Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126308
Status:
TERMINATED
Last Update Posted:
2009-04-02
First Post:
2005-08-01
Brief Title:
Facial Lipoatrophy Trial Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial Lipoatrophy
Sponsor:
Kirby Institute
Organization:
Kirby Institute
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no change in primary endpoint at week 48
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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
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 major concern To date as there is no proven therapy for lipoatrophy cosmetic interventions for facial lipoatrophy are being studied Poly-L-lactic acid PLA has been shown to be both safe and effective when administered by injection to facial areas
Study aims are
1 to evaluate the extent and duration of improvement in HIV facial lipoatrophy of PLA injections
2 to evaluate the impact of PLA injections on quality of life and ART adherence in subjects with HIV facial lipoatrophy
3 to evaluate the safety and tolerability of polylactic acid
100 HIV-infected ART-experienced subjects with facial lipoatrophy will be randomised in a 11 ratio at study entry to receive either immediate or deferred treatment delayed 24 weeks treatment with PLA Randomisation will be stratified by age severity of facial lipoatrophy current ART PI or non-PI containing and thymidine- or non-thymidine-containing and surgeon
The study has clinical end points monitoring CD4 cell counts viral loads and adverse events The study also has psychosocial end points monitoring quality of life
Study aims are
1 to evaluate the extent and duration of improvement in HIV facial lipoatrophy of PLA injections
2 to evaluate the impact of PLA injections on quality of life and ART adherence in subjects with HIV facial lipoatrophy
3 to evaluate the safety and tolerability of polylactic acid
100 HIV-infected ART-experienced subjects with facial lipoatrophy will be randomised in a 11 ratio at study entry to receive either immediate or deferred treatment delayed 24 weeks treatment with PLA Randomisation will be stratified by age severity of facial lipoatrophy current ART PI or non-PI containing and thymidine- or non-thymidine-containing and surgeon
The study has clinical end points monitoring CD4 cell counts viral loads and adverse events The study also has psychosocial end points monitoring quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTR012605000132640 | None | None | None |