Polyacrylamide Hydrogel Injection in HIV-related Lipoatrophy (LIPOPHILL)
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ClinicalTrials.gov Identifier: NCT01077765 |
Recruitment Status :
Completed
First Posted : March 1, 2010
Last Update Posted : March 1, 2010
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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 |
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 (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 |
Arm | Intervention/treatment |
---|---|
Experimental: treatment
treatment
|
Device: Eutrophill
Polyacrylamide Hydrogel |
- Cutaneous tissue thickness of the cheeks assessed by facial ultrasonography [ Time Frame: 12 months ]
- 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 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077765
France | |
Hopital europeen Georges Pompidou | |
Paris, France, 75015 |
Principal Investigator: | Christophe Piketty | Assistance Publique Hôpitaux de Paris-HEGP |
Responsible Party: | Mathieu Quintin, Departement clinical research of the developement |
ClinicalTrials.gov Identifier: | NCT01077765 |
Other Study ID Numbers: |
P040601 |
First Posted: | March 1, 2010 Key Record Dates |
Last Update Posted: | March 1, 2010 |
Last Verified: | January 2010 |
HIV-associated Lipodystrophy Polyacrylamide hydrogel |
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 |