Facial Lipoatrophy Trial

Phase 4

• Conditions: HIV Facial Lipoatrophy; Inflammatory and Immune System - Rheumatoid arthritis

• Registration Number: ACTRN12605000132640
• Lead Sponsor: The University of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in facial soft tissue volume as measured by spiral computed tomography (CT).[At 24 weeks.]

Secondary Outcome Measures

Name	Time	Method
Facial soft tissue volume as measured by spiral CT scan.[Change from baseline at week 9.];Physician and patient assessment of facial lipoatrophy severity.[Change from baseline at weeks 24 and 96.];Peripheral fat as assessed by dual-energy X-ray absorptiometry (DEXA).[Change from baseline at weeks 24 and 96.];Quality of life[Change from baseline at weeks 24 and 96.];Antiretroviral therapy adherence and plasma HIV-RNA[Change from baseline at weeks 24 and 96.];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.]