NCT00148850

Brief Summary

The aim of this randomized study is to compare the effect of pioglitazone versus placebo on change in limb fat in HIV 1-infected patients treated with antiretroviral therapy for at least 6 months and with clinical lipoatrophy.

Trial Health

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Trial Health Score

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

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2003

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

October 20, 2005

Status Verified

September 1, 2005

First QC Date

September 7, 2005

Last Update Submit

October 19, 2005

Conditions

HIV-Associated Lipodystrophy SyndromeHIV Infections

Keywords

HIV-Associated Lipodystrophy SyndromepioglitazoneHIV infectionsTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Evolution from inclusion to week 48 of limb fat using DEXA Scan (Dual Energy X-ray Absorptiometry)

Secondary Outcomes (6)

  • Changes from inclusion to week 48:

  • Lipid profile and the glucidic metabolism

  • SAT/TAT and VAT/TAT ratios evaluated with scanner

  • X ray of L4

  • Anthropometric measurements and the quality of life (WHO-QOL-HIV BREF)

  • +1 more secondary outcomes

Interventions

PioglitazoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of ages and older
  • Confirmed laboratory diagnosis of HIV-1-infection
  • Karnofsky equal or over 70%
  • Patients treated with stable antiretroviral therapy for at least 6 months
  • Plasma viral load below 400 copies/ ml and CD4 count over 200/mm3 for at least 6 months
  • Patients with a clinical peripheral lipoatrophy self reported by the patient and confirmed by physical examination

You may not qualify if:

  • Cachexia
  • Cardiac failure class3 or 4 at NYHA classification
  • Acute opportunistic infection
  • Pregnancy or breast-feeding
  • Polynuclear neutrophils below 1000/mm3
  • Hemoglobin below 9 g/dl
  • Platelets below 50 000/mm3
  • Creatinine level over 2 UN
  • ASAT, ALAT over 2.5UN
  • Bilirubin, amylase, lipase level over 2 UN
  • CD4 count below 200/mm3
  • Patients treated by any antidiabetic or lipid lowering drugs, anabolic or corticosteroid hormone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des Maladies Infectieuses et Tropicales, Hopital Tenon

Paris, 75020, France

Location

Related Publications (1)

  • Slama L, Lanoy E, Valantin MA, Bastard JP, Chermak A, Boutekatjirt A, William-Faltaos D, Billaud E, Molina JM, Capeau J, Costagliola D, Rozenbaum W. Effect of pioglitazone on HIV-1-related lipodystrophy: a randomized double-blind placebo-controlled trial (ANRS 113). Antivir Ther. 2008;13(1):67-76.

    PMID: 18389900DERIVED

MeSH Terms

Conditions

HIV-Associated Lipodystrophy SyndromeHIV Infections

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesLipodystrophySkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Willy Rozenbaum, MD

    Hopital Tenon Paris

    PRINCIPAL INVESTIGATOR

  • Dominique Costagliola

    INSERM U 720

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

February 1, 2003

Study Completion

October 1, 2004

Last Updated

October 20, 2005

Record last verified: 2005-09

Locations

FR(1)