Clinical trial NCT00383734: Safety and Efficacy of Intradermal Injections of Newfill Versus Eutrophill in the Treatment of Facial Lipoatrophy in HIV-infected Patients ANRS 132 SMILE
Official title: Randomized, Comparative, Multicenter, Patient-blinded Trial of the Safety and Efficacy of Intradermal Injections of Polylactic Acid (Newfill TM) Versus Polyacrylamid Gel (Eutrophill) in the Treatment of Facial Lipoatrophy in HIV-infected Patients ANRS 132 SMILE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV-Associated Lipodystrophy Syndrome
Keywords: HIV-Associated Lipodystrophy Syndrome
polylactic acid
polyacrylamide gels
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
Collaborators: name: Procitech
name: Sanofi
First posted: 2006-10-03
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: - patient's subjective self-perception of improvement of facial lipoatrophy as assessed by a VAS
timeFrame: week 48
Secondary outcomes:
measure: quality of life questionnaire,NBC questionnaire, dermal thickness and cheek skin fold as assessed by the Skinfold Caliper, digital photographs, dermal thickness as assessed by CT scan
timeFrame: week 0, week 48 and week 96
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint-Louis Service des Maladies Infectieuses
Study officials:
affiliation: Hopital Saint Louis AP-HP
name: Matthieu Lafaurie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Saint-Louis AP-HP
name: Raphael Porcher, MD
role: STUDY_CHAIR
References:
citation: Lafaurie M, Dolivo M, Girard PM, May T, Bouchaud O, Carbonnel E, Madelaine I, Loze B, Porcher R, Molina JM; ANRS 132 SMILE study group. Polylactic acid vs. polyacrylamide hydrogel for treatment of facial lipoatrophy: a randomized controlled trial [Agence Nationale de Recherches sur le SIDA et les Hepatites Virales (ANRS) 132 SMILE]. HIV Med. 2013 Aug;14(7):410-20. doi: 10.1111/hiv.12021. Epub 2013 Feb 24.