None listed
Conditions
Interventions
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.
Sponsors
The University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Laboratory evidence of HIV-1 infection- received combination antiretroviral therapy (min 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.
Outcome results
None listed