Long-Term Supervised Treatment Interruption in HIV-Infected Patients

Long-Term Supervised Treatment Interruption in HIV-Infected Patients Who Started Antiretroviral Treatment With CD4 Over 350/mm3 and Plasma HIV RNA Below 50 000/mL ANRS 116 Trial SALTO

This trial is aimed at studying the safety of long term supervised treatment interruption in HIV infected patients with CD4 over 350/mm3 and plasma HIV RNA under 50 000/mL. Another aim of this study is to assess the immunological and virological factors associated with the duration of treatment interruption.

The limitations of the drugs used against HIV include their toxicity, their tolerability, their propensity to induce resistance when not taken with absolute regularity and their cost. Treatment interruption in patients receiving antiretroviral treatment in the setting of chronic infection are associated with viral rebound and rapid CD4 T cell decrease conducting to antiretroviral therapy restart. In patients with high CD4+ cell counts (patients receiving treatment of chronic infection with controlled viremia and patients who are receiving HAART now in whom treatment would not have been started based on current guidelines), we evaluated the safety of long term supervised treatment interruption. Another aim of this study was to assess the immunological and virological factors associated with the duration of treatment interruption (proviral HIV DNA at baseline and during follow-up, plasma HIV RNA at baseline and during follow-up, CD4 T cell and CD8 T cell HIV specific responses at baseline and after 12 months).

Predictive factors associated with the time of restart of antiretroviral therapy: Proviral HIV DNA at baseline and during follow-up

Inclusion Criteria: Males and non pregnant females 18 years of age and older Who have confirmed laboratory diagnosis of HIV infection Started on first line antiretroviral treatment with CD4 over 350/mm3 and plasma HIV RNA below 50 000/mL Ongoing Antiretroviral therapy at inclusion with CD4 over 450/mm3 and plasma HIV RNA below 5000/mL Exclusion Criteria: HBV-HIV co-infection receiving lamivudine therapy Ongoing immunotherapy including IL2, interferon or HIV specific vaccine Pregnancy or project of pregnancy

Weiss L, Piketty C, Assoumou L, Didier C, Caccavelli L, Donkova-Petrini V, Levy Y, Girard PM, Burgard M, Viard JP, Rouzioux C, Costagliola D; ANRS 116 SALTO study group. Relationship between regulatory T cells and immune activation in human immunodeficiency virus-infected patients interrupting antiretroviral therapy. PLoS One. 2010 Jul 21;5(7):e11659. doi: 10.1371/journal.pone.0011659.