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

This study has been completed.
Sponsor:
Collaborators:
Procitech
Sanofi
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00383734
First received: October 2, 2006
Last updated: December 21, 2011
Last verified: December 2011

October 2, 2006
December 21, 2011
December 2006
September 2008   (final data collection date for primary outcome measure)
- patient's subjective self-perception of improvement of facial lipoatrophy as assessed by a VAS [ Time Frame: week 48 ] [ Designated as safety issue: Yes ]
- patient’s subjective self-perception of improvement of facial lipoatrophy as assessed by a VAS at week 48
Complete list of historical versions of study NCT00383734 on ClinicalTrials.gov Archive Site
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 [ Time Frame: week 0, week 48 and week 96 ] [ Designated as safety issue: Yes ]
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
Not Provided
Not Provided
 
Safety and Efficacy of Intradermal Injections of Newfill Versus Eutrophill in the Treatment of Facial Lipoatrophy in HIV-infected Patients ANRS 132 SMILE
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
HIV-Associated Lipodystrophy Syndrome
  • Device: Newfill
    1 to 7 injections of drug
  • Device: Eutrophill
    1 to 7 injections of drug
  • Experimental: 1
    newfill
    Intervention: Device: Newfill
  • Experimental: 2
    Eutrophill
    Intervention: Device: Eutrophill
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 Hépatites Virales (ANRS) 132 SMILE]. HIV Med. 2013 Aug;14(7):410-20. doi: 10.1111/hiv.12021. Epub 2013 Feb 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
148
September 2010
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00383734
ANRS 132
Yes
French National Agency for Research on AIDS and Viral Hepatitis
French National Agency for Research on AIDS and Viral Hepatitis
  • Procitech
  • Sanofi
Principal Investigator: Matthieu Lafaurie, MD Hopital Saint Louis AP-HP
Study Chair: Raphael Porcher, MD Hôpital Saint-Louis AP-HP
French National Agency for Research on AIDS and Viral Hepatitis
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP