Background:  In severely immunosuppressed HIV infected patients, a delayed immunological response after initiation of HAART is associated with increased morbidity and mortality. We studied whether addition of enfuvirtide (ENF) to a background HAART would improve the CD4 cell count response at Wk 24.

Methods:  ANRS130 is a multicenter, open-label, randomised study, conducted in naive HIV infected patients either asymptomatic with CD4 <100/mm³ or with past or present history of stage B or C event and CD4 <200/mm³. All patients received a background regimen of tenofovir-emtricitabine, in combination with lopinavir/ritonavir (LPV/r) or efavirenz (EFV), and were randomised to receive ENF during 24 wks (ENF arm) or not (standard arm). Randomization was stratified on clinical stage (C or not C) and background antiretroviral regimen (LPV/r or EFV). The primary end-point was the proportion of patients achieving a CD4 cell count >200/mm³ at Wk 24 (intent to treat analysis).

Results:  We randomized 194 patients with the following characteristics: 72% stage C, 78% male, median age 43 yrs, median baseline CD4 count 30/mm³ and median HIV RNA 5.4 log₁₀ copies/mL. Median time between HIV diagnosis and baseline was 1.4 month. The background regimen included LPV/r in 80% of patients. One subject was lost to follow up and 8 discontinued the study (5 just after randomization and 3 after Wk 12). In 10 patients, ENF was permanently interrupted for poor convenience or local discomfort. Results were as follows:

Conclusions: The addition of enfuvirtide to a standard HAART is associated with a more rapid virological response but does not improve immunological outcome in naive HIV infected patients with severe immunosuppression.