Polyacrylamide Hydrogel Injection in HIV-related Lipoatrophy (LIPOPHILL)

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01077765
First received: February 26, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

February 26, 2010
February 26, 2010
November 2005
July 2008   (final data collection date for primary outcome measure)
Cutaneous tissue thickness of the cheeks assessed by facial ultrasonography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Polyacrylamide Hydrogel Injection in HIV-related Lipoatrophy
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

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;

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infection
  • Antiretroviral Side Effects
  • Lipodystrophy Syndrome Related to HIV Infection
Device: Eutrophill
Polyacrylamide Hydrogel
Experimental: treatment
treatment
Intervention: Device: Eutrophill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2009
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01077765
P040601
No
Mathieu Quintin, Departement clinical research of the developement
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Christophe Piketty Assistance Publique Hôpitaux de Paris-HEGP
Assistance Publique - Hôpitaux de Paris
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP