Polyacrylamide Hydrogel Injection in HIV-related Lipoatrophy (LIPOPHILL)

• ClinicalTrials.gov Identifier: NCT01077765
• Recruitment Status: Completed
• First Posted: March 1, 2010
• Last Update Posted: March 1, 2010
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by: Assistance Publique - Hôpitaux de Paris

Study Description

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

Condition or disease	Intervention/treatment	Phase
HIV Infection; Antiretroviral Side Effects; Lipodystrophy Syndrome Related to HIV Infection	Device: Eutrophill	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: November 2005
• Actual Primary Completion Date: July 2008
• Actual Study Completion Date: September 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: treatment; treatment	Device: Eutrophill; Polyacrylamide Hydrogel

Outcome Measures

Primary Outcome Measures :

1. Cutaneous tissue thickness of the cheeks assessed by facial ultrasonography [ Time Frame: 12 months ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Hopital europeen Georges Pompidou

Paris, France, 75015

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Christophe Piketty; Assistance Publique Hôpitaux de Paris-HEGP

More Information

• Responsible Party: Mathieu Quintin, Departement clinical research of the developement
• ClinicalTrials.gov Identifier: NCT01077765
• Other Study ID Numbers: P040601
• First Posted: March 1, 2010
• Last Update Posted: March 1, 2010
• Last Verified: January 2010

Keywords provided by Assistance Publique - Hôpitaux de Paris:

HIV-associated Lipodystrophy; Polyacrylamide hydrogel

Additional relevant MeSH terms:

Infection; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Lipodystrophy; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Skin Diseases, Metabolic; Skin Diseases; Lipid Metabolism Disorders; Metabolic Diseases