Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT00931268
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00931268
Study Brief:
Protocol Section:
NCT00931268