Facial Lipoatrophy Trial: Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial Lipoatrophy

• The primary endpoint at 24 weeks will be change from baseline in facial soft tissue volume as measured by spiral computed tomography (CT). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  

• Change from baseline at week 96 in facial soft tissue volume as measured by spiral CT scan [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  
• Change from baseline at weeks 24 and 96 in physician and patient assessment of facial lipoatrophy severity [ Time Frame: 24 and 96 weeks ] [ Designated as safety issue: No ]
  
• Change from baseline at weeks 24 and 96 in peripheral fat as assessed by dual-energy X-ray absorptiometry (DEXA) [ Time Frame: 24 and 96 weeks ] [ Designated as safety issue: No ]
  
• Change from baseline at weeks 24 and 96 in quality of life [ Time Frame: 24 and 96 weeks ] [ Designated as safety issue: No ]
  
• Change from baseline at weeks 24 and 96 in antiretroviral therapy (ART) adherence and plasma HIV-RNA [ Time Frame: 24 and 96 weeks ] [ Designated as safety issue: No ]
  
• All serious, grade 3 or 4 clinical adverse events and any adverse event leading to change/s in ART or discontinuation of PLA [ Time Frame: 24 and 96 weeks ] [ Designated as safety issue: Yes ]
  
• All serious, grade 3 or 4 clinical adverse events (AEs) and any event leading to change/s in ART reported to week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  
• All AEs attributable to study treatment reported to week 96 [ Time Frame: week 96 ] [ Designated as safety issue: Yes ]
  

HIV lipodystrophy can be distressing and result in suboptimal antiretroviral (ART) adherence. Physical changes may stigmatise subjects while the negative psychological and social impact has become a major concern. To date, as there is no proven therapy for lipoatrophy, cosmetic interventions for facial lipoatrophy are being studied. Poly-L-lactic acid (PLA) has been shown to be both safe and effective when administered by injection to facial areas.

Study aims are:

1. to evaluate the extent and duration of improvement in HIV facial lipoatrophy of PLA injections;
2. to evaluate the impact of PLA injections on quality of life and ART adherence in subjects with HIV facial lipoatrophy;
3. to evaluate the safety and tolerability of polylactic acid.

100 HIV-infected ART-experienced subjects with facial lipoatrophy will be randomised in a 1:1 ratio at study entry to receive either immediate or deferred treatment (delayed 24 weeks) treatment with PLA. Randomisation will be stratified by age, severity of facial lipoatrophy, current ART (PI or non-PI containing and thymidine- or non-thymidine-containing) and surgeon.

The study has clinical end points monitoring CD4 cell counts, viral loads and adverse events. The study also has psychosocial end points monitoring quality of life.