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Safety, Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid

NCT00333684 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2012-06-05

No results posted yet for this study

Summary

Evaluate and record any changes in the Quality of Life and psychological state of the affected study group following treatment with Bio-Alcamid.

Evaluate the safety and efficacy of Bio-Alcamid for restoring the natural fullness and contours of the face affected by HIV drug-induced lipoatrophy. Pre-treatment classification and post treatment recording of changes will be performed by, both, the Principal Investigator and the Treatment Specialist and independently by a 'Blinded' Co-Investigator at post treatment Week 12.

Safety data for Bio-Alcamid will be collected throughout the duration of the study. Safety will be determined by the rates of procedure-related events and adverse experiences associated with the use of Bio-Alcamid.

Conditions

  • Human Immunodeficiency Virus
  • Facial Lipoatrophy

Interventions

DEVICE

BIO-ALCAMID SOFT TISSUE ENDOPROSTHESIS

prosthetic bioalcamid was injected- amounts determined by the plastic surgeon and depended individual needs

Sponsors & Collaborators

  • Pur Medical Corporation

    collaborator UNKNOWN

  • Canadian Immunodeficiency Research Collaborative

    lead OTHER

Principal Investigators

  • Mona Loutfy, MD, FRCP(C) · Canadian Immunodeficiency Research Collaborative

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2006-11-30
Completion
2010-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00333684 on ClinicalTrials.gov