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

Primary Purpose

HIV-Associated Lipodystrophy, HIV Infections

Status
Terminated
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
poly-L-lactic acid
poly-L-lactic acid
Sponsored by
Kirby Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-Associated Lipodystrophy focused on measuring HIV, Lipodystrophy, Intervention, Poly-L-lactic acid, HIV facial lipoatrophy, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr Doong's Surgery
  • Royal Prince Alfred Hospital
  • 407 Doctors
  • AIDS Research Initiative
  • Albion Street Clinic
  • Holdsworth House General Practice
  • St. Vincent's Hospital
  • Taylor Square Private Clinic
  • Royal North Shore Hospital
  • Liverpool Health Service
  • Waratah Clinic, St. George Hospital
  • Westmead Hospital
  • Queensland Health - AIDS Medical Unit
  • Gladstone Road Medical Centre
  • Gold Coast Sexual Health Clinic
  • Clinic 87
  • The Care and Prevention Programme - Adelaide University
  • Royal Perth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate

Delayed

Arm Description

poly-L-lactic acid injections

poly-L-lactic acid injections

Outcomes

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).

Secondary Outcome Measures

Change from baseline at week 96 in facial soft tissue volume as measured by spiral CT scan
Change from baseline at weeks 24 and 96 in physician and patient assessment of facial lipoatrophy severity
Change from baseline at weeks 24 and 96 in peripheral fat as assessed by dual-energy X-ray absorptiometry (DEXA)
Change from baseline at weeks 24 and 96 in quality of life
Change from baseline at weeks 24 and 96 in antiretroviral therapy (ART) adherence and plasma HIV-RNA
All serious, grade 3 or 4 clinical adverse events and any adverse event leading to change/s in ART or discontinuation of PLA
All serious, grade 3 or 4 clinical adverse events (AEs) and any event leading to change/s in ART reported to week 96
All AEs attributable to study treatment reported to week 96

Full Information

First Posted
August 1, 2005
Last Updated
March 31, 2009
Sponsor
Kirby Institute
Collaborators
The University of New South Wales, Abbott, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme LLC, Hoffmann-La Roche, AIDS Council of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT00126308
Brief Title
Facial Lipoatrophy Trial: Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial Lipoatrophy
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Terminated
Why Stopped
no change in primary endpoint at week 48
Study Start Date
November 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kirby Institute
Collaborators
The University of New South Wales, Abbott, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme LLC, Hoffmann-La Roche, AIDS Council of New South Wales

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: to evaluate the extent and duration of improvement in HIV facial lipoatrophy of PLA injections; to evaluate the impact of PLA injections on quality of life and ART adherence in subjects with HIV facial lipoatrophy; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-Associated Lipodystrophy, HIV Infections
Keywords
HIV, Lipodystrophy, Intervention, Poly-L-lactic acid, HIV facial lipoatrophy, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate
Arm Type
Experimental
Arm Description
poly-L-lactic acid injections
Arm Title
Delayed
Arm Type
Active Comparator
Arm Description
poly-L-lactic acid injections
Intervention Type
Device
Intervention Name(s)
poly-L-lactic acid
Other Intervention Name(s)
Sculptra
Intervention Description
immediate injections poly-L-lactic acid (4 bilateral treatments - 8 vials)
Intervention Type
Device
Intervention Name(s)
poly-L-lactic acid
Other Intervention Name(s)
Sculptra
Intervention Description
delayed (24 weeks) poly-L-lactic acid injections (4 bilateral treatment - 8 vials)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change from baseline at week 96 in facial soft tissue volume as measured by spiral CT scan
Time Frame
96 weeks
Title
Change from baseline at weeks 24 and 96 in physician and patient assessment of facial lipoatrophy severity
Time Frame
24 and 96 weeks
Title
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
Title
Change from baseline at weeks 24 and 96 in quality of life
Time Frame
24 and 96 weeks
Title
Change from baseline at weeks 24 and 96 in antiretroviral therapy (ART) adherence and plasma HIV-RNA
Time Frame
24 and 96 weeks
Title
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
Title
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
Title
All AEs attributable to study treatment reported to week 96
Time Frame
week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Carr, A/Prof
Organizational Affiliation
Immunology and Infectious Disease Unit, St. Vincent's Hospital, Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Doong's Surgery
City
Burwood
State/Province
New South Wales
ZIP/Postal Code
2134
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
407 Doctors
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
AIDS Research Initiative
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Albion Street Clinic
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Holdsworth House General Practice
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St. Vincent's Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Taylor Square Private Clinic
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Royal North Shore Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Liverpool Health Service
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Waratah Clinic, St. George Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Queensland Health - AIDS Medical Unit
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4002
Country
Australia
Facility Name
Gladstone Road Medical Centre
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Gold Coast Sexual Health Clinic
City
Gold Coast
State/Province
Queensland
ZIP/Postal Code
4220
Country
Australia
Facility Name
Clinic 87
City
Nambour
State/Province
Queensland
ZIP/Postal Code
4560
Country
Australia
Facility Name
The Care and Prevention Programme - Adelaide University
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia

12. IPD Sharing Statement

Links:
URL
http://www.med.unsw.edu.au/nchecr/
Description
NCHECR Website (Australia)

Learn more about this trial

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

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