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

NCT00333684 | Completed Phase 2

• 1 other identifier: LA-BA-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• To evaluate Quality of Life using the slightly modified Dermatology Quality Life Survey and the MOS-HIV Survey.

  To evaluate Quality of Life using the slightly modified Dermatology Quality Life Survey and the MOS-HIV Survey.

  96 weeks

Secondary Outcomes (1)

• Evaluate the safety and efficacy of Bioalcamid for restoring the natural fullness and contours of the face affected by HIV drug-induced lipoatrophy.

  96 weeks

Study Arms (2)

receive bioalcamid at baseline

ACTIVE COMPARATOR

half subjects received bioalcamid at baseline

Device: BIO-ALCAMID SOFT TISSUE ENDOPROSTHESIS

Receive bioalcamid at 24 weeks

ACTIVE COMPARATOR

other half of subjets received bioalcamid at 24 weeks

Device: BIO-ALCAMID SOFT TISSUE ENDOPROSTHESIS

Interventions

BIO-ALCAMID SOFT TISSUE ENDOPROSTHESIS DEVICE

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

Receive bioalcamid at 24 weeks; receive bioalcamid at baseline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Have moderate to severe levels of facial lipoatrophy determined by the three investigstors
• If female of child-bearing potential (not menopausal for at least 1 year nor surgically sterile), have a negative urine pregnancy test prior to any study treatments and be willing to use oral contraception or another medically acceptable form of contraception for the duration of the study
• Be able to understand and comply with the requirements of this study
• Be willing and able to provide written Informed Consent prior to any study-related procedures being performed
• Agree to refrain from seeking other treatment for lipoatrophy in the facial area while participating in this study

You may not qualify if:

• Are pregnant, lactating, or trying to become pregnant
• Had prior therapy (e.g., other permanent or biodegradable injectable fillers or surgical correction such as a face-lift, etc.) within 9 months prior to entry into the study or are planning to undergo such therapy during the study
• Have any active inflammation, infection, or unhealed wound of the face
• Have any contraindicated condition described in the package insert for the product to be administered.
• Have a history of anaphylaxis or multiple severe allergies.
• Have planned relocation during the study, which would make follow-up visits impossible during the course of the study
• Used aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to initial or touch-up treatment or are taking concomitant anticoagulant therapy, anti-platelet therapy, or have a history of bleeding disorders
• Used over-the-counter wrinkle products (e.g., alpha-hydroxy acids) or prescription treatments (e.g., Renova, Retin-A, microdermabrasion, chemical peels) in the facial area within 4 weeks prior to study start. In addition, participants will be restricted from using over-the-counter wrinkle products or prescription treatments to the facial area for the duration of the study.
• Have received any investigational product within 30 days prior to study enrollment or are planning to receive other investigational products during the study

Sponsors & Collaborators

• Canadian Immunodeficiency Research Collaborative: lead
• Pur Medical Corporation: collaborator

Study Sites (1)

Maple Leaf Medical Clinic

Toronto, Ontario, M5B 1L6, Canada

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mona Loutfy, MD, FRCP(C)

  Canadian Immunodeficiency Research Collaborative

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2006
• First Posted: June 6, 2006
• Study Start: December 1, 2004
• Primary Completion: November 1, 2006
• Study Completion: May 1, 2010
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

CA (1)