Completed PHASE3 INTERVENTIONAL 2-arm NCT00383734

Safety and Efficacy of Intradermal Injections of Newfill Versus Eutrophill in the Treatment of Facial Lipoatrophy in HIV-infected Patients ANRS 132 SMILE

Randomized, Comparative, Multicenter, Patient-blinded Trial of the Safety and Efficacy of Intradermal Injections of Polylactic Acid (Newfill TM) Versus Polyacrylamid Gel (Eutrophill) in the Treatment of Facial Lipoatrophy in HIV-infected Patients ANRS 132 SMILE

Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Conditions HIV-Associated Lipodystrophy Syndrome

Interventions Eutrophill Newfill

Updated 5 times since 2017 Last updated: Dec 21, 2011 Started: Dec 31, 2006 Primary completion: Sep 30, 2008 Completion: Sep 30, 2010

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on HIV-Associated Lipodystrophy Syndrome, this trial is completed. The trial is conducted by French National Agency for Research on AIDS and Viral Hepatitis and has accumulated 5 data snapshots since 2006. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Dec 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

French National Agency for Research on AIDS and Viral Hepatitis
Procitech
Sanofi

Data source: French National Agency for Research on AIDS and Viral Hepatitis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Paris, France