Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane

Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Stabilized Hyaluronic Acid of Non-animal Origin (Macrolane); a Baseline-controlled Single-centre Study.

The study is being undertaken to establish the effectiveness and safety of Macrolane volume restoration factor 30 (VRF30) when used for treatment of HIV-infected subjects with buttocks lipoatrophy.

Inclusion Criteria:

• Have buttocks lipoatrophy and is unable to remain seated for more than 30 minutes due to pain.
• Have undergone HIV treatment for more than 2 years.
• Have RNA copies less than 50/ml.
• Have CD4 more than 200 cell/mm3.

Exclusion Criteria:

• Active infections.
• Active skin disease, inflammation or related conditions.
• Perineal pathology.
• Condition that may affect pain assessment.
• Skin with underlying fibrous tissue.
• BMI less than 19.
• Insufficient tissue cover in the area to be treated.
• Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 14 days prior to treatment, or a history of bleeding disorders.
• Permanent implant placed in the treatment area.
• Other injectable implant, liposuction or other surgical therapy in the treatment area.
• Presence or history of connective tissue diseases.
• Tumors or pre-malign tissue disorder near or on the area to be treated.
• Contraindications for MRI
• Previous hypersensitivity to hyaluronic acid, or to the local anesthetic or antibiotic used in the study.