Polyacrylamide Hydrogel Injection in HIV-related Lipoatrophy (LIPOPHILL)

Open Label, Multicenter, Single Arm Trial of the Safety and Efficacy of Polyacrylamide Hydrogel Injection in the Management of Human Immunodeficiency Virus-Related Facial Lipoatrophy : THE LIPOPHILL TRIAL

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

Study Overview

• Status: Completed
• Conditions: HIV Infection; Antiretroviral Side Effects; Lipodystrophy Syndrome Related to HIV Infection
• Intervention / Treatment: Device: Eutrophill

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;

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hopital Europeen Georges Pompidou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: treatment	Device: Eutrophill; Polyacrylamide Hydrogel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cutaneous tissue thickness of the cheeks assessed by facial ultrasonography	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Facial photography at screening,Overall Treatment Satisfaction according to patients close relatives and physicians,Changes in quality of life (ABCD questionnaire) after Changes.	6, 12 and 24 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Christophe Piketty, Assistance Publique Hôpitaux de Paris-HEGP

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (ACTUAL): July 1, 2008
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: February 26, 2010
• First Submitted That Met QC Criteria: February 26, 2010
• First Posted (ESTIMATE): March 1, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 1, 2010
• Last Update Submitted That Met QC Criteria: February 26, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Polyacrylamide hydrogel; HIV-associated Lipodystrophy
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Skin Diseases; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Lipid Metabolism Disorders; Slow Virus Diseases; Skin Diseases, Metabolic; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; Lipodystrophy
• Other Study ID Numbers: P040601