Lack of benefit of 3-month intensification with enfuvirtide plus optimized background regimen (OBR) versus OBR alone in patients with multiple therapeutic failures: the INNOVE study.

The objective of the present study was to evaluate the virological efficacy of a 3-month short-course intensification with enfuvirtide (ENF) associated with an optimized background regimen (OBR) in treatment-experienced patients infected with HIV-1 with multiple therapeutic failures. This was a prospective, randomized, open-label multicenter trial including patients infected with HIV-1 and harboring a multi-resistant virus that was still susceptible to at least 2 active compounds. Patients were randomized (1:1) to receive OBR + ENF or OBR alone. ENF was discontinued at Week 12. The primary endpoint was the proportion of patients with plasma viral load <50 copies/ml at Week 24. Fifteen patients were randomized into the OBR group and 14 into the OBR + ENF group with a median viral load of 4.1 log(10)  copies/ml and a median CD4+ cell count of 346 cells/mm(3) . The primary endpoint was achieved in 93% (14/15) and 79% (11/14) of patients, respectively. Eighty-seven percent (13/15) of patients had a viral load <50 copies/ml as soon as Week 12 in the OBR group and 79% (11/14) in the OBR + ENF group. At Week 12, the median CD4+ cell count was 327 in the OBR and 437 in the OBR + ENF groups and at Week 24 they were comparable. Intensification with ENF had no significant impact on PBMCs HIV-DNA levels. A 3-month short-course intensified treatment with ENF did not improve Week-24 virological response in treatment-experienced patients infected with HIV-1 harboring resistant viruses that were still susceptible to two antiretroviral drugs.