Status:
TERMINATED
Facial Lipoatrophy Trial: Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial Lipoatrophy
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
The University of New South Wales
Abbott
Conditions:
HIV-Associated Lipodystrophy
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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,...
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00126308
Start Date
November 1 2005
End Date
May 1 2007
Last Update
April 2 2009
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Dr Doong's Surgery
Burwood, New South Wales, Australia, 2134
2
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
3
407 Doctors
Sydney, New South Wales, Australia, 2010
4
AIDS Research Initiative
Sydney, New South Wales, Australia, 2010