Four-year follow-up of polyalkylimide gel use for the treatment of HIV-associated lipoatrophy.
HIV Clin Trials
; 12(6): 323-32, 2011.
Article
en En
| MEDLINE
| ID: mdl-22189151
ABSTRACT
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.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Resinas Acrílicas
/
Síndrome de Lipodistrofia Asociada a VIH
Tipo de estudio:
Clinical_trials
/
Risk_factors_studies
Límite:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Año:
2011
Tipo del documento:
Article