Facial Lipoatrophy Trial: Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial Lipoatrophy

This study has been terminated.
(no change in primary endpoint at week 48)
Sponsor:
Collaborators:
The University of New South Wales
Abbott
Bristol-Myers Squibb
Gilead Sciences
GlaxoSmithKline
Merck Sharp & Dohme Corp.
Hoffmann-La Roche
AIDS Council of New South Wales
Information provided by:
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00126308
First received: August 1, 2005
Last updated: March 31, 2009
Last verified: March 2009
  Purpose

This is a multi-centre, open-label, 96 week study to evaluate the safety, tolerability and extent and duration of improvement in HIV-1 infected subjects with antiretroviral induced facial lipoatrophy, randomised in a 1:1 ratio to receive immediate or deferred deep subcutaneous injections of poly-L-lactic acid (PLA). Subjects will receive 4 treatments of PLA approximately every 2nd week, either at trial entry or following a delay period of 24 weeks.


Condition Intervention Phase
HIV-Associated Lipodystrophy
HIV Infections
Device: poly-L-lactic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Centre, Open-Label, Randomised Study to Assess the Efficacy, Durability and Safety of Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial Lipoatrophy (FLASH)

Resource links provided by NLM:


Further study details as provided by Kirby Institute:

Primary Outcome Measures:
  • The primary endpoint at 24 weeks will be change from baseline in facial soft tissue volume as measured by spiral computed tomography (CT). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline at week 96 in facial soft tissue volume as measured by spiral CT scan [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change from baseline at weeks 24 and 96 in physician and patient assessment of facial lipoatrophy severity [ Time Frame: 24 and 96 weeks ] [ Designated as safety issue: No ]
  • Change from baseline at weeks 24 and 96 in peripheral fat as assessed by dual-energy X-ray absorptiometry (DEXA) [ Time Frame: 24 and 96 weeks ] [ Designated as safety issue: No ]
  • Change from baseline at weeks 24 and 96 in quality of life [ Time Frame: 24 and 96 weeks ] [ Designated as safety issue: No ]
  • Change from baseline at weeks 24 and 96 in antiretroviral therapy (ART) adherence and plasma HIV-RNA [ Time Frame: 24 and 96 weeks ] [ Designated as safety issue: No ]
  • All serious, grade 3 or 4 clinical adverse events and any adverse event leading to change/s in ART or discontinuation of PLA [ Time Frame: 24 and 96 weeks ] [ Designated as safety issue: Yes ]
  • All serious, grade 3 or 4 clinical adverse events (AEs) and any event leading to change/s in ART reported to week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • All AEs attributable to study treatment reported to week 96 [ Time Frame: week 96 ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: November 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate
poly-L-lactic acid injections
Device: poly-L-lactic acid
immediate injections poly-L-lactic acid (4 bilateral treatments - 8 vials)
Other Name: Sculptra
Active Comparator: Delayed
poly-L-lactic acid injections
Device: poly-L-lactic acid
delayed (24 weeks) poly-L-lactic acid injections (4 bilateral treatment - 8 vials)
Other Name: Sculptra

Detailed Description:

HIV lipodystrophy can be distressing and result in suboptimal antiretroviral (ART) adherence. Physical changes may stigmatise subjects while the negative psychological and social impact has become a major concern. To date, as there is no proven therapy for lipoatrophy, cosmetic interventions for facial lipoatrophy are being studied. Poly-L-lactic acid (PLA) has been shown to be both safe and effective when administered by injection to facial areas.

Study aims are:

  1. to evaluate the extent and duration of improvement in HIV facial lipoatrophy of PLA injections;
  2. to evaluate the impact of PLA injections on quality of life and ART adherence in subjects with HIV facial lipoatrophy;
  3. to evaluate the safety and tolerability of polylactic acid.

