HIV-Associated Lipodystrophy Syndrome
Conditions
Keywords
HIV-Associated Lipodystrophy Syndrome, polylactic acid, polyacrylamide gels
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.
Interventions
DEVICENewfill
1 to 7 injections of drug
DEVICEEutrophill
1 to 7 injections of drug
Sponsors
Procitech
Sanofi
French National Agency for Research on AIDS and Viral Hepatitis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - patient's subjective self-perception of improvement of facial lipoatrophy as assessed by a VAS | week 48 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed