NCT00126308

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

A Multi-Centre, Open-Label, Randomised Study to Assess the Efficacy, Durability and Safety of Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial Lipoatrophy (FLASH)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-centre, open-label, 96 week study to evaluate the safety, tolerability and extent and duration of improvement in HIV-1 infected subjects with antiretroviral induced facial lipoatrophy, randomised in a 1:1 ratio to receive immediate or deferred deep subcutaneous injections of poly-L-lactic acid (PLA). Subjects will receive 4 treatments of PLA approximately every 2nd week, either at trial entry or following a delay period of 24 weeks.

Detailed description

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.

Conditions

• HIV-Associated Lipodystrophy
• HIV Infections

Interventions

Type	Name	Description
DEVICE	poly-L-lactic acid	immediate injections poly-L-lactic acid (4 bilateral treatments - 8 vials)
DEVICE	poly-L-lactic acid	delayed (24 weeks) poly-L-lactic acid injections (4 bilateral treatment - 8 vials)

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2005-08-03
• Last updated: 2009-04-02

Locations

18 sites across 1 country: Australia