Polyacrylamide Hydrogel Injection in HIV-related Lipoatrophy

NCT01077765 | Completed Phase 3

• 1 other identifier: P040601
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

HIV Infection; Antiretroviral Side Effects; Lipodystrophy Syndrome Related to HIV Infection

Keywords

HIV-associated Lipodystrophy; Polyacrylamide hydrogel

Outcome Measures

Primary Outcomes (1)

• Cutaneous tissue thickness of the cheeks assessed by facial ultrasonography

  12 months

Secondary Outcomes (1)

• Facial photography at screening,Overall Treatment Satisfaction according to patients close relatives and physicians,Changes in quality of life (ABCD questionnaire) after Changes.

  6, 12 and 24 months

Study Arms (1)

treatment

EXPERIMENTAL

treatment

Device: Eutrophill

Interventions

Eutrophill DEVICE

Polyacrylamide Hydrogel

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected patients
• years of age or older
• Severe facial lipoatrophy.
• CD4 cell count \> 100 cells/mm3
• Written informed consent

You may not qualify if:

• History of surgical or cosmetic intervention for facial lipoatrophy
• Ongoing opportunistic infection
• Any facial skin disease including Kaposi Sarcoma
• Pregnancy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital europeen Georges Pompidou

Paris, 75015, France

Location

MeSH Terms

Conditions

HIV Infections; HIV-Associated Lipodystrophy Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Lipodystrophy; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Christophe Piketty

  Assistance Publique Hôpitaux de Paris-HEGP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 1, 2010
• Study Start: November 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2009
• Last Updated: March 1, 2010

Record last verified: 2010-01

Locations

FR (1)