CompletedPhase 3

Polyacrylamide Hydrogel Injection in HIV-related Lipoatrophy

France100 participantsStarted 2005-11

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Cutaneous tissue thickness of the cheeks assessed by facial ultrasonography

Timeframe: 12 months

Trial details

NCT IDNCT01077765

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-07

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