Polyacrylamide Hydrogel Injection in HIV-related Lipoatrophy (LIPOPHILL)
Primary Purpose
HIV Infection, Antiretroviral Side Effects, Lipodystrophy Syndrome Related to HIV Infection
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Eutrophill
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring HIV-associated Lipodystrophy, Polyacrylamide hydrogel
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
Sites / Locations
- Hopital europeen Georges Pompidou
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment
Arm Description
treatment
Outcomes
Primary Outcome Measures
Cutaneous tissue thickness of the cheeks assessed by facial ultrasonography
Secondary Outcome Measures
Facial photography at screening,Overall Treatment Satisfaction according to patients close relatives and physicians,Changes in quality of life (ABCD questionnaire) after Changes.
Full Information
NCT ID
NCT01077765
First Posted
February 26, 2010
Last Updated
February 26, 2010
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01077765
Brief Title
Polyacrylamide Hydrogel Injection in HIV-related Lipoatrophy
Acronym
LIPOPHILL
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 Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. 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
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;
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Antiretroviral Side Effects, Lipodystrophy Syndrome Related to HIV Infection
Keywords
HIV-associated Lipodystrophy, Polyacrylamide hydrogel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
treatment
Intervention Type
Device
Intervention Name(s)
Eutrophill
Intervention Description
Polyacrylamide Hydrogel
Primary Outcome Measure Information:
Title
Cutaneous tissue thickness of the cheeks assessed by facial ultrasonography
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Piketty
Organizational Affiliation
Assistance Publique Hôpitaux de Paris-HEGP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Learn more about this trial
Polyacrylamide Hydrogel Injection in HIV-related Lipoatrophy
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