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
  Purpose

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.


Condition Intervention Phase
HIV-Associated Lipodystrophy Syndrome
Device: Newfill
Device: Eutrophill
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • - patient's subjective self-perception of improvement of facial lipoatrophy as assessed by a VAS [ Time Frame: week 48 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 148
Study Start Date: December 2006
Study Completion Date: September 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
newfill
Device: Newfill
1 to 7 injections of drug
Experimental: 2
Eutrophill
Device: Eutrophill
1 to 7 injections of drug

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383734

Locations
France
Hôpital Saint-Louis Service des Maladies Infectieuses
Paris, France, 75010
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Procitech
Sanofi
Investigators
Principal Investigator: Matthieu Lafaurie, MD Hopital Saint Louis AP-HP
Study Chair: Raphael Porcher, MD Hôpital Saint-Louis AP-HP
  More Information

No publications provided by French National Agency for Research on AIDS and Viral Hepatitis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00383734     History of Changes
Other Study ID Numbers: ANRS 132
Study First Received: October 2, 2006
Last Updated: December 21, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV-Associated Lipodystrophy Syndrome
polylactic acid
polyacrylamide gels

Additional relevant MeSH terms:
Syndrome
Lipodystrophy
HIV-Associated Lipodystrophy Syndrome
Disease
Pathologic Processes
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on October 01, 2014