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	Procedure: Poly-L-lactic acid	Phase IV

Further Study Details: 

Primary Outcomes: The primary endpoint at 24 weeks will be change from baseline in facial soft tissue volume as measured by spiral computed tomography (CT).
Secondary Outcomes: 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
Expected Total Enrollment:  100

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Aged 18 years or more with 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00126308

Dianne Carey      +61 2 9385 0900    dcarey@nchecr.unsw.edu.au

Australia, New South Wales
      St. Vincent''''s Hospital, Sydney,  New South Wales,  2010,  Australia

Study chairs or principal investigators

Andrew Carr, A/Prof,  Principal Investigator,  Immunology and Infectious Disease Unit, St. Vincent''''s Hospital, Sydney   

Study ID Numbers:  V1-0 4-05
Last Updated:  August 17, 2005
Record first received:  August 1, 2005
ClinicalTrials.gov Identifier:  NCT00126308
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
ClinicalTrials.gov processed this record on 2005-08-23