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

NCT ID: NCT00383734

Last Updated: 2011-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2010-09-30

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.

Conditions

HIV-Associated Lipodystrophy Syndrome

Keywords

HIV-Associated Lipodystrophy Syndrome; polylactic acid; polyacrylamide gels

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

newfill

Group Type: EXPERIMENTAL

Newfill

Intervention Type: DEVICE

1 to 7 injections of drug

2

Eutrophill

Group Type: EXPERIMENTAL

Eutrophill

Intervention Type: DEVICE

1 to 7 injections of drug

Interventions

Newfill

1 to 7 injections of drug

Intervention Type: DEVICE

Eutrophill

1 to 7 injections of drug

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Procitech

UNKNOWN

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthieu Lafaurie, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Saint Louis AP-HP

Raphael Porcher, MD

Role: STUDY_CHAIR

Hôpital Saint-Louis AP-HP

Locations

Hôpital Saint-Louis Service des Maladies Infectieuses

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 23432777 (View on PubMed)

Other Identifiers

ANRS 132

Identifier Type: -

Identifier Source: org_study_id