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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Completed

Phase 3

Conditions

HIV-Associated Lipodystrophy Syndrome

Treatments

Device: Eutrophill

Device: Newfill

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00383734

ANRS 132

Details and patient eligibility

About

Treatment of facial lipoatrophy with dermal injections polylactic acid (Newfill TM) is a safe procedure and has been now widely used with a good efficacy. However, this therapy is not effective in all treated patients and the benefit of the injections may decrease with time necessitating re-injections several months after the first sets of injections. In this study we would like to compare the efficacy and safety of Eutrophill(polyacrylamid gel), a resorbable filler compound versus Newfill in a comparative, randomised, multicenter trial. Primary endpoint will be the self-perception by the patient with a visual analogue scale (VAS index). Secondary endpoints are a quality of life questionnaire (MOS-HIV), the a-NBC questionnaire (perception by the patient and by the doctor of the severity of the lipoatrophy), the measure of the dermal thickness and cheek skin fold as assessed by the Skinfold Caliper, the ordering of digital photographs and the evaluation of the dermal thickness by CT scan.

Full description

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.

Enrollment

148 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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