Studies

PENTA 11

December 31, 2014

Project no.: HIV-NAT 066

PENTA 11 was an open, multicentre randomised phase II trial coordinated by PENTA to determine whether HIV-positive children are disadvantaged clinically, immunologically or virologically by CD4-driven planned treatment interruptions.

This pilot study enrolled chronically infected children aged 2 – 15 years of age with suppressed HIV viral load and CD4% ≥ 30% (ages 2-6) or CD4% ≥ 25% and CD4 ≥ 500 cells/mm3 (ages 7 and over). After two years of follow-up post-trial, no adverse clinical, immunological or virological consequences of planned treatment interuptions were observed. The study was supported by PENTA, Great Ormond Street Children’s Charity, and the European Union’s 7th Framework Programme.

Publication:

  1. Response to planned treatment interruptions in HIV infection varies across childhood. AIDS (London, England).  2010 Jan 16;24(2):231-41.
  2. Adherence to Antiretroviral Therapy and Acceptability of Planned Treatment Interruptions in HIV-Infected Children. AIDS and Behavior 2012 May 15.
  3. Outcomes after reinitiating antiretroviral therapy in children randomized to planned treatment interruptions in the PENTA 11 Study. AIDS. 2013 Feb 20;27(4):579-89.AIDS. 2013 Feb 20;27(4):579-89.