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Purpose: To evaluate polyalkylamide gel (PAIG) use in treating HIV-associated facial lipoatrophy (FLA) 4 years after its injection in an open-label, randomized controlled trial (RCT). Methods: Five patients were treated with PAIG in a pilot study, and 31 patients were subsequently enrolled in the RCT of immediate or delayed (12 weeks later) PAIG injections. Endpoints included proportion of participants with complications; changes in FLA severity score (FLSS); and quality of life (QoL), depression, anxiety, and satisfaction scores. Infections were classified as 'confirmed' if purulent material was extracted and/or an organism cultured. Infections were classified as 'possible' if only clinical signs were present without purulent discharge or microbiologic confirmation. Results: Year 4 results were available for 5 pilot and 27 full-scale study participants. Delayed complications included 5 confirmed infections (15.6%), 3 possible infections (9.4%), nodules (25%), and bleeding (3%). No significant changes were observed between years 2 to 4 in patient-graded FLSS, QoL, depression, and anxiety scores. Whereas 94% of participants were satisfied with their overall treatment, only 69% were satisfied with PAIG treatment specifically. Conclusion: Even though PAIG treatment was associated with delayed complications including high rates of infection and nodules, most patients were satisfied with the treatment. [ABSTRACT FROM AUTHOR]

The development of new drugs to counter human immunodeficiency virus (HIV) infection has led to an increase in lipodystrophic syndrome among HIV-infected individuals receiving combination therapy. Bio-Alcamid TM is a recently developed polymeric substance that can be implanted to compensate for adipose effects. We have implanted this substance in 73 patients with up to three years' follow-up. The aesthetic results were deemed excellent by both physicians and patients. No implant dislocation, implant migration, granuloma, allergic reaction or intolerance were recorded. [ABSTRACT FROM AUTHOR]