Status:
COMPLETED
Safety and Efficacy of Intradermal Injections of Newfill Versus Eutrophill in the Treatment of Facial Lipoatrophy in HIV-infected Patients ANRS 132 SMILE
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Procitech
Sanofi
Conditions:
HIV-Associated Lipodystrophy Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00383734
Start Date
December 1 2006
End Date
September 1 2010
Last Update
December 22 2011
Active Locations (1)
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1
Hôpital Saint-Louis Service des Maladies Infectieuses
Paris, France, 75010