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Ratelgravir "long-term" and HIV abstract

Discussion in 'XMRV Testing, Treatment and Transmission' started by Hope123, Apr 10, 2010.

  1. Hope123

    Hope123 Senior Member

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    (Please help me get full-text! Thanks.)

    "96 weeks" is less than 2 years but ratelgravir is still very new. Of note, most long-term effects of drugs are often not known when they are released but drug companies in the US are often required to do post-market surveillance to track what happens after 5 years, 10 years, etc.

    J Acquir Immune Defic Syndr. 2010 Apr 1;53(4):456-63.
    Long-term efficacy and safety of the HIV integrase inhibitor raltegravir in patients with limited treatment options in a Phase II study.

    Gatell JM, Katlama C, Grinsztejn B, Eron JJ, Lazzarin A, Vittecoq D, Gonzalez CJ, Danovich RM, Wan H, Zhao J, Meibohm AR, Strohmaier KM, Harvey CM, Isaacs RD, Nguyen BY; Protocol 005 Team.
    Collaborators (37)
    Clumeck N, Grinsztejn B, Katlama C, Vittecoq D, Rockstroh J, Staszewski S, Carosi G, Lazzarin A, Moroni M, Lee C, Sierra J, Blanco J, Clotet B, Gatell J, Soriano V, Opravil M, Weber R, Nelson M, Aberg J, Brown S, Crumpacker C, Eron J, Gallant J, Gonzalez C, Jones-Lopez E, Swaminathan S, Kozal M, Kumar P, Kuritzkes D, Lennox J, Larsen R, Liporace R, Little S, McMahon D, Rowley M, Squires K, Tashima K.

    University of Barcelona, Barcelona, Spain.
    Abstract

    BACKGROUND: Raltegravir in combination therapy has demonstrated potent suppression of HIV-1 with a favorable safety profile. This report provides 96-week efficacy and safety data from Protocol 005, a Phase II study. METHODS: HIV-infected patients with very limited treatment options and failing antiretroviral therapy were randomized to raltegravir 200, 400, or 600 mg or placebo b.i.d., plus optimized background therapy for >or=24 weeks; all patients were then offered open-label raltegravir 400 mg b.i.d. Efficacy measurements included changes in viral load and CD4 count from baseline and percent of patients with HIV-1 RNA <400 and <50 copies/mL. RESULTS: One hundred and thirty-three patients received raltegravir and 45 received placebo. No dose-dependent differentiation in the safety or antiviral activity of raltegravir was observed during the double-blind phase. For the combined raltegravir groups, mean change in viral load from baseline was -1.60 log10 copies/mL at week 48 and -1.38 log10 copies/mL at week 96 (observed failure approach). At week 48, HIV-1 RNA levels were <400 copies/mL in 68% of raltegravir recipients and <50 copies/mL in 55%; these levels were maintained in 55% and 48% of raltegravir recipients, respectively, at week 96 (noncompleter = failure). There were few discontinuations of raltegravir (4%) due to adverse events. CONCLUSIONS: In patients with limited treatment options, raltegravir with OBT had a potent and sustained antiretroviral effect and was generally well tolerated through 96 weeks.

    PMID: 20306554 [PubMed - indexed for MEDLINE]
  2. _Kim_

    _Kim_ Guest

  3. Gerwyn

    Gerwyn Guest

  4. Hope123

    Hope123 Senior Member

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    Thanks for the article, Kim! I think the part I am most interested in is less how it affects HIV and more about the side effects portion for our purposes.

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