Safety and Efficacy of Intradermal Injections of Newfill Versus Eutrophill in the Treatment of Facial Lipoatrophy in HIV-infected Patients ANRS 132 SMILE

The aim of the study is to compare the efficacy and safety of Eutrophill (polyacrylamid gel), a resorbable filler compound versus Newfill( polylactic acid) in a comparative, randomised, multicenter trial and patient-blinded study, in the treatment of facial lipoatrophy in HIV-infected patients, one year after the first injection (week 48). The efficacy will be assessed by measuring the median self-perception index of the patients with a visual analogue scale (VAS index).The study will compare between treatments, at week 48, week 72 and week 96 versus baseline :the median increase of the VAS index, the rate of treatment failure, the scores of 2 patients-questionnaires (a-NBC and MOS-HIV),the ordering of digital photographs,the median increase of the facial dermal thickness of the cheek and the dermal skin fold as assessed by a Skinfold Caliper.

The study will compare at week 48 and week 96 versus baseline:

the median increase of dermal thickness as assessed by CT scan of the face. Safety will be assessed by the frequency and nature of immediate and delayed side effects.

Inclusion criteria

• 18 years of age and older
• confirmed laboratory diagnosis of HIV infection
• facial lipoatrophy
• stable antiretroviral treatment or no treatment for at least 3 months
• written informed consent

Exclusion criteria

• history of surgical or cosmetic intervention for facial lipoatrophy
• no history of antiretroviral therapy
• current opportunistic infection
• currently stavudine containing antiretroviral regimen
• CD4 cell count under 200per µL, plasma HIV RNA above 10000 copies per mL under antiretroviral therapy
• platelets under 50000 per µL and or abnormal coagulation tests
• pregnancy
• major or concomitant illness