NCT00383734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

December 22, 2011

Status Verified

December 1, 2011

Enrollment Period

1.8 years

First QC Date

October 2, 2006

Last Update Submit

December 21, 2011

Conditions

HIV-Associated Lipodystrophy Syndrome

Keywords

HIV-Associated Lipodystrophy Syndromepolylactic acidpolyacrylamide gels

Outcome Measures

Primary Outcomes (1)

  • - patient's subjective self-perception of improvement of facial lipoatrophy as assessed by a VAS

    week 48

Secondary Outcomes (1)

  • 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

    week 0, week 48 and week 96

Study Arms (2)

1

EXPERIMENTAL

newfill

Device: Newfill

2

EXPERIMENTAL

Eutrophill

Device: Eutrophill

Interventions

NewfillDEVICE

1 to 7 injections of drug

1
EutrophillDEVICE

1 to 7 injections of drug

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint-Louis Service des Maladies Infectieuses

Paris, 75010, France

Location

Related Publications (1)

  • 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.

    PMID: 23432777DERIVED

MeSH Terms

Conditions

HIV-Associated Lipodystrophy Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesLipodystrophySkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Matthieu Lafaurie, MD

    Hopital Saint Louis AP-HP

    PRINCIPAL INVESTIGATOR

  • Raphael Porcher, MD

    Hôpital Saint-Louis AP-HP

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2006

First Posted

October 3, 2006

Study Start

December 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2010

Last Updated

December 22, 2011

Record last verified: 2011-12

Locations

FR(1)