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

NCT00126308 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2009-04-02

No results posted yet for this study

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.

Conditions

  • HIV-Associated Lipodystrophy
  • HIV Infections

Interventions

DEVICE

poly-L-lactic acid

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

DEVICE

poly-L-lactic acid

delayed (24 weeks) poly-L-lactic acid injections (4 bilateral treatment - 8 vials)

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00126308 on ClinicalTrials.gov