HIV Infection Clinical Trial
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
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;
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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