|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00148850 |
|
Date of registration:
|
07/09/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled Trial in 130 Patients
|
|
Scientific title:
|
A Randomized, Phase 3, Double Blind, Multicentre Trial, Evaluating the Effect of Pioglitazone Versus Placebo on Change in Lipoatrophy in HIV- 1 Infected Patients Treated With Stable Antiretroviral Therapy for at Least 6 Months.ANRS 113 LIPIOT Study |
|
Date of first enrolment:
|
February 2003 |
|
Target sample size:
|
130 |
|
Recruitment status: |
Terminated |
|
URL:
|
http://clinicaltrials.gov/show/NCT00148850 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Willy Rozenbaum, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hopital Tenon Paris |
|
|
Name:
|
Dominique Costagliola |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
INSERM U 720 |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
HIV Infections
|
|
HIV-Associated Lipodystrophy Syndrome
|
|
Intervention(s)
|
|
Drug: Pioglitazone
|
|
Primary Outcome(s)
|
|
Evolution from inclusion to week 48 of limb fat using DEXA Scan (Dual Energy X-ray Absorptiometry)
|
|
Secondary Outcome(s)
|
|
Anthropometric measurements and the quality of life (WHO-QOL-HIV BREF)
|
|
Lipid profile and the glucidic metabolism
|
|
Evaluation of clinical and biological safety
|
|
SAT/TAT and VAT/TAT ratios evaluated with scanner
|
|
X ray of L4
|
|
Changes from inclusion to week 48:
|
|
Secondary ID(s)
|
|
ANRS 113 LIPIOT
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|