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Clinical trial

Towards HIV Functional Cure (ULTRASTOP)

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Last updated:31st May 2013
During the ERAMUNE-01 and -02 studies, the HIV-DNA quantification in the PBMCs (Peripheral Blood Mononuclear Cells) showed showed that some patients had a very low or undetectable reservoir. Recent studies showed that a low reservoir is associated to a spontaneous virologic control in three specific categories of patients: - "Elite Controllers": these rare patients are able to spontaneously maintain an HIV-RNA viral load below 50 copies/mL and elevated CD4 counts without any treatment. These patients belong to the B27/B57 haplotypes associated to a reduced risk of HIV contamination but these haplotypes are very rare in the global population (0,3 %) - "Visconti" patients: early-treated patients, during the primo-infection stage. After 3 to 5 years of treatment, these patients are able to maintain an undetectable HIV-RNA viral load. - "Salto" patients: these patients are treated a bit later compared to the Visconti cohort, when their CD4 count was above 350 cells/mm3 and their HIV-RNA viral load below 50 000 copies/mL. The follow-up of these patients showed the same capacity of control of the HIV infection for at least 2 years following treatment interruption. Taking into account these 3 categories of patients which common characteristics is a low reservoir, our objective is to answer the 2 following questions: - Is it possible to discontinue the treatment in chronically-infected patients with a "normal" immune system and with an undetectable HIV-DNA reservoir? - Is a low viral reservoir predictive of a treatment-free remission of the HIV infection in chronically-infected patients? The main objective of the proof-of-concept ERAMUNE-03 trial is to evaluate the proportion of patients in success (i.e. able to maintain a virologic and an immunologic control of the infection) after treatment discontinuation, failure is defined as: - An HIV-RNA viral load > 400 copies/mL on 2 consecutive tests starting from Week 4 - Or CD4 count < 400 cells/mm3 on 2 consecutive measures starting from Week 4 - Or the onset of an AIDS-related event
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Study start date 2013-05-31

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