lamivudine and efa-virenz for HIV. N Engl J Med. 2006;354:251–260.
  • De Jesus E, McCarty D, Farthing CF, et al. Once-daily versus twice-daily lamivudine, in combination with zidovu-dine and efavirenz, for the treatment of antiretroviral-naive adults with HIV infection: a randomized equivalence trial. Clin Infect Dis. 2004; 39 (3):411–418.
  • Saag M, Lye P, Heera J, et al. A multicentre, randomised, double-blind, comparative trial of a novel CCR5 antago-nist, maraviroc versus efavirenz, both in combination with Combivir (zidovudine [ZDV]/Iamivudine [3TC]), for the treatment of antiretroviral naive patients infected with R5 HIV1; Week 48 results of the MERIT Study. In: Program and abstracts from the Fourth IAS Conference on HIV Pathogenesis, Treatment and Prevention; July 2007; Syd-ney, Australia. Abstract WESS104.
  • Ortiz R, DeJesus E, Khanlou H, et al. Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir-ritonavir in treatment naive HIV-1 infected patients at Week 48. AIDS. 2008;22:1389–1397.
  • Smith K, Fine D, Patel P, et al. Efficacy and safety of abacavir/lamivudine compared to tenofovir/emtricitabine in combination with once-daily lopinavir-ritonavir through 48 weeks in the HEAT study. In: Program and abstracts from the 15th Conference on Retroviruses and Oppor-tunistic Infections (CR01); February 2008; Boston, MA. Abstract 774.
  • Eron J, Yeni P, Gathe J, et al. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, or initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial. Lancet. 2006;368:476–482.
  • Walmsley S, Bernstein B, King M, et al. Lopinavir-ritonavir versus nelfinavir for the initial treatment of HIV infection. N Engl J Med. 2002;346(26):2039–2046.
  • Gathe J, Lye P, Wood R, et al. SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir/ritonavir versus twice-daily nelfinavir in naïve HIV-1 infected patients. AIDS. 2004;18:1529–1537.
  • Malan N, Krantz E, Neal D, Kastango K, Frederick D, Mathew M. Efficacy and safety of atazanavir with and without ritonavir in antiretroviral-naïve subjects. BM5089: 48-week results. In: Program and abstracts from the 13th Conference on Retroviruses and Opportunistic Infections; February 5–8, 2006; Denver, CO.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.