| Author | Tan, Darrell H S | pt_BR |
| Author | Raboud, Janet M | pt_BR |
| Author | Szadkowski, Leah | pt_BR |
| Author | Grinsztejn, Beatriz | pt_BR |
| Author | Madruga, José Valdez Ramalho | pt_BR |
| Author | Figueroa, Maria Ines | pt_BR |
| Author | Cahn, Pedro | pt_BR |
| Author | Barton, Simon E | pt_BR |
| Author | Clarke, Amanda | pt_BR |
| Author | Fox, Julie | pt_BR |
| Author | Zubyk, Wendy | pt_BR |
| Author | Walmsley, Sharon L | pt_BR |
| Author | VALIDATE Study Group | pt_BR |
| Access date | 2018-12-05T17:21:48Z | |
| Available date | 2018-12-05T17:21:48Z | |
| Document date | 2018 | |
| Citation | TAN, D. H. S. et al. Effect of valaciclovir on CD4 count decline in untreated HIV: an international randomized controlled trial. J Antimicrob Chemother, 2018. | pt_BR |
| ISSN | 0305-7453 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/30406 | |
| Description | VALIDATE Study Team are: Jason Brunetta (Maple Leaf Medical Clinic. Toronto); William Cameron (The Ottawa Hospital. Ottawa); Jeff Cohen (Windsor Regional Hospital. Windsor, Canada); Brian Conway (Downtown ID Clinic. Vancouver, Canada); Claude Fortin (Centre Hospitalier de l’Université de Montréal. Montreal, Canada); Chris Fraser (Cool Aid Community Health Centre. Victoria, Canada); Don Kilby (University of Ottawa Health Services. Ottawa, Canada); Marina Klein (McGill University Health Centre. Montreal, Canada); Ken Logue (St. Clair Medical Associates. Toronto, Canada); Neora Pick (Oak Tree Clinic. Vancouver, Canada); Anita Rachlis (Sunnybrook Hospital. Toronto, Canada); Barbara Romanowski (University of Alberta. Edmonton, Canada); Fiona Smaill (Hamilton Health Sciences Centre. Hamilton, Canada); Sylvie Trottier (Centre Hospitalier Universitaire de Quebec. Quebec City, Canada); Alan Winston (St Mary’s Hospital. London, UK). | pt_BR |
| Language | eng | pt_BR |
| Publisher | Oxford | pt_BR |
| Rights | restricted access | pt_BR |
| Title | Effect of valaciclovir on CD4 count decline in untreated HIV: an international randomized controlled trial | en_US |
| Type | Article | |
| DOI | 10.1093/jac/dky433 | |
| Abstract | Objectives: To determine the impact of valaciclovir on HIV disease progression in treatment-naive HIV-positive adults. Methods: In this fully blind, multicentre, 1:1 randomized placebo-controlled trial, treatment-naive HIV-1-positive adults with CD4 counts 400–900 cells/mm3 and not meeting contemporaneous recommendations for combination ART (cART) were randomized to valaciclovir 500 mg or placebo twice daily, and followed quarterly until having two consecutive CD4 counts 350 cells/mm3 or initiating cART for any reason. The primary analysis compared the rate of CD4 count decline by study arm after adjusting for baseline CD4 count and viral load (VL). Secondary analyses compared the rate of CD4 percentage decline, HIV VL, herpes simplex virus (HSV) recurrences and drug-related adverse events. The trial closed after release of the START trial results in August 2015. Results: We enrolled 198 participants in Canada, Brazil, Argentina and the UK. Median (IQR) age was 35 (30–43) years. Baseline CD4 count was 592 (491–694) cells/mm3 and VL was 4.04 (3.5–4.5) log10 copies/mL. Over 276 person-years of follow-up, CD4 counts declined by 49 cells/mm3/year in the valaciclovir arm versus 58 cells/mm3/year in the placebo arm (P " 0.65). No differences were seen in the rate of change in CD4 percentage (#1.2%/year versus #1.7%/year, P " 0.34). VL was 0.27 log10 copies/mL lower in valaciclovir participants overall (P,0.001). Placebo participants had more HSV recurrences (62 versus 21/100 person-years, P , 0.0001) but similar rates of grade 2 drug-related adverse events. Conclusions: Unlike prior trials using aciclovir, we found that valaciclovir did not slow CD4 count decline in cARTuntreated adults, although power was limited due to premature study discontinuation. Valaciclovir modestly lowered HIV VL. | en |
| Affilliation | St. Michael's Hospital. Division of Infectious Diseases. Centre for Urban Health Solutions. Toronto, Canada / University of Toronto. Department of Medicine. Toronto, Canada / University Health Network. Division of Infectious Diseases. Toronto, Canada. | pt_BR |
| Affilliation | University of Toronto. Dalla Lana School of Public Health. Toronto, Canada / Toronto General Research Institute. Toronto, Canada. | pt_BR |
| Affilliation | University Health Network. Biostatistics Research Unit. Toronto, Canada. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Centro de Referência e Treinamento em DST/AIDS-SP. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Fundación Huesped. Buenos Aires, Argentina. | pt_BR |
| Affilliation | Fundación Huesped. Buenos Aires, Argentina. | pt_BR |
| Affilliation | Chelsea and Westminster Hospital. London, UK. | pt_BR |
| Affilliation | Brighton & Sussex University Hospital NHS Trust. Brighton, UK. | pt_BR |
| Affilliation | Guy's & St. Thomas' NHS Foundation Trust. London, UK. | pt_BR |
| Affilliation | CIHR Canadian HIV Trials Network. Vancouver, Canada. | pt_BR |
| Affilliation | University of Toronto. Department of Medicine. Toronto, Canada / University Health Network. Division of Infectious Diseases. Toronto, Canada / Toronto General Research Institute. Toronto, Canada / CIHR Canadian HIV Trials Network. Vancouver, Canada. | pt_BR |
| Subject | HIV | en |
| Subject | Valaciclovir | en |
| Subject | CD4 counts | en |
| Embargo date | 2038-08-30 | |
