Polyacrylamide Hydrogel Injection in HIV-related Lipoatrophy

NCT ID: NCT01077765

Last Updated: 2010-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2009-09-30

Brief Summary

Combined antiretroviral therapy (cART) is associated with facial lipoatrophy, which is potentially stigmatizing for HIV-positive patients. Eutrophill is a 2.5% polyacrylamide hydrogel obtained by polymerization of acrylamide monomers with an official half-life of 5 years.

Preliminary encouraging results with the use of polyacrylamide hydrogel for reconstruction of facial lipoatrophy in HIV-infected patients have been previously reported.

The primary objective of the study was to evaluate the long-term efficacy and safety of subcutaneous facial injections of Eutrophill in HIV-infected patients with severe facial lipoatrophy as assessed by facial ultrasonography at screening , after 6, 12 and 24 months

Detailed Description

Combined antiretroviral therapy is associated with facial lipoatrophy, which is potentially stigmatizing for HIV-infected patients.

To date, polylactic acid implants (PLA) have been approved for the correction of facial lipoatrophy. The mechanism of action is the increase in new collagen synthesis as a reaction to the presence of the implant in the dermal area. But PLA may be associated with:subcutaneous micronodules and indurations and mid term relapse of lipoatrophy with the need to proceed to new PLA injections EUTROPHILL is a 2.5% polyacrylamide hydrogel with a claimed half-life of 5 years.The gel is relatively viscous and is injected subcutaneously. Following injection, the gel encapsulates. The mechanism of action is the increase in the volume of subcutaneous area by the inert implant

The aim of this multicentric, open-label, single-arm, pilot study was to evaluate the long-term efficacy and safety of intra-dermal facial injections of polyacrylamide hydrogel (EUTROPHILL) in HIV-infected patients with severe facial lipoatrophy. Patients received between 2 and 6 injections every 4 weeks, according to the aesthetic results.

The primary objective of the study was to evaluate the long-term efficacy of subcutaneous facial injections of EUTROPHILL in HIV-infected patients with severe facial lipoatrophy as assessed by facial ultrasonography at screening , after 6, 12 and 24 months

The secondary objectives of the study were:

to evaluate the clinical efficacy by facial photography at screening, after 6, 12 and 24 months; to evaluate Overall Treatment Satisfaction according to patients , close relatives and physicians ; to evaluate changes in quality of life (ABCD questionnaire) ABCD questionnaire is a specific questionnaire validated for HIV-infected patients suffering from lipodystrophy; to evaluate changes in patient's anxiety and depression (HADS questionnaire); to evaluate the safety of the infiltration techniques;

Conditions

HIV Infection; Antiretroviral Side Effects; Lipodystrophy Syndrome Related to HIV Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment

treatment

Group Type: EXPERIMENTAL

Eutrophill

Intervention Type: DEVICE

Polyacrylamide Hydrogel

Interventions

Eutrophill

Polyacrylamide Hydrogel

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• HIV-infected patients
• 18 years of age or older
• Severe facial lipoatrophy.
• Stable antiretroviral treatment at least 3 months prior to the inclusion
• CD4 cell count > 100 cells/mm3
• Written informed consent

Exclusion Criteria

• History of surgical or cosmetic intervention for facial lipoatrophy
• Ongoing opportunistic infection
• Any facial skin disease including Kaposi Sarcoma
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Departement clinical research of the developement

Principal Investigators

Christophe Piketty

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hôpitaux de Paris-HEGP

Locations

Hopital europeen Georges Pompidou

Paris, , France

Countries

France

Other Identifiers

P040601

Identifier Type: -

Identifier Source: org_study_id