100 HIV-infected ART-experienced subjects with facial lipoatrophy will be randomised in a 1:1 ratio at study entry to receive either immediate or deferred treatment (delayed 24 weeks) treatment with PLA. Randomisation will be stratified by age, severity of facial lipoatrophy, current ART (PI or non-PI containing and thymidine- or non-thymidine-containing) and surgeon.

The study has clinical end points monitoring CD4 cell counts, viral loads and adverse events. The study also has psychosocial end points monitoring quality of life.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 years or more with laboratory evidence of HIV-1 infection
  • Received combination antiretroviral therapy (minimum of 2 agents)
  • Antiretroviral regimen should be stable for at least 12 weeks prior to entry with no changes planned during the first 48 weeks. For subjects not on antiretroviral therapy at entry there should be no intent to commence therapy in first 24 weeks.
  • Moderate or severe facial lipoatrophy and lipodystrophy at one or more other sites
  • Provide written, informed consent.

Exclusion Criteria:

  • Active AIDS-defining illness including active HIV wasting
  • Active herpes labialis or any acute or currently present chronic skin disease (infection/inflammation) on/near area to be treated
  • Currently on anticoagulants or any coagulopathy that would preclude safe deep subcutaneous injections
  • Women: pregnant, breastfeeding or have positive pregnancy test or not willing to use adequate contraception if of child-bearing potential
  • Concomitant therapy with anabolic steroids (except testosterone replacement), corticosteroids at greater than replacement doses, growth hormone or any currently available or experimental agent to improve appetite or weight
  • Testosterone replacement for less than 6 months or at greater than replacement doses
  • Subjects who have discontinued any prohibited concomitant agent/s must cease this therapy at least 30 days prior to screening.
  • Prior use of any facial dermal filling/tissue expansion agent/s
  • Any condition which may interfere with ability to comply with study requirements.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126308

Locations
Australia, New South Wales
Dr Doong's Surgery
Burwood, New South Wales, Australia, 2134
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Holdsworth House General Practice
Sydney, New South Wales, Australia, 2010
Taylor Square Private Clinic
Sydney, New South Wales, Australia, 2010
AIDS Research Initiative
Sydney, New South Wales, Australia, 2010
407 Doctors
Sydney, New South Wales, Australia, 2010
Albion Street Clinic
Sydney, New South Wales, Australia, 2010
St. Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Liverpool Health Service
Sydney, New South Wales, Australia, 2170
Waratah Clinic, St. George Hospital
Sydney, New South Wales, Australia, 2217
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Gladstone Road Medical Centre
Brisbane, Queensland, Australia, 4101
Queensland Health - AIDS Medical Unit
Brisbane, Queensland, Australia, 4002
Gold Coast Sexual Health Clinic
Gold Coast, Queensland, Australia, 4220
Clinic 87
Nambour, Queensland, Australia, 4560
Australia, South Australia
The Care and Prevention Programme - Adelaide University
Adelaide, South Australia, Australia, 5000
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6001
Sponsors and Collaborators
Kirby Institute
The University of New South Wales
Abbott
Bristol-Myers Squibb
Gilead Sciences
GlaxoSmithKline
Merck Sharp & Dohme Corp.
Hoffmann-La Roche
AIDS Council of New South Wales
Investigators
Principal Investigator: Andrew Carr, A/Prof Immunology and Infectious Disease Unit, St. Vincent's Hospital, Sydney
  More Information

Additional Information:
No publications provided

Responsible Party: The National Centre in HIV Epidemiology and Clinical Research
ClinicalTrials.gov Identifier: NCT00126308     History of Changes
Other Study ID Numbers: V1-0 4-05, ACTR012605000132640
Study First Received: August 1, 2005
Last Updated: March 31, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Kirby Institute:
HIV
Lipodystrophy
Intervention
Poly-L-lactic acid
HIV facial lipoatrophy
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV-Associated Lipodystrophy Syndrome
Lipodystrophy
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lipid Metabolism Disorders
Metabolic Diseases
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases
Skin Diseases, Metabolic
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014