NCT00126308|TerminatedPhase 4

Study Stopped

no change in primary endpoint at week 48

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

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)

Kirby Institute ClinicalTrials.gov

Compare

2 other identifiers

V1-0 4-05ACTR012605000132640

Study Type

interventional

Target

100

Locations

1 country

Sites

Timeline

RegisteredAug 2005

StartedNov 2005

CompletionMay 2007

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started Nov 2005

Geographic Reach

1 country

18 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

August 1, 2005

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2005

Completed

3 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed

Last Updated

April 2, 2009

Status Verified

March 1, 2009

Enrollment Period

1.5 years

First QC Date

August 1, 2005

Last Update Submit

March 31, 2009

Conditions

HIV-Associated Lipodystrophy HIV Infections

Keywords

HIVLipodystrophyInterventionPoly-L-lactic acidHIV facial lipoatrophyTreatment Experienced

Outcome Measures

Primary Outcomes (1)

The primary endpoint at 24 weeks will be change from baseline in facial soft tissue volume as measured by spiral computed tomography (CT).
24 weeks

Secondary Outcomes (8)

Change from baseline at week 96 in facial soft tissue volume as measured by spiral CT scan
96 weeks
Change from baseline at weeks 24 and 96 in physician and patient assessment of facial lipoatrophy severity
24 and 96 weeks
Change from baseline at weeks 24 and 96 in peripheral fat as assessed by dual-energy X-ray absorptiometry (DEXA)
24 and 96 weeks
Change from baseline at weeks 24 and 96 in quality of life
24 and 96 weeks
Change from baseline at weeks 24 and 96 in antiretroviral therapy (ART) adherence and plasma HIV-RNA
24 and 96 weeks
+3 more secondary outcomes

Study Arms (2)

Immediate

EXPERIMENTAL

poly-L-lactic acid injections

Device: poly-L-lactic acid

Delayed

ACTIVE COMPARATOR

poly-L-lactic acid injections

Device: poly-L-lactic acid

Interventions

poly-L-lactic acidDEVICE

immediate injections poly-L-lactic acid (4 bilateral treatments - 8 vials)

Also known as: Sculptra

Immediate

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Study Sites (18)

Dr Doong's Surgery

Burwood, New South Wales, 2134, Australia

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

407 Doctors