Safety and Efficacy of Intradermal Injections of Newfill Versus Eutrophill in the Treatment of Facial Lipoatrophy in HIV-infected Patients ANRS 132 SMILE
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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 |
- - patient's subjective self-perception of improvement of facial lipoatrophy as assessed by a VAS [ Time Frame: week 48 ] [ 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 [ 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 |
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| France | |
| Hôpital Saint-Louis Service des Maladies Infectieuses | |
| Paris, France, 75010 | |
| 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
| 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:
|
Lipodystrophy HIV-Associated Lipodystrophy Syndrome 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 March 07, 2013